Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery

Study Overview
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Brief Summary
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This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.

Detailed Description
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The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.

Official Title
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Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery

Conditions
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Pain, Postoperative, Anesthesia, Local, Opioid Use

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All scheduled Cesarean deliveries with intrathecal or epidural anesthesia Exclusion Criteria: Emergency Cesarean deliveries Multifetal gestation Subjects <18 years old Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners) Cesarean delivery with general anesthesia Known allergy or hypersensitivity to any of the study medications Subjects that can't comprehend the visual analog scale for quantitative pain assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Wound infiltration with a placebo | Drug: Placebo<br>* Injection of a placebo into the surgical wound<br>|
| Experimental: Bupivacaine<br>Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL | Drug: Bupivacaine<br>* Injection of bupivacaine into the surgical incision prior to its closure.<br>* Other names: Bupivacaine wound infiltration;|
| Experimental: Bupivacaine and Dexmedetomidine<br>Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution . | Drug: Bupivacaine<br>* Injection of bupivacaine into the surgical incision prior to its closure.<br>* Other names: Bupivacaine wound infiltration;Drug: Dexmedetomidine<br>* Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.<br>* Other names: Dexmedetomidine wound infiltration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of opioid free Cesarean deliveries | Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first rescue analgesia | Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered | 0 hour post-cesarean to time rescue analgeisa is administered] | 
| Total opioid consumption | Measure the subjects total opioid consumption for the total duration of the postoperative course. | 0-14 days | 
| Side effects/Adverse reactions | Measure any side effects/allergic reactions attributed to use of any of the study drugs. | 0-14 days | 
| Postoperative hospital stay | Measure the length of the post-operative hospital stay . | 0-14days | 
| Complications from procedures | Measure any complications associated with the wound infiltration procedure | 0-14 days | 
| Breast feeding capacity | Assess the subject's capacity to breast feed during the postoperative course | 0-14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound infiltration, Post Cesarean, Pain management, bupivacaine, dexmedetomidine, postoperative pain