Pain, Postoperative
Conditions
Keywords
laparoscopy, hysterectomy
Brief summary
The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.
Interventions
DRUGLocal anesthesia at incision site
20 ml of 0.25% Bupivacaine will be given at incision site
DRUGSham QL
20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia
DRUGSham Local
20 mls of normal saline given at incision site
DRUGQL
QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English or Spanish speaking * American Society of Anesthesiologists (ASA) physical status 1-3 * Planned laparoscopic or robotic hysterectomy
Exclusion criteria
* History of chronic pain requiring preoperative opioids, Known alcoholism disorder * Congenital coagulopathy, * Localized soft tissue infection, * Use of anticoagulants, * Dementia, inability or refusal to provide consent for the surgery * Morbid obesity (BMI \> 50), due to expected technical difficulty to achieve the block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 24 hours after anesthesia | The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome. |
| Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 24 hours after anesthesia | The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome. |
| Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 24 hours after anesthesia | The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain. |
| Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 24 hours after anesthesia | The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome. |
| Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 24 hours after anesthesia | The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome. |
| Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 24 hours after anesthesia | The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Needed to Administer the Intervention QL Block | Time to administration of intervention QL block | — |
| Time to Administration of First Pain Medication in PACU | From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes) | — |
| Pain at Rest as Assessed by the Visual Analog Scale | Post anesthesia care unit (PACU) immediately postoperatively | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain |
| Pain at Dynamic as Assessed by the Visual Analog Scale | Day 1 (24+/=4 hours post surgery) | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain |
| Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | in PACU(upto 8 hours after surgery) | — |
| Number of Participants With Complications Related to a Study Intervention | 30 days | — |
| Postoperative Nausea and Vomiting (PONV) Score Before Discharge | about 24 hours | Postoperative Nausea and Vomiting (PONV) score before discharge Scale: (none, mild, moderate) |
Other
| Measure | Time frame |
|---|---|
| Number of Participants That Required Morcellation | Intraoperative (about 3 hours) |
| Number of Participants With Intraoperative Complications | Intraoperative (about 3 hours) |
| Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes | about 3 hours |
| Number of Participants That Were Discharge on the Same Day | Hospital discharge (up to 24 hours) |
| Duration of Surgery | about 3 hours |
| Specimen Weight | inoperative (about 3 hours) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Local Anesthesia at Incision Site Local anesthesia at incision site: 20 ml of 0.25% Bupivacaine will be given at incision site
Sham QL: 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia | 38 |
| QL Block Sham Local: 20 mls of normal saline given at incision site
QL: QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | Local Anesthesia at Incision Site | QL Block | Total |
|---|---|---|---|
| Age, Continuous | 44 years | 45 years | 44 years |
| American Society of Anesthesiology (ASA) Classification ASA I :A normal healthy patient | 21 Participants | 21 Participants | 42 Participants |
| American Society of Anesthesiology (ASA) Classification ASA II :A patient with mild systemic disease | 17 Participants | 17 Participants | 34 Participants |
| American Society of Anesthesiology (ASA) Classification ASA III: A patient with severe systemic disease | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA IV: A patient with severe systemic disease that is a constant threat to life | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA V: A moribund patient who is not expected to survive without the operation | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiology (ASA) Classification ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | 0 Participants | 0 Participants | 0 Participants |
| Body Mass Index | 30 kg/m^2 | 35 kg/m^2 | 32.8 kg/m^2 |
| History of Previous Uterine Surgery | 29 Participants | 33 Participants | 62 Participants |
| Indication for the surgery Other (adenomyosis, polys, abnormal bleeding) | 13 Participants | 16 Participants | 29 Participants |
| Indication for the surgery Symptomatic fibroids | 25 Participants | 22 Participants | 47 Participants |
| Number of Participants who are Nulliparous | 10 Participants | 8 Participants | 18 Participants |
| Race/Ethnicity, Customized Black or African American | 21 Participants | 15 Participants | 36 Participants |
| Race/Ethnicity, Customized Other/Unknown/Not Reported | 3 Participants | 10 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 13 Participants | 27 Participants |
| Region of Enrollment United States | 38 participants | 38 participants | 76 participants |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 76 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgery Type Conversion to Open | 0 Participants | 1 Participants | 1 Participants |
| Surgery Type Laparoscopic | 4 Participants | 3 Participants | 7 Participants |
| Surgery Type Robotic | 34 Participants | 34 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 12 / 38 | 14 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome.
Time frame: 24 hours after anesthesia
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 42.2 score on a scale | Standard Deviation 2.7 |
| QL Block | Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 42.1 score on a scale | Standard Deviation 4 |
Primary
Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain.
