Two Dose Epidural Morphine for Post-cesarean Analgesia

Columbia University

Status and phase

Terminated

Phase 4

Conditions

Morphine Adverse Reaction

Pain

Treatments

Drug: Epidural Saline

Drug: Epidural Morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT01844206

AAAL3857

Details and patient eligibility

About

The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

Full description

This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.

The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Enrollment

5 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women undergoing cesarean section under epidural anesthesia.

Exclusion criteria

Emergent cesarean section
Coagulopathy
Failed epidural anesthesia or patchy block
General anesthesia
Use of epidural chloroprocaine
Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
Severe opioid side effects
History of chronic opioid use
History of chronic pain
History of obstructive sleep apnea
Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
Height under 4' 10" (147 cm)
Documented dural puncture by the epidural (Tuohy) needle
Preeclampsia
Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).