Quadratus Lumborum Block vs Intrathecal Morphine for Post-Cesarean Analgesia

February 3, 2026 updated by: SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital

Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum Block and Intrathecal Morphine Administration in Cesarean Deliveries

İn this study, planned to compare the post-operative analgesic efficacy of Intrathecal Morphine Administration and anterior Quadratus lumborum Block in elective cesarean section operations.

this study primary aim is; To compare the amount of total analgesic use in the first 24 hours in patients

Our secondary aims are: 1.) To compare and evaluate the first rescue analgesia requirement times 2.) To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 . 24. hours in the postoperative follow-up of the patients after anterior Quadratus lumborum block and Intrathecal morphine administration for postoperative analgesia after elective cesarean section operations under spinal anesthesia.

3.) Comparing the side effects such as postoperative nausea and vomiting

Study Overview

Detailed Description

Participants scheduled for elective cesarean sections under spinal anesthesia will be divided into three groups: anterior Quadratus Lumborum block (QLB), intrathecal morphine, and control groups, using the sealed-envelope randomization method. All participants will receive detailed information and provide informed consent. Anesthesia for all patients will be administered under spinal anesthesia. Spinal anesthesia will be performed with 12 mg of bupivacaine injected intrathecally at the L3-4 or L4-5 intervertebral space using a 25G spinocan needle.

In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine. In the QLB and control groups, intrathecal morphine will not be administered, and 0.1 mL of saline will be added to 12 mg of bupivacaine instead. In the anterior QLB block group, the block will be performed postoperatively. Participants in the QLB group will be taken at the end of the surgery.

All blocks will be performed by the same anesthesiologist using ultrasound guidance. In the Quadratus Lumborum block group, participants will be placed in the lateral decubitus position. A convex ultrasound probe will be placed in sterile conditions along the midaxillary line, in the subcostal area above the iliac crest, to visualize the quadratus lumborum and psoas major muscles, as well as the L4 vertebral transverse process. Using an in-plane technique, a 22G, 100 mm peripheral block needle will be advanced anterior to the quadratus lumborum muscle and into the subfascial space between the quadratus lumborum and psoas major muscles. After confirming the correct location with hydrodissection, 20 mL of 0.25% bupivacaine will be injected slowly, observing the fascial displacement on ultrasound. The same procedure will be repeated on the contralateral side. All patients will be monitored in PACU for 30 minutes post-procedure.

The control and intrathecal morphine groups will not receive any postoperative interventions. At the end of the surgery, once the modified Aldrete score is greater than 8, participants will be transferred to the ward due to the spinal anesthesia. Postoperatively, when the spinal anesthesia level recedes by two dermatomes, patients will receive 1g of intravenous paracetamol for analgesia. The postoperative analgesic regimen will include paracetamol 1g every 6 hours (4x1g). In participants with NRS (Numerical Rating Scale) scores greater than 3 during postoperative follow-up, 75 mg of intravenous diclofenac sodium will be administered as rescue analgesia in the ward. Diclofenac was not to be administered more than twice daily, and if the NRS score remained ≥4 despite two doses, intravenous tramadol at a dose of 1 mg/kg was planned.

Participants will be evaluated at 2, 4, 8, 12, and 24 hours postoperatively by a blinded anesthesiologist different from the one who performed the block. Resting and dynamic NRS scores (rated on a scale of 0-10, where 0 indicates no pain and 10 indicates the most severe pain; dynamic NRS scores will be assessed by asking the patient to cough) will be recorded, along with the total amount of analgesics used in the first 24 hours postoperatively, and the incidence of nausea, vomiting, and pruritus will also be evaluated.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey (Türkiye), 34255
        • Gaziosmanpasa Research and Education Hospital, Istanbul, 34000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Inclusion Criteria:

  • Participants aged between 18 and 40
  • ASA 2 risk group
  • Participants at 37-41 weeks of pregnancy
  • undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

  • The participant does not accept the procedure.
  • Patients with a history of eclampsia and preeclampsia during pregnancy
  • local anesthetic allergy
  • Infection at the procedure site
  • Anticoagulant use with bleeding disorder
  • Chronic analgesia and opioid use
  • Mental, psychiatric and neurological problems -Participant with ASA 3 and above with a history of any chronic disease. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intratechal morphine group
In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine.
In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine.
No Intervention: control group
Participants in the control group will not receive any interventions such as intrathecal morphine or quadratus lumborum block. They will undergo cesarean sections under spinal anesthesia.
Active Comparator: anterior quadratus lumborum block
All blocks will be performed by the same anesthesiologist using ultrasound guidance. In the Quadratus Lumborum block group, patients will be placed in the lateral decubitus position. A convex ultrasound probe will be placed in sterile conditions along the midaxillary line, in the subcostal area above the iliac crest, to visualize the quadratus lumborum and psoas major muscles, as well as the L4 vertebral transverse process. Using an in-plane technique, a 22G, 100 mm peripheral block needle will be advanced anterior to the quadratus lumborum muscle and into the subfascial space between the quadratus lumborum and psoas major muscles. After confirming the correct location with hydrodissection, 20 mL of 0.25% bupivacaine will be injected slowly, observing the fascial displacement on ultrasound. The same procedure will be repeated on the contralateral side.
In the Quadratus Lumborum block group, Participants will be placed in the lateral decubitus position. A convex ultrasound probe will be placed in sterile conditions along the midaxillary line, in the subcostal area above the iliac crest, to visualize the quadratus lumborum and psoas major muscles, as well as the L4 vertebral transverse process. Using an in-plane technique, a 22G, 100 mm peripheral block needle will be advanced anterior to the quadratus lumborum muscle and into the subfascial space between the quadratus lumborum and psoas major muscles. After confirming the correct location with hydrodissection, 20 mL of 0.25% bupivacaine will be injected slowly, observing the fascial displacement on ultrasound. The same procedure will be repeated on the contralateral side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparing the amount of total analgesic use in the first 24 hours in patients
Time Frame: 24 hour

For all Participants, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Participants with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with diclofenac sodium 75 mg at a dose intravenos.The total diklofenac sodium consumption of participants within the first 24 hours will be compared.

(At initial trial registration, postoperative NRS pain scores were specified as the primary outcome. During the study phase, total postoperative analgesic consumption was used as the primary outcome for statistical planning, analysis, and reporting.

The trial registration was updated to ensure consistency between registered outcomes and analyses. NRS pain scores were analyzed as secondary outcomes. This update was not based on study results.)

24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare postoperative side effects such as nausea, vomiting, and itching.
Time Frame: 24 hour
To compare postoperative side effects such as nausea, vomiting, and itching.
24 hour
time to first rescue analgesic requirement.
Time Frame: 24 hour
Comparison of the time to first rescue analgesic requirement.
24 hour
To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 . 24. hours in the postoperative follow-up of the patients
Time Frame: 24 hour
To compare the Numeric Rating Scale (NRS) values (at rest and with movement) of the patients during postoperative follow-ups at 2, 4, 8, 12, and 24 hours.Pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores reflect greater pain intensity.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Serpil Sehirlioglu, Gaziosmanpasa Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2024

Primary Completion (Actual)

March 28, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

September 21, 2024

First Submitted That Met QC Criteria

September 21, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If requested, it can be provided by contacting the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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