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 mobilizationTime 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
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