Quadratus Lumborum Block vs Intrathecal Morphine for Post-Cesarean Analgesia

NCT06612424 | Completed

• 1 other identifier: GaziosmanpasaTREH-ITM
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Keywords

intratechal morphine; anterior quadratus lumborum block; cesarean delivery; postoperative pain

Outcome Measures

Primary Outcomes (1)

• comparing the amount of total analgesic use in the first 24 hours in patients

  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 Outcomes (3)

• 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

  24 hour

• To compare postoperative side effects such as nausea, vomiting, and itching.

  24 hour

• time to first rescue analgesic requirement.

  24 hour

Study Arms (3)

anterior quadratus lumborum block

ACTIVE COMPARATOR

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.

Drug: ANTERİOR QUADRATUS LUMBORUM BLOCK

intratechal morphine group

ACTIVE COMPARATOR

In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine.

Drug: İNTRATECHAL MORPHİNE GROUP

control group

NO INTERVENTION

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.

Interventions

ANTERİOR QUADRATUS LUMBORUM BLOCK DