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Completed

NCT Number: NCT02264821

Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.

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Key information

Conditions

Post Caesarean Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Universitaire Brugmann

Brussels, 1020, Belgium

About this study

Double blind, 3 groups

  • Control group: Rachi 0,1 ml saline, Infusion 300ml saline
  • Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
  • Group KT: 0,1 ml saline/300 ml naropin 0.2%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.

Exclusion criteria

  • Refusal of the patient or contra-indication to locoregional anesthesia
  • Allergy to the products used
  • ASA 3
  • ASA 4
  • Sleep apnea syndrome and/or obesity (BMI > 35)
  • Size inferior to 155cm
  • existence of a language barrier

Treatment and study plan

ropivacaine infiltration

Drug

wound infiltration

Other names: Naropin, local anesthetic

Intrathecal morphine

Drug

100 µg added to the spinal anaesthesia

Other names: spinal morphine

Placebo

Drug

placebo in spinal anaesthesia and in wound infiltration

Other names: Nacl 0,9 %, saline solution

Primary outcomes

  1. Duration of Effective Analgesia

    Time frame: 30 hours after spinal injection T0

    T0 until first request of morphine PCAIV

  2. Morphine Consumption

    Time frame: 30 hours after spinal injection T0

    Morphine consumption with PCAIV

Secondary outcomes

  1. Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.

    Time frame: 30 hours after spinal injection

    Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?

Sponsors and collaborators

Lead sponsor

Dr Madeleine Wilwerth

Other

Registry information

Official study title

Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study

Acronym: Apcisaal

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 15, 2014
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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