Colectomy, Laparotomy
Conditions
Brief summary
The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.
Detailed description
Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs. Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case. The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.
Interventions
DRUGExparel
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
OTHERThoracic epidural analgesia
Historical cohort that received thoracic epidural analgesia
Sponsors
Pacira Pharmaceuticals, Inc
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective, laparoscopic colonic resection by one of three surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the same manner * Age 18-85 years * American Society of Anesthesiologists (ASA) Physical Class I-III * BMI 18-35 kg/m\^2
Exclusion criteria
* Inability to consent * Inability to speak English * Pregnancy * Emergency surgery * Contraindications to regional blockade: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics * Allergies/intolerances/contraindications to any of the multimodal agents (acetaminophen, gabapentin, ketorolac) * Daily opioid equivalent use of 30 mg of morphine or greater at time of consent * History of drug or alcohol abuse * Rheumatoid arthritis * Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments of compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Opioid Consumption Over 48 Hours | From arrival to PACU to 48 hours post-operatively | Measured in morphine milligram equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration | The NRS-11 is an 11-point scale where 10=worst pain imaginable and 0= no pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Postoperative Pain Control | Up to 48 hours post Exparel administration | Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied. |
| Hospital Length of Stay | From administration of Exparel through hospital discharge | Measured both by raw length of stay and by time to achieving discharge readiness, defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower). |
| Number of Participants With Opioid-related Adverse Events | From administration of Exparel through 168 hours post Exparel administration | Adverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression. |
| Number of Participants With Block Success | 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration | Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels sharp or dull, indicating block failure and success respectively. |
| Cost | From time of arrival in PACU through 96 hours post Exparel administration | Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated. |
| Sleep Quality as Measured by Two Questions | Up to 168 hours post Exparel administration | Each question has a scale of 0 (no interference) to 10 (completely interferes) and the two scores are averaged: How much did pain interfere with falling asleep?, How much did pain interfere with staying asleep? |
| Time to First Mobilization | From time of arrival in PACU through first mobilization | — |
| Number of Participants With Adverse Events Related to the Block | From administration of Exparel through 168 hours post Exparel administration | Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block). |
Countries
United States
Participant flow
Pre-assignment details
Historical Controls were not considered enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Quadratus Lumborum Block Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. | 30 |
| Thoracic Epidural Analgesia Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Intraoperative conversion of surgery from laparoscopic to open | 5 | 0 |
Baseline characteristics
| Characteristic | Quadratus Lumborum Block | Total | Thoracic Epidural Analgesia |
|---|---|---|---|
| Age, Continuous | 63 years | 63 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 60 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 50 Participants | 23 Participants |
| Region of Enrollment United States | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 15 Participants | 32 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 28 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 10 / 30 | 19 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 |
Outcome results
Primary
Cumulative Opioid Consumption Over 48 Hours
Measured in morphine milligram equivalents.
Time frame: From arrival to PACU to 48 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum Block | Cumulative Opioid Consumption Over 48 Hours | 33 morphine milligram equivalents |
| Thoracic Epidural Analgesia | Cumulative Opioid Consumption Over 48 Hours | 61 morphine milligram equivalents |
Secondary
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
The NRS-11 is an 11-point scale where 10=worst pain imaginable and 0= no pain.
Time frame: 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration
Population: Data not collected at 144 hours or 168 hours.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 30 minutes | 5 score on a scale |
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 8 hours | 3 score on a scale |
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 24 hours | 3 score on a scale |
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 36 hours | 2 score on a scale |
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 48 hours | 4 score on a scale |
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 72 hours | 2 score on a scale |
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 96 hours | 2 score on a scale |
| Quadratus Lumborum Block | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 120 hours | 2 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 120 hours | 5 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 30 minutes | 4 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 48 hours | 3 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 8 hours | 0 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 96 hours | 5 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 24 hours | 2 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 72 hours | 3 score on a scale |
| Thoracic Epidural Analgesia | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | 36 hours | 2 score on a scale |
Other Pre-specified
Cost
Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated.
Time frame: From time of arrival in PACU through 96 hours post Exparel administration
Population: Data not collected.
Other Pre-specified
Hospital Length of Stay
Measured both by raw length of stay and by time to achieving discharge readiness, defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower).
Time frame: From administration of Exparel through hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum Block | Hospital Length of Stay | 27 hours |
| Thoracic Epidural Analgesia | Hospital Length of Stay | 55 hours |
Other Pre-specified
Number of Participants With Adverse Events Related to the Block
Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block).
Time frame: From administration of Exparel through 168 hours post Exparel administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadratus Lumborum Block | Number of Participants With Adverse Events Related to the Block | 6 Participants |
| Thoracic Epidural Analgesia | Number of Participants With Adverse Events Related to the Block | 8 Participants |
Other Pre-specified
Number of Participants With Block Success
Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels sharp or dull, indicating block failure and success respectively.
Time frame: 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadratus Lumborum Block | Number of Participants With Block Success | 7 Participants |
| Thoracic Epidural Analgesia | Number of Participants With Block Success | 1 Participants |
Other Pre-specified
Number of Participants With Opioid-related Adverse Events
Adverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression.
Time frame: From administration of Exparel through 168 hours post Exparel administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadratus Lumborum Block | Number of Participants With Opioid-related Adverse Events | 10 Participants |
| Thoracic Epidural Analgesia | Number of Participants With Opioid-related Adverse Events | 19 Participants |
Other Pre-specified
Satisfaction With Postoperative Pain Control
Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied.
Time frame: Up to 48 hours post Exparel administration
Population: Not applicable to the historical thoracic epidural analgesia group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum Block | Satisfaction With Postoperative Pain Control | 8 score on a scale |
Other Pre-specified
Sleep Quality as Measured by Two Questions
Each question has a scale of 0 (no interference) to 10 (completely interferes) and the two scores are averaged: How much did pain interfere with falling asleep?, How much did pain interfere with staying asleep?
Time frame: Up to 168 hours post Exparel administration
Population: Not applicable to the historical thoracic epidural analgesia group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum Block | Sleep Quality as Measured by Two Questions | 4 score on a scale |
Other Pre-specified
Time to First Mobilization
Time frame: From time of arrival in PACU through first mobilization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quadratus Lumborum Block | Time to First Mobilization | 15 hours |
| Thoracic Epidural Analgesia | Time to First Mobilization | 31 hours |