Pain, Postoperative
Conditions
Keywords
quadratus lumborum block, post-operative pain, cesarean section pain, analgesia, nerve block
Brief summary
Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.
Detailed description
The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia. Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain). Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline. For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions. The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia). The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.
Interventions
DRUGITM + Sham QLB
Sham subcutaneous non-anesthetic infiltration with saline
DRUGITM + Bupivacaine QLB
QL plane block with local anesthesia
Sponsors
Nicholas Schott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Elective cesarean planned under spinal anesthesia * Singleton pregnancy * American Society of Anesthesiologists (ASA) classification score of 2 (or less) * Gestational age of at least 37 weeks * Intention to breastfeed infant
Exclusion criteria
* Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry) * Anatomical abnormalities contraindicating spinal or QLB placement * Received/Conversion to general anesthesia * Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure) * History of chronic pain * History of chronic opioid use/abuse * History of Subutex, methadone, other maintenance therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score With Movement | 24 hours after surgical procedure (cesarean delivery) | Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score at Rest | 1 hour after intervention | VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible. |
| First Request for Pain Medication | From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours | Time to first opioid dose (measured in hours) |
| Sedation | 24-hours post-operative | Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response. |
| Pruritis | 4-hours post-operative | Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching |
| Nausea/Vomiting | 4-hours post-operative | Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment |
| Breast Feeding Success/Quality | 24-hours post-operatively | Limited breastfeeding resulting from pain or opioid side effects |
| Respiratory Rate | 4-hours post-operative | Will be measured in rate/min per standard of care and documented by study staff |
| Oxygen Saturation | 4-hours post-operative | Will be measured in % per standard of care and documented by study staff |
| Heart Rate | 4-hours post-operative | Standard heart rate obtained |
| Diastolic Blood Pressure | 4-hours post-operative | Will be measured in mmHG per standard of care and documented by study staff. |
| Systolic Blood Pressure | 4-hours post-operative | Will be measured in mmHG per standard of care and documented by study staff. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ITM + Sham QLB Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Sham QLB: Sham subcutaneous non-anesthetic infiltration with saline | 10 |
| ITM + Bupivacaine QLB Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
ITM + Bupivacaine QLB: QL plane block with local anesthesia | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Total | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 10 Participants | 11 Participants |
| Age, Continuous | 32.55 Years STANDARD_DEVIATION 4.66 | 31.80 Years STANDARD_DEVIATION 4.16 | 33.35 Years STANDARD_DEVIATION 5.17 |
| Gravidity | 2.79 Number of pregnancies STANDARD_DEVIATION 1.4 | 2.93 Number of pregnancies STANDARD_DEVIATION 1.67 | 2.64 Number of pregnancies STANDARD_DEVIATION 1.08 |
| Parity | 1.10 Number of births STANDARD_DEVIATION 0.67 | 1.27 Number of births STANDARD_DEVIATION 0.8 | 0.93 Number of births STANDARD_DEVIATION 0.47 |
| Race/Ethnicity, Customized American Indian / Alaskan Native (not Hispanic or Latino) | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (not Hispanic or Latino) | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American (not Hispanic or Latino) | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Declined to answer | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White, Caucasian (not Hispanic or Latino) | 21 Participants | 10 Participants | 11 Participants |
| Region of Enrollment United States | 29 participants | 15 participants | 14 participants |
| Sex: Female, Male Female | 21 Participants | 10 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
Visual Analogue Scale (VAS) Pain Score With Movement
Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 24 hours after surgical procedure (cesarean delivery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Visual Analogue Scale (VAS) Pain Score With Movement | 4.85 Units on a scale | Standard Deviation 2.23 |
| ITM + Bupivacaine QLB | Visual Analogue Scale (VAS) Pain Score With Movement | 3.14 Units on a scale | Standard Deviation 1.83 |
Secondary
Breast Feeding Success/Quality
Limited breastfeeding resulting from pain or opioid side effects
Time frame: 24-hours post-operatively
Population: This data was not collected during the duration of this study.
