Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

Study Overview
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Brief Summary
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The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.

Official Title
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Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

Conditions
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Morphine, Analgesics, Analgesics, Opioid, Peripheral Nervous System Agents

Intervention / Treatment
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* Drug: Saline
* Drug: Bupivacaine
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective or non-elective cesarean delivery on prior day pain scores >5/10 Exclusion Criteria: BMI >40 obstructive sleep apnea drug abuse chronic pain chronic opioid use abdominal surgeries other than cesarean delivery contraindications to neuraxial or regional anesthesia received general anesthesia or did not receive neuraxial morphine for cesarean delivery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Control<br>20 milliliters (mL) 0.9% saline on each side | Drug: Saline<br>* 0.9% saline on each side<br>|
| Experimental: Quadratus Lumborum Block<br>20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side | Drug: Bupivacaine<br>* 0.25% bupivacaine (50mg) on each side<br>Drug: Dexamethasone<br>* 3mg preservative-free dexamethasone on each side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption |  | 48 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of opioids used |  | at the time of intervention (one day following cesarean delivery) | 
| Amount of opioids used |  | 6 hours after intervention | 
| Amount of opioids used |  | 12 hours after intervention | 
| Amount of opioids used |  | 24 hours after intervention | 
| Amount of opioids used |  | 48 hours after intervention | 
| Time from quadratus lumborum block until first opioid request |  | from time of intervention until time of first opioid request (up to 48 hours) | 
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | at the time of intervention (one day following cesarean delivery) | 
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | at the time of intervention (one day following cesarean delivery) | 
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 6 hours after intervention | 
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 6 hours after intervention | 
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 12 hours after intervention | 
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 12 hours after intervention | 
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 24 hours after intervention | 
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 24 hours after intervention | 
| Pain as measured by an 11-point verbal pain score (at rest) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 48 hours after intervention | 
| Pain as measured by an 11-point verbal pain score (with movement) | The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain. | 48 hours after intervention | 
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | at the time of intervention (one day following cesarean delivery) | 
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 6 hours after intervention | 
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 12 hours after intervention | 
| Nausea, pruritus and sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 24 hours after intervention | 
| Nausea as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 48 hours after intervention | 
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | at the time of intervention (one day following cesarean delivery) | 
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 6 hours after intervention | 
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 12 hours after intervention | 
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 24 hours after intervention | 
| Pruritus as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 48 hours after intervention | 
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | at the time of intervention (one day following cesarean delivery) | 
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 6 hours after intervention | 
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 12 hours after intervention | 
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 24 hours after intervention | 
| Sedation as measured by a 3-point scale | This is measured categorically as none, mild, or moderate-severe. | 48 hours after intervention | 
| Patient satisfaction as measured by the 5-point Likert scale | The 5-point scale ranges from extremely satisfied to not satisfied. | 48 hours after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadratus lumborum block, bupivacaine, cesarean delivery, c-section, intrathecal morphine, post-operative pain, post-cesarean analgesia