Wound Infiltration of Liposomal Bupivacaine v Plain Bupivacaine for Post-Op Pain Control in Elective Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery.

Detailed Description
-----------------
Participants will include women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM). Exclusion criteria include patients: not receiving a spinal anesthetic, receiving a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural narcotics, intravenous narcotics, etc), on chronic opioids, American Society of Anesthesiologist (ASA) physical status class III or higher (Note: An ASA I patient is defined as a normal healthy patient, an ASA II patient is defined as a patient with mild systemic disease and any patient that with severe systemic disease or a disease that is incapacitating would be classified as an ASA III or higher) or those that have known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, and any subject with hepatic or renal impairment. A three-arm study will be used: (a) control group (placebo of normal saline) (b) plain bupivacaine group and (c) liposomal bupivacaine group. After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one of the three solutions will be infiltrated into the wound by the obstetrician team in a standardized fashion.

Official Title
-----------------
A Comparison of Post-Incisional Wound Infiltration of Liposomal Bupivacaine to Plain Bupivacaine for Post-Operative Pain Control in Elective Cesarean Delivery: A Randomized Double Blind Placebo Controlled Trial

Conditions
-----------------
Bupivacaine, Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Liposomal bupivacaine
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II women with uncomplicated singleton pregnancies ≥37 weeks gestation ≥18 years old presenting Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM). Able to provide informed consent. Exclusion Criteria: Subject is not a candidate for a spinal anesthetic Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc) Subject is on chronic opioids. Subject is an ASA class III or higher. Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, Subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline<br>Subject will receive 20ml of normal saline infiltration | Drug: Placebos<br>* After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of normal saline will be infiltrated into the wound by the obstetrician team in a standardized fashion.<br>|
| Experimental: Plain Bupivacaine<br>Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg) | Drug: Bupivacaine<br>* After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of bupivacaine 0.5% plain will be infiltrated into the wound by the obstetrician team in a standardized fashion.<br>|
| Experimental: Liposomal Bupivacaine<br>Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded | Drug: Liposomal bupivacaine<br>* After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one liposomal bupivacaine will be infiltrated into the wound by the obstetrician team in a standardized fashion.<br>* Other names: Exparel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Analgesia | VAS pain intensity scores (at rest) | Thru 24 hours | 
| Post-operative Analgesia | VAS pain intensity scores (at rest) | Thru 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use in the post-operative period | Post-operative opioid consumption | Thru 72 hours | 
| Length of Stay (LOS) | Reduction in LOS | Thru 72 hours | 
| Time to first ambulation | Time to ambulation | Thru 72 hours | 
| Breast feeding initiation | Time to breast feeding initiation | Thru 72 hours | 
| Sole breastfeeding | Percentage of subjects solely breastfeeding at the time of discharge | Thru 72 hours | 
| Increased operative time | Increased operative time for cesarean delivery | Thru 72 hours | 
| Pain control at 2 hours post-cesarean delivery | VAS pain intensity at 2 hours | Thru 2 hours | 
| Wound Complication | Wound complication | 14days post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean delivery, liposomal bupivacaine, Exparel, bupivacaine, wound infiltration