Secondary
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 4-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Diastolic Blood Pressure | 71.15 mmHg | Standard Deviation 9.21 |
| ITM + Bupivacaine QLB | Diastolic Blood Pressure | 70.36 mmHg | Standard Deviation 2.29 |
Secondary
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 48-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Diastolic Blood Pressure | 75.80 mmHg | Standard Deviation 9.09 |
| ITM + Bupivacaine QLB | Diastolic Blood Pressure | 76.50 mmHg | Standard Deviation 7.78 |
Secondary
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 24-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Diastolic Blood Pressure | 68.00 mmHg | Standard Deviation 7.96 |
| ITM + Bupivacaine QLB | Diastolic Blood Pressure | 70.67 mmHg | Standard Deviation 8.96 |
Secondary
First Request for Pain Medication
Time to first opioid dose (measured in hours)
Time frame: From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | First Request for Pain Medication | 17.30 Hours | Standard Deviation 14.9 |
| ITM + Bupivacaine QLB | First Request for Pain Medication | 17.37 Hours | Standard Deviation 14.29 |
Secondary
Heart Rate
Standard heart rate obtained
Time frame: 24-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Heart Rate | 86.86 Heartbeats/minute | Standard Deviation 10.24 |
| ITM + Bupivacaine QLB | Heart Rate | 91.33 Heartbeats/minute | Standard Deviation 6.15 |
Secondary
Heart Rate
Standard heart rate obtained
Time frame: 48-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Heart Rate | 87.00 Heartbeats/minute | Standard Deviation 7.55 |
| ITM + Bupivacaine QLB | Heart Rate | 86.50 Heartbeats/minute | Standard Deviation 3.54 |
Secondary
Heart Rate
Standard heart rate obtained
Time frame: 4-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Heart Rate | 82.62 Heartbeats/minute | Standard Deviation 10.63 |
| ITM + Bupivacaine QLB | Heart Rate | 78.86 Heartbeats/minute | Standard Deviation 15.94 |
Secondary
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Time frame: 48-hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITM + Sham QLB | Nausea/Vomiting | Score 3 | 0 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 1 | 2 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 0 | 8 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 2 | 0 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 3 | 0 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 2 | 0 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 0 | 11 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 1 | 0 Participants |
Secondary
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Time frame: 4-hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITM + Sham QLB | Nausea/Vomiting | Score 0 | 6 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 1 | 2 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 2 | 2 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 3 | 0 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 3 | 0 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 0 | 10 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 2 | 1 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 1 | 0 Participants |
Secondary
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Time frame: 24-hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITM + Sham QLB | Nausea/Vomiting | Score 0 | 9 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 1 | 1 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 2 | 0 Participants |
| ITM + Sham QLB | Nausea/Vomiting | Score 3 | 0 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 3 | 0 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 0 | 10 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 2 | 1 Participants |
| ITM + Bupivacaine QLB | Nausea/Vomiting | Score 1 | 0 Participants |
Secondary
Oxygen Saturation
Will be measured in % per standard of care and documented by study staff
Time frame: 4-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Oxygen Saturation | 96.6 percentage of SpO2 | Standard Deviation 2.07 |
| ITM + Bupivacaine QLB | Oxygen Saturation | 98.4 percentage of SpO2 | Standard Deviation 2.07 |
Secondary
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Time frame: 24-hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITM + Sham QLB | Pruritis | Group 0 | 5 Participants |
| ITM + Sham QLB | Pruritis | Group 3 | 1 Participants |
| ITM + Sham QLB | Pruritis | Group 1 | 2 Participants |
| ITM + Sham QLB | Pruritis | Group 2 | 2 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 3 | 1 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 2 | 2 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 1 | 3 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 0 | 5 Participants |
Secondary
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Time frame: 4-hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITM + Sham QLB | Pruritis | Group 0 | 4 Participants |
| ITM + Sham QLB | Pruritis | Group 1 | 2 Participants |
| ITM + Sham QLB | Pruritis | Group 2 | 3 Participants |
| ITM + Sham QLB | Pruritis | Group 3 | 1 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 3 | 1 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 0 | 3 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 2 | 2 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 1 | 5 Participants |
Secondary
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Time frame: 48-hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITM + Sham QLB | Pruritis | Group 0 | 8 Participants |
| ITM + Sham QLB | Pruritis | Group 1 | 1 Participants |
| ITM + Sham QLB | Pruritis | Group 2 | 1 Participants |
| ITM + Sham QLB | Pruritis | Group 3 | 0 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 3 | 0 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 0 | 10 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 2 | 1 Participants |
| ITM + Bupivacaine QLB | Pruritis | Group 1 | 0 Participants |
Secondary
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Time frame: 48-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Respiratory Rate | 16.40 Breaths/minute | Standard Deviation 2.19 |
| ITM + Bupivacaine QLB | Respiratory Rate | 18.00 Breaths/minute | Standard Deviation 0 |
Secondary
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Time frame: 4-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Respiratory Rate | 16.54 Breaths/minute | Standard Deviation 1.76 |
| ITM + Bupivacaine QLB | Respiratory Rate | 16.07 Breaths/minute | Standard Deviation 1.27 |
Secondary
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Time frame: 24-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Respiratory Rate | 16.29 Breaths/minute | Standard Deviation 2.93 |
| ITM + Bupivacaine QLB | Respiratory Rate | 16.67 Breaths/minute | Standard Deviation 1.51 |
Secondary
Sedation
Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.
Time frame: 24-hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITM + Sham QLB | Sedation | Score 1 | 0 Participants |
| ITM + Sham QLB | Sedation | Score 2 | 10 Participants |
| ITM + Sham QLB | Sedation | Score 3 | 0 Participants |
| ITM + Sham QLB | Sedation | Score 4 | 0 Participants |
| ITM + Sham QLB | Sedation | Score 5 | 0 Participants |
| ITM + Sham QLB | Sedation | Score 6 | 0 Participants |
| ITM + Bupivacaine QLB | Sedation | Score 5 | 0 Participants |
| ITM + Bupivacaine QLB | Sedation | Score 1 | 0 Participants |
| ITM + Bupivacaine QLB | Sedation | Score 4 | 0 Participants |
| ITM + Bupivacaine QLB | Sedation | Score 2 | 11 Participants |
| ITM + Bupivacaine QLB | Sedation | Score 6 | 0 Participants |
| ITM + Bupivacaine QLB | Sedation | Score 3 | 0 Participants |
Secondary
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 24-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Systolic Blood Pressure | 109.29 mmHg | Standard Deviation 9.41 |
| ITM + Bupivacaine QLB | Systolic Blood Pressure | 111.00 mmHg | Standard Deviation 11.4 |
Secondary
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 48-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Systolic Blood Pressure | 117.6 mmHg | Standard Deviation 13.15 |
| ITM + Bupivacaine QLB | Systolic Blood Pressure | 124.00 mmHg | Standard Deviation 5.66 |
Secondary
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 4-hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Systolic Blood Pressure | 113.69 mmHg | Standard Deviation 12.94 |
| ITM + Bupivacaine QLB | Systolic Blood Pressure | 116.21 mmHg | Standard Deviation 12.05 |
Secondary
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 4 hours after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Visual Analogue Scale (VAS) Pain Score at Rest | 3.5 units on a scale | Standard Deviation 2.77 |
| ITM + Bupivacaine QLB | Visual Analogue Scale (VAS) Pain Score at Rest | 1.36 units on a scale | Standard Deviation 1.65 |
Secondary
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 1 hour after intervention
Population: Data was not collected at the specified timepoint for this outcome.
Secondary
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 48 hours after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Visual Analogue Scale (VAS) Pain Score at Rest | 3.73 units on a scale | Standard Deviation 2.57 |
| ITM + Bupivacaine QLB | Visual Analogue Scale (VAS) Pain Score at Rest | 3.4 units on a scale | Standard Deviation 2.63 |
Secondary
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 24 hours after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITM + Sham QLB | Visual Analogue Scale (VAS) Pain Score at Rest | 3.14 units on a scale | Standard Deviation 1.83 |
| ITM + Bupivacaine QLB | Visual Analogue Scale (VAS) Pain Score at Rest | 2.38 units on a scale | Standard Deviation 2.14 |