Two Dose Epidural Morphine for Post-cesarean Analgesia

Pain Clinical Trial

Official title:

Two Dose Epidural Morphine for Post-cesarean Analgesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01844206
• Other study ID #: AAAL3857
• Status: Terminated
• Phase: Phase 4
• First received: April 29, 2013
• Last updated: November 19, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morphine Adverse Reaction
• Pain

Intervention

Drug:
• Epidural Morphine
Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
• Epidural Saline
Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery	The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.	Up to 48 hours post-operatively	No