Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

Postoperative Pain Clinical Trial

Official title:

Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02279628
• Other study ID #: 2012-004498-14
• Status: Recruiting
• Phase: Phase 4
• First received: October 16, 2014
• Last updated: October 28, 2014
• Start date: July 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2014
• Source: Central Hospital, Nancy, France
• Contact: Florence VIAL, MD
• Phone: + 33 3 83 34 43 67
• Email: f.vial[@]maternite.chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.

Description:

The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Elective Cesarean section

• Spinal anesthesia

• Singleton

• ASA ( Physical status score) 1 to 3

Exclusion Criteria:

• Age <18yrs

• BMI = 45 kg/m2 or weight < 45 kg

• Refusal to consent

• Urgent cesarean section

• Allergy to a medication used in the protocol

• Impaired hemostasis ou current infection

• Contra indication or failure of spinal anesthesia

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

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine
Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)
• Morphine
Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period

Locations

Country	Name	City	State
France	Maternité Régionale Universitaire (MRU)	Nancy	Lorraine

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Maternite Regionale Universitaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption during the first 48 postoperative hours		at the 48th hour	No
Secondary	Pain at rest and at mobilization	The pain at rest and at mobilization will be evaluated with both Visual Analog scale and Verbal pain scale. The patient should describe the worst pain felt during the previous 4 hours in a lying position and at mobilization	Every 4 hours during the first 48 postoperative hours	No
Secondary	Time to restoration of bowel function		within the first 48 postoperative hours	No
Secondary	Verbal and Visual analog pain scores in the first standing position		at day 1	No
Secondary	Number of patients that required oral morphine		At the 24th and 48th hour	No
Secondary	Number of patients that required local anesthetic rescue dose through the catheter		At the 24th and 48th hour	No
Secondary	Postoperative rehabilitation survey		At the 48th hour	No
Secondary	Occurrence of side effect	Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire	During the first 48 hours	Yes
Secondary	Postoperative residual pain (DN4 survey)		At 3 months postoperatively	No