Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

Post Caesarean Analgesia Clinical Trial

— Apcisaal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264821
• Other study ID #: Apcisaal 01
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2014
• Last updated: May 21, 2015
• Start date: February 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Post Caesarean Analgesia

Intervention

Drug:
• ropivacaine infiltration
wound infiltration
• intrathecal morphine
100 µg added to the spinal anaesthesia
• placebo
placebo in spinal anaesthesia and in wound infiltration

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire Brugmann	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Dr Madeleine Wilwerth

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Effective Analgesia	T0 until first request of morphine PCAIV	30 hours after spinal injection T0	Yes
Primary	Morphine Consumption	Morphine consumption with PCAIV	30 hours after spinal injection T0	Yes
Secondary	Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.	Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?	30 hours after spinal injection	Yes