Time frame: 24 hours after anesthesia
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 30.0 score on a scale | Standard Deviation 2.8 |
| QL Block | Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 31.1 score on a scale | Standard Deviation 2.2 |
Primary
Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome.
Time frame: 24 hours after anesthesia
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 52.9 score on a scale | Standard Deviation 4.9 |
| QL Block | Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 54.3 score on a scale | Standard Deviation 5.1 |
Primary
Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome.
Time frame: 24 hours after anesthesia
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 20.4 score on a scale | Standard Deviation 3 |
| QL Block | Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 21.3 score on a scale | Standard Deviation 2.4 |
Primary
Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome.
Time frame: 24 hours after anesthesia
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 30.2 score on a scale | Standard Deviation 2.8 |
| QL Block | Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 30.3 score on a scale | Standard Deviation 1.7 |
Primary
Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome
Time frame: 24 hours after anesthesia
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 175.6 score on a scale | Standard Deviation 9.7 |
| QL Block | Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | 179.1 score on a scale | Standard Deviation 10.3 |
Secondary
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: in PACU(upto 8 hours after surgery)
Population: Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 4 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 9.77 milligrams | Standard Deviation 5.3 |
| QL Block | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 13.5 milligrams | Standard Deviation 19 |
Secondary
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: 6 weeks post surgery
Population: Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 58.2 milligrams | Standard Deviation 43.9 |
| QL Block | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 60.69 milligrams | Standard Deviation 58.7 |
Secondary
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: 24 hours after surgery
Population: Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 5 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 36.48 milligrams | Standard Deviation 25 |
| QL Block | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 36.57 milligrams | Standard Deviation 24.8 |
Secondary
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: 2 weeks post surgery
Population: Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 58.2 milligrams | Standard Deviation 43.9 |
| QL Block | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 60.69 milligrams | Standard Deviation 58.7 |
Secondary
Number of Participants With Complications Related to a Study Intervention
Time frame: 30 days
Population: Data were not collected for 1 participant in the QL block arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthesia at Incision Site | Number of Participants With Complications Related to a Study Intervention | 0 Participants |
| QL Block | Number of Participants With Complications Related to a Study Intervention | 0 Participants |
Secondary
Pain at Dynamic as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: Day 14 post surgery
Population: Data was not collected for 2 participants in the Local Anesthesia at incision site arm. Data was not collected for 7 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Dynamic as Assessed by the Visual Analog Scale | 3.4 score on a scale | Standard Deviation 2.2 |
| QL Block | Pain at Dynamic as Assessed by the Visual Analog Scale | 3 score on a scale | Standard Deviation 2.5 |
Secondary
Pain at Dynamic as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: 6 weeks post surgery
Population: Data were not collected for 9 participants in the Local Anesthesia at incision site arm. Data were not collected for 4 participants in the QL Block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Dynamic as Assessed by the Visual Analog Scale | 0.8 score on a scale | Standard Deviation 1.5 |
| QL Block | Pain at Dynamic as Assessed by the Visual Analog Scale | 1 score on a scale | Standard Deviation 1.8 |
Secondary
Pain at Dynamic as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: Day 1 (24+/=4 hours post surgery)
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Dynamic as Assessed by the Visual Analog Scale | 6.9 score on a scale | Standard Deviation 2.2 |
| QL Block | Pain at Dynamic as Assessed by the Visual Analog Scale | 6.7 score on a scale | Standard Deviation 2.5 |
Secondary
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: Post anesthesia care unit (PACU) immediately postoperatively
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 3 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Rest as Assessed by the Visual Analog Scale | 2.2 score on a scale | Standard Deviation 3.6 |
| QL Block | Pain at Rest as Assessed by the Visual Analog Scale | 2.4 score on a scale | Standard Deviation 3.8 |
Secondary
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: At the time of first opiate administration(upto one day after surgery)
Population: Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 3 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Rest as Assessed by the Visual Analog Scale | 7.6 score on a scale | Standard Deviation 1.7 |
| QL Block | Pain at Rest as Assessed by the Visual Analog Scale | 7.4 score on a scale | Standard Deviation 2 |
Secondary
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: At the time of discharge (upto 3 days after surgery)
