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Improving ObsQoR-11 With Continuous Wound Infusion Versus Intrathecal Morphine After Elective Cesarean Delivery

NCT05696678 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-02-21

No results posted yet for this study

Summary

The purpose of this prospective randomized double-blinded and controlled study is to evaluate the quality of recovery after elective cesarean delivery using the Obstetric Quality-of-Recovery-11 (ObsQoR-11) score at 24 hours between patients receiving intrathecal morphine (ITM group) compared to patients receiving a ropivacaine continuous wound infusion (CWI group).

Conditions

  • Quality of Recovery
  • Anesthesia
  • Postoperative Pain
  • Cesarean Section

Interventions

DRUG

Intrathecal Morphine

Patient will receive a spinal anesthesia with a dose of 10.5 mg of bupivacaine 0.75% (1.4 ml),10 mcg of fentanyl (0.2 ml) and 100 mcg of morphine (0.2 ml) for cesarean delivery. At the end of surgery, at wound closure, a 19 Gauge 150 mm catheter will be placed under the fascia and will be linked to an elastometric pump filled with sterile saline (600 ml). A bolus of 20 ml will be administered, and an 8 ml/h infusion will be started. The catheter will be removed at 72 hours.

DRUG

Ropivacaine 0.2%

Patient will receive a spinal anesthesia with a dose of 10.5 mg of bupivacaine 0.75% (1.4 ml),10 mcg of fentanyl (0.2 ml) and 100 mcg of morphine (0.2 ml) for cesarean delivery. At the end of surgery, at wound closure, a 19 Gauge 150 mm catheter will be placed under the fascia and will be linked to an elastometric pump filled with sterile saline (600 ml). A bolus of 20 ml will be administered, and an 8 ml/h infusion will be started. The catheter will be removed at 72 hours.

Sponsors & Collaborators

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-08-31
Completion
2023-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696678 on ClinicalTrials.gov