Bupivacaine, Pain, Postoperative
Conditions
Keywords
cesarean delivery, liposomal bupivacaine, Exparel, bupivacaine, wound infiltration
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.
Interventions
DRUGBupivacaine
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.
DRUGLiposomal bupivacaine
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.
DRUGPlacebos
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.
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-Blind Study
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ASA I or II women with uncomplicated singleton pregnancies 2. ≥37 weeks gestation 3. ≥18 years old presenting 4. Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM). 5. Able to provide informed consent.
Exclusion criteria
1. Subject is not a candidate for a spinal anesthetic 2. Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc) 3. Subject is on chronic opioids. 4. Subject is an ASA class III or higher. 5. Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, 6. Subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Analgesia | Thru 24 hours | VAS pain intensity scores (at rest) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (LOS) | Thru 72 hours | Reduction in LOS |
| Time to first ambulation | Thru 72 hours | Time to ambulation |
| Breast feeding initiation | Thru 72 hours | Time to breast feeding initiation |
| Opioid use in the post-operative period | Thru 72 hours | Post-operative opioid consumption |
| Increased operative time | Thru 72 hours | Increased operative time for cesarean delivery |
| Pain control at 2 hours post-cesarean delivery | Thru 2 hours | VAS pain intensity at 2 hours |
| Wound Complication | 14days post-operatively | Wound complication |
| Sole breastfeeding | Thru 72 hours | Percentage of subjects solely breastfeeding at the time of discharge |
Countries
United States
Contacts
Primary ContactBrian M Fitzgerald, MD
Outcome results
None listed