Clinical trial NCT02279628: Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section
Official title: Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: cesarean section
spinal anesthesia
continuous wound infiltration
intrathecal morphine
oral morphine
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Maternite Regionale Universitaire
First posted: 2014-10-31
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Morphine consumption during the first 48 postoperative hours
timeFrame: at the 48th hour
Secondary outcomes:
measure: Pain at rest and at mobilization
timeFrame: Every 4 hours during the first 48 postoperative hours
measure: Time to restoration of bowel function
timeFrame: within the first 48 postoperative hours
measure: Verbal and Visual analog pain scores in the first standing position
timeFrame: at day 1
measure: Number of patients that required oral morphine
timeFrame: At the 24th and 48th hour
measure: Number of patients that required local anesthetic rescue dose through the catheter
timeFrame: At the 24th and 48th hour
measure: Postoperative rehabilitation survey
timeFrame: At the 48th hour
measure: Occurrence of side effect
timeFrame: During the first 48 hours
measure: Postoperative residual pain (DN4 survey)
timeFrame: At 3 months postoperatively
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternité Régionale Universitaire (MRU)
state: Lorraine
Study officials:
affiliation: Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
name: Hervé BOUAZIZ, MD., PhD.
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
name: Florence VIAL, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
name: Philippe GUERCI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.