Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo

NCT04887649 | Completed Phase 3

• 1 other identifier: 7245408
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the analgesic effect of two different doses of epidural morphine for postpartum analgesia management. Previous studies have shown that conventional management of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is wasted using the epidural catheter is placed as part of the analgesic management of pregnant women in labor.

Conditions

Labor Pain

Keywords

Epidural opioid; Morphine; Postpartum pain; Analgesia; Perineorraphy

Outcome Measures

Primary Outcomes (1)

• The analgesic efficacy: : pain intensity rating

  The analgesic efficacy at controlling pain after delivery

  The first 24 hours after administration

Secondary Outcomes (1)

• the incidence of side effects

  the first 24 hours after administration

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients en treatment whit placebo, salIne solution in peridural cateter

Drug: saline solution

Morphine

ACTIVE COMPARATOR

Epidural Catheter morphine 2mg

Drug: Morphine

morphine

ACTIVE COMPARATOR

Epidurla cateter morphine 3 mg

Drug: Morphine

Interventions

Morphine DRUG

morphine 3 mg

Also known as: Random code numbers

Morphine; morphine

saline solution DRUG

4 cc of saline solution in epidural cateter in postpartum

Also known as: Random code numbers

Placebo

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients postpartum vaginal conventional analgesia management of your labor
• ASA II
• Do not include patients with history of allergy to morphine.
• Patients who agreed to be included in the study but did not sign informed consent.

You may not qualify if:

• Submit a complication that makes it difficult postoperative pain assessment or adverse effects after surgery.
• Patients who, after having been included, express their desire to be excluded. Patients with incomplete follow-up.id
• Did not include patients who have absolute contraindications for epidural anesthesia, or could not provide informed consent, as in the following cases: local infection at the site of administration, systemic infection, bleeding disorders, disease of the spine , mental patients, drug history, sleep apnea, history of headache post-puncture headache or frequent any kind.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Universidad Nacional; Maternal and Child Institute

Bogotá, Colombia

Location

Related Publications (10)

• Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979 Feb;50(2):149-51. doi: 10.1097/00000542-197902000-00013. No abstract available.

  PMID: 373503 BACKGROUND

• Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.

  PMID: 15507941 BACKGROUND

• Macarthur A, Imarengiaye C, Tureanu L, Downey K. A randomized, double-blind, placebo-controlled trial of epidural morphine analgesia after vaginal delivery. Anesth Analg. 2010 Jan 1;110(1):159-64. doi: 10.1213/ANE.0b013e3181c30f78. Epub 2009 Nov 12.

  PMID: 19910627 BACKGROUND

• Goodman SR, Drachenberg AM, Johnson SA, Negron MA, Kim-Lo SH, Smiley RM. Decreased postpartum use of oral pain medication after a single dose of epidural morphine. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):134-9. doi: 10.1016/j.rapm.2004.11.010.

  PMID: 15765455 BACKGROUND

• Behar M, Magora F, Olshwang D, Davidson JT. Epidural morphine in treatment of pain. Lancet. 1979 Mar 10;1(8115):527-9. doi: 10.1016/s0140-6736(79)90947-4.

  PMID: 85109 BACKGROUND

• Davies GK, Tolhurst-Cleaver CL, James TL. Respiratory depression after intrathecal narcotics. Anaesthesia. 1980 Nov;35(11):1080-3. doi: 10.1111/j.1365-2044.1980.tb05047.x.

  PMID: 6893789 BACKGROUND

• Soni AK, Miller CG, Pratt SD, Hess PE, Oriol NE, Sarna MC. Low dose intrathecal ropivacaine with or without sufentanil provides effective analgesia and does not impair motor strength during labour: a pilot study. Can J Anaesth. 2001 Jul-Aug;48(7):677-80. doi: 10.1007/BF03016202.

  PMID: 11495875 BACKGROUND

• Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.

  PMID: 18713913 BACKGROUND

• Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40. doi: 10.1007/BF03006481.

  PMID: 2208533 BACKGROUND

• Darío José PS, Ricardo N, Pedro H, Viviana C, Andrea G, Andrés G et al . Randomized double-blind controlled clinical trial for the evaluation of post-partum analgesia using epidural morphine: analgesic effectiveness of different dose regimes compared with placebo. Rev. colomb. anestesiol. 2012 Apr [cited 2021 May 04] ; 40( 1 ): 8-13. Available from: http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0120-33472012000100004&lng=en. https://doi.org/10.1016/S0120-3347(12)70004-7.

  RESULT

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Morphine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dario J Perea, Medical

  Universidad Nacional de Colombia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: May 14, 2021
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2011
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

CO (1)