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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | Subject will receive 20ml of normal saline infiltration |
|
| Plain Bupivacaine | Experimental | Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg) |
|
| Liposomal Bupivacaine | Experimental | Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participants will include ASA I or II women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian M Fitzgerald, MD | Contact | 210-916-8666 | brian.m.fitzgerald.mil@mail.mil |
| Name | Affiliation | Role |
|---|---|---|
| Brian M Fitzgerald, MD | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Recruiting | Fort Sam Houston | Texas | 78234 | United States |
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By request.
By request.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Parallel Assignment
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Double-Blind Study
|
| Liposomal bupivacaine | Drug | 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. |
|
|
| Placebos | Drug | 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. |
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |