Intrathecal Morphine vs. US-Guided Bilateral Posterior Quadratus Lumborum Block in Cesarean Section
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
1 other identifier
observational
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 1, 2024
CompletedStudy Start
First participant enrolled
July 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2024
CompletedFebruary 25, 2025
February 1, 2025
5 months
June 25, 2024
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphine consumption in the first 24 hours after surgery
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
Postoperative day 1
Secondary Outcomes (5)
Postoperative pain scores
Postoperative day 1
Postoperative nausea and vomiting (PONV) scores
Postoperative Day 1
The number of patient required rescue analgesic
Postoperative Day 1
Postoperative pruritus score
Postoperative Day 1
Patients' satisfaction and quality of pain management
Postoperative Day 1
Study Arms (2)
Intrathecal Morphine
A subarachnoid block will be performed by injecting morphine 100 mcg + 12.5 mg hyperbaric bupivacaine + 20 mcg fentanyl.
Posterior Quadratus Lumborum Block
Patients scheduled for elective cesarean section under spinal anesthesia will receive bilateral ultrasound-guided posterior quadratus lumborum block.
Interventions
morphine 100 mcg + 12.5 mg bupivacaine + 20 mcg fentanyl
12.5 mg bupivacaine + 20 mcg fentanyl bilateral QLB block (posterior tip 2) 25 cc 0.25% bupivacaine
Eligibility Criteria
The study population consisted of pregnant women who were at least 37 weeks gestational age, aged between 18 and 45 years, with an ASA (American Society of Anesthesiologists) physical status score of II, scheduled for elective cesarean section under spinal anesthesia between July 1, 2024, and October 20, 2024, and who received either a posterior quadratus lumborum block (QLB-II) or intrathecal morphine.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ondokuz Mayıs University
Samsun, Turkey (Türkiye)
Related Publications (3)
Salama ER. Ultrasound-guided bilateral quadratus lumborum block vs. intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled trial. Korean J Anesthesiol. 2020 Apr;73(2):121-128. doi: 10.4097/kja.d.18.00269. Epub 2019 Mar 8.
PMID: 30852882BACKGROUNDKrohg A, Ullensvang K, Rosseland LA, Langesaeter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648.
PMID: 29135590BACKGROUNDOzkan G, Kara U, Ince ME, Ozdemir O, Ulubay M, Senkal S. Validation of the Turkish version of the Obstetric Quality-of-Recovery score 11 (ObsQoR-11T) after cesarean delivery. Health Qual Life Outcomes. 2022 Nov 28;20(1):155. doi: 10.1186/s12955-022-02073-y.
PMID: 36443784BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Burhan DOST
Ondokuz Mayıs University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doc. Dr
Study Record Dates
First Submitted
June 25, 2024
First Posted
July 1, 2024
Study Start
July 3, 2024
Primary Completion
November 26, 2024
Study Completion
December 26, 2024
Last Updated
February 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share