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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Samsun, Turkey
- Ondokuz Mayıs University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Posterior Quadratus Lumborum Block
Patients scheduled for elective cesarean section under spinal anesthesia will receive bilateral ultrasound-guided posterior quadratus lumborum block.
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12.5 mg bupivacaine + 20 mcg fentanyl bilateral QLB block (posterior tip 2) 25 cc 0.25% bupivacaine
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Intrathecal Morphine
A subarachnoid block will be performed by injecting morphine 100 mcg + 12.5 mg hyperbaric bupivacaine + 20 mcg fentanyl.
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morphine 100 mcg + 12.5 mg bupivacaine + 20 mcg fentanyl
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine consumption in the first 24 hours after surgery
Time Frame: Postoperative day 1
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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
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Postoperative day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative pain scores
Time Frame: Postoperative day 1
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Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, and 24 hours after operation.The NRS is an 11-point numeric scale which ranges from 0 to 10.
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Postoperative day 1
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Postoperative nausea and vomiting (PONV) scores
Time Frame: Postoperative Day 1
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The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation.
If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required.
The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
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Postoperative Day 1
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The number of patient required rescue analgesic
Time Frame: Postoperative Day 1
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The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 18, and 24 hours after operation
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Postoperative Day 1
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Postoperative pruritus score
Time Frame: Postoperative Day 1
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Pruritus score: 0 = no pruritus; 1 = sensation of itching, but not scratching, just a rubbing sensation (mild); 2 = sensation of itching and scratching (moderate); 3 = sensation of pruritus, scratching, and requiring treatment (severe).
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Postoperative Day 1
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Patients' satisfaction and quality of pain management
Time Frame: Postoperative Day 1
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Patients' pain management satisfaction and quality will be evaluated using the QoR-11 score. ObsQoR-11 is an 11-item questionnaire that is used to evaluate the recovery of parturient women after elective CS. ObsQoR-11 is evaluated in terms of the degree of post-operative pain, nausea, vomiting, activity, baby care, hygiene,and emotional control. Each item was scored using an 11-point system, with minimum and maximum scores of 0 and 110, respectively. A high score reflects good recovery. QoR-11 Turkish Version will be used for assessment. |
Postoperative Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Burhan DOST, Ondokuz Mayıs University
Publications and helpful links
General Publications
- 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.
- Krohg 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. Erratum In: Anesth Analg. 2019 Jan;128(1):e18. doi: 10.1213/ANE.0000000000003904.
- Ozkan 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITMQLB27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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