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

NCT05696678 | Withdrawn

• 1 other identifier: 2023-3020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ObsQoR-11

Outcome Measures

Primary Outcomes (1)

• ObsQoR-11 at 24 hours

  Quality of recovery after cesarean delivery using ObsQoR-11 score at 24 hours between patients receiving intrathecal morphine (ITM) compared to patients receiving a ropivacaine continuous wound infusion CWI)

  24 hours after end of surgery

Secondary Outcomes (8)

• Global health score

  24, 48 and 72 hours after end of surgery

• ObsQoR-11 at 48 and 72 hours

  48 and 72 hours after end of surgery

• ObsQoR-11 items

  24, 48 and 72 hours after end of surgery

• Pain scores

  In postanesthesia care unit (PACU), at 2, 4, 6, 12, 24, 48, 72 hours and 5 and 7 days after the end of surgery

• Opioid consumption

  In postanesthesia care unit (PACU), at 2, 4, 6, 12, 24, 48, 72 hours and 5 and 7 days after the end of surgery

Study Arms (2)

Intrathecal Morphine (Control Group)

ACTIVE COMPARATOR

Spinal anesthesia with intrathecal morphine and postoperative continuous wound infusion with sterile saline.

Drug: Intrathecal Morphine

Continuous Wound Infusion (Intervention Group)

ACTIVE COMPARATOR

Spinal anesthesia without intrathecal morphine and postoperative continuous wound infusion with ropivacaine.

Drug: Ropivacaine 0.2%

Interventions

Intrathecal Morphine DRUG

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.

Intrathecal Morphine (Control Group)

Ropivacaine 0.2% DRUG

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.

Continuous Wound Infusion (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists status I and II
• Maternal age above 18 years' old
• Elective cesarean delivery
• Spinal anesthesia
• At least 37 weeks of gestational age
• French-speaking patients (able to read and sign the consent form)

You may not qualify if:

• Chronic pain
• Chronic usage of any opioids
• Cardiopathy
• Unexpected difficult spinal anesthesia requiring general anesthesia or unsatisfactory sensory blockade
• Unexpected complications requiring strong hemodynamic support (transfusions, volume challenges, multiple vasopressors, inotropic drugs…) or requiring anti-hypertensive medication (including magnesium)
• Any contraindication (e.g. coagulopathy) or patient's refusal for spinal anesthesia
• Morbid obesity (BMI \> 40 at the time of delivery)
• Active labour
• Emergency CD
• Fetal abnormality or prematurity (\< 37 weeks of gestational age)
• Multiple gestation
• Inability to cooperate due to language or physical/mental incapacity

Sponsors & Collaborators

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

Study Sites (1)

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the anesthesiologist in charge in the operating room will be aware of treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Principal Investigator, Anesthesiologist, Associate Professor, MD, PhD

Model Details: Randomized double-blinded and controlled study

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: January 25, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)