Skip to main content
Clinical Trials/NCT06481462
NCT06481462
Completed
Not Applicable

Comparison of the Effects of Intrathecal Morphine and Ultrasound-Guided Bilateral Posterior Quadratus Lumborum Block on Postoperative Acute Pain in Cesarean Section: A Prospective, Observational Study

Ondokuz Mayıs University1 site in 1 country68 target enrollmentJuly 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Ondokuz Mayıs University
Enrollment
68
Locations
1
Primary Endpoint
Morphine consumption in the first 24 hours after surgery
Status
Completed
Last Updated
last year

Overview

Brief Summary

In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.

Detailed Description

Postoperative acute pain following a cesarean section is sharp, well-localized, and highly intense. An ideal pain management approach after a cesarean section should provide high-quality analgesia with minimal side effects and facilitate the mother's rapid return to daily activities. Different options for pain control include central blocks, peripheral blocks, and systemic medications. Intrathecal morphine (ITM) administration is a widely used approach for post-cesarean pain management both globally and in our clinic. However, it can reduce patient satisfaction due to side effects such as nausea, vomiting, and itching. On the other hand, the Quadratus Lumborum Block (QLB), a type of peripheral block, has proven analgesic efficacy in controlling acute postoperative pain following a cesarean section. The aim of this study is to examine and compare the analgesic efficacy of intrathecal morphine (ITM) and Posterior Quadratus Lumborum in the management of acute postoperative pain after a cesarean section. This study is a single-center, double-blind, prospective observational study. Patients will be divided into 2 groups. Group 1: The group receiving intrathecal morphine (ITM) Group 2: The group receiving Posterior Quadratus Lumborum Block In elective cesarean section cases under spinal anesthesia, the patient group receiving ITM and posterior QLB will be evaluated for obstetric general well-being during the first 24 hours and at discharge. Total morphine consumption in the first 24 hours, Pain scores (NRS) at rest and during movement, presence of nausea-vomiting and itching, patient satisfaction and any potential side effects will be recorded through follow-up.

Registry
clinicaltrials.gov
Start Date
July 3, 2024
End Date
December 26, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

BURHAN DOST

Doc. Dr

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • Pregnant for at least 37 weeks
  • Aged between 18 and 45
  • ASA (American Society of Anesthesiologists) physical status score II
  • Patient planned for elective cesarean section under spinal anesthesia
  • Patient receiving QLB-II block or intrathecal morphine

Exclusion Criteria

  • ASA score of III or IV.
  • Planned cesarean section under general anesthesia.
  • Requirement for conversion to general anesthesia after failed spinal anesthesia.
  • Contraindication to spinal anesthesia and regional anesthesia techniques.
  • BMI greater than 35 kg/m².
  • History of opioid use disorder or opioid use for more than 4 weeks.
  • Inability to assess pain scores.
  • Pregnancies of less than 37 weeks gestation.
  • History of allergy to local anesthetics and systemic opioids.
  • Patient refusal

Outcomes

Primary Outcomes

Morphine consumption in the first 24 hours after surgery

Time Frame: Postoperative day 1

Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 4

Secondary Outcomes

  • Postoperative nausea and vomiting (PONV) scores(Postoperative Day 1)
  • Postoperative pain scores(Postoperative day 1)
  • Postoperative pruritus score(Postoperative Day 1)
  • The number of patient required rescue analgesic(Postoperative Day 1)
  • Patients' satisfaction and quality of pain management(Postoperative Day 1)

Study Sites (1)

Loading locations...

Similar Trials