Clinical trial NCT01844206: Two Dose Epidural Morphine for Post-cesarean Analgesia
Official title: Two Dose Epidural Morphine for Post-cesarean Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Morphine Adverse Reaction
Keywords: Post-cesarean analgesia
Second dose of epidural morphine after surgery
Post-operative analgesia
Self-administered epidural morphine
Pain management after cesarean
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery
timeFrame: Up to 48 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Allison Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x.
citation: Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.