Population: Data was not collected for 7 participants in the Local Anesthesia at incision site arm. Data was not collected for 9 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Rest as Assessed by the Visual Analog Scale | 1.4 score on a scale | Standard Deviation 1.8 |
| QL Block | Pain at Rest as Assessed by the Visual Analog Scale | 1.3 score on a scale | Standard Deviation 1.9 |
Secondary
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: Day 1 (24+/=4 hours post surgery)
Population: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Rest as Assessed by the Visual Analog Scale | 4.5 score on a scale | Standard Deviation 2.2 |
| QL Block | Pain at Rest as Assessed by the Visual Analog Scale | 4.5 score on a scale | Standard Deviation 2.6 |
Secondary
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: Day 14 post surgery
Population: Data was not collected for 2 participants in the Local Anesthesia at incision site arm. Data was not collected for 7 participants in the QL block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Rest as Assessed by the Visual Analog Scale | 2 score on a scale | Standard Deviation 1.9 |
| QL Block | Pain at Rest as Assessed by the Visual Analog Scale | 1.8 score on a scale | Standard Deviation 2 |
Secondary
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time frame: 6 weeks post surgery
Population: Data were not collected for 9 participants in the Local Anesthesia at incision site arm. Data were not collected for 4 participants in the QL Block arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Pain at Rest as Assessed by the Visual Analog Scale | 0 score on a scale | Standard Deviation 1 |
| QL Block | Pain at Rest as Assessed by the Visual Analog Scale | 1 score on a scale | Standard Deviation 2 |
Secondary
Postoperative Nausea and Vomiting (PONV) Score Before Discharge
Postoperative Nausea and Vomiting (PONV) score before discharge Scale: (none, mild, moderate)
Time frame: about 24 hours
Population: Data were not collected for 3 participants in the QL block arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Local Anesthesia at Incision Site | Postoperative Nausea and Vomiting (PONV) Score Before Discharge | None | 27 Participants |
| Local Anesthesia at Incision Site | Postoperative Nausea and Vomiting (PONV) Score Before Discharge | Mild | 8 Participants |
| Local Anesthesia at Incision Site | Postoperative Nausea and Vomiting (PONV) Score Before Discharge | Moderate | 3 Participants |
| QL Block | Postoperative Nausea and Vomiting (PONV) Score Before Discharge | None | 24 Participants |
| QL Block | Postoperative Nausea and Vomiting (PONV) Score Before Discharge | Mild | 9 Participants |
| QL Block | Postoperative Nausea and Vomiting (PONV) Score Before Discharge | Moderate | 2 Participants |
Secondary
Time Needed to Administer the Intervention QL Block
Time frame: Time to administration of intervention QL block
Population: Data were not collected for this outcome measure
Secondary
Time to Administration of First Pain Medication in PACU
Time frame: From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes)
Population: Data were not collected for 1 participant in the QL block
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Time to Administration of First Pain Medication in PACU | 63.3 minutes | Standard Deviation 49 |
| QL Block | Time to Administration of First Pain Medication in PACU | 88.7 minutes | Standard Deviation 85 |
Other Pre-specified
Duration of Surgery
Time frame: about 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Duration of Surgery | 176 minutes | Standard Deviation 62 |
| QL Block | Duration of Surgery | 178 minutes | Standard Deviation 58 |
Other Pre-specified
Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes
Time frame: about 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthesia at Incision Site | Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes | 10 Participants |
| QL Block | Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes | 12 Participants |
Other Pre-specified
Number of Participants That Required Morcellation
Time frame: Intraoperative (about 3 hours)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Local Anesthesia at Incision Site | Number of Participants That Required Morcellation | Umbilical extraction site | 9 Participants |
| Local Anesthesia at Incision Site | Number of Participants That Required Morcellation | Mini Laparotomy extraction site | 3 Participants |
| Local Anesthesia at Incision Site | Number of Participants That Required Morcellation | Vaginal extraction site | 8 Participants |
| QL Block | Number of Participants That Required Morcellation | Umbilical extraction site | 7 Participants |
| QL Block | Number of Participants That Required Morcellation | Mini Laparotomy extraction site | 2 Participants |
| QL Block | Number of Participants That Required Morcellation | Vaginal extraction site | 4 Participants |
Other Pre-specified
Number of Participants That Were Discharge on the Same Day
Time frame: Hospital discharge (up to 24 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthesia at Incision Site | Number of Participants That Were Discharge on the Same Day | 30 Participants |
| QL Block | Number of Participants That Were Discharge on the Same Day | 28 Participants |
Other Pre-specified
Number of Participants With Intraoperative Complications
Time frame: Intraoperative (about 3 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthesia at Incision Site | Number of Participants With Intraoperative Complications | 0 Participants |
| QL Block | Number of Participants With Intraoperative Complications | 1 Participants |
Other Pre-specified
Specimen Weight
Time frame: inoperative (about 3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia at Incision Site | Specimen Weight | 414.1 grams | Standard Deviation 521 |
| QL Block | Specimen Weight | 297 grams | Standard Deviation 266 |