DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Central Hospital, Nancy, France
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Ropivacaine (Drug); Morphine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Central Hospital, Nancy, France

Official(s) and/or principal investigator(s):
Hervé BOUAZIZ, MD., PhD., Study Chair, Affiliation: Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Florence VIAL, MD., Principal Investigator, Affiliation: Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Philippe GUERCI, MD, Principal Investigator, Affiliation: Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE

Overall contact:
Florence VIAL, MD, Phone: + 33 3 83 34 43 67, Email: f.vial@maternite.chu-nancy.fr

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.

Clinical Details

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

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

Primary outcome: Morphine consumption during the first 48 postoperative hours

Secondary outcome:

Pain at rest and at mobilization

Time to restoration of bowel function

Verbal and Visual analog pain scores in the first standing position

Number of patients that required oral morphine

Number of patients that required local anesthetic rescue dose through the catheter

Postoperative rehabilitation survey

Occurrence of side effect

Postoperative residual pain (DN4 survey)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Florence VIAL, MD, Phone: + 33 3 83 34 43 67, Email: f.vial@maternite.chu-nancy.fr

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

Starting date: July 2014
Last updated: October 28, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017