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

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Morphine

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Florence VIAL, MD; Phone Number: + 33 3 83 34 43 67; Email: f.vial@maternite.chu-nancy.fr
• Study Contact Backup: Name: Philippe GUERCI, MD; Phone Number: +33 3 83 15 73 99; Email: p.guerci@chu-nancy.fr

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54000
      • Recruiting
      • Maternité Régionale Universitaire (MRU)
      • Contact: Florence VIAL, MD; Phone Number: +33 3 83 34 44 67; Email: f.vial@maternite.chu-nancy.fr
      • Contact: Hervé BOUAZIZ, MD., PhD.; Phone Number: +33 3 83 34 44 67; Email: h.bouaziz@chu-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous wound infiltration alone; Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.	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)
Active Comparator: Intrathecal moprhine alone; Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter.	Drug: Morphine; Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period
Experimental: Intrathecal morphine&wound infiltration; Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.	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); Drug: Morphine; Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine consumption during the first 48 postoperative hours	at the 48th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to restoration of bowel function		within the first 48 postoperative hours
Verbal and Visual analog pain scores in the first standing position		at day 1
Number of patients that required oral morphine		At the 24th and 48th hour
Number of patients that required local anesthetic rescue dose through the catheter		At the 24th and 48th hour
Postoperative rehabilitation survey		At the 48th hour
Occurrence of side effect	Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire	During the first 48 hours
Postoperative residual pain (DN4 survey)		At 3 months postoperatively

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Maternite Regionale Universitaire
• Investigators: Study Chair: Hervé BOUAZIZ, MD., PhD., Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE; Principal Investigator: Florence VIAL, MD., Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE; Principal Investigator: Philippe GUERCI, MD, Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE

Publications and helpful links

General Publications

• Viviand C, Pietretti E, Luc A, Herbain D, Baka N, Morel O, Feugeas J, Aron C, Bouaziz H, Guerci P, Vial F. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anaesth. 2022 Jun;69(6):788-789. doi: 10.1007/s12630-022-02223-2. Epub 2022 Mar 10.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: cesarean section; spinal anesthesia; oral morphine; intrathecal morphine; continuous wound infiltration
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: 2012-004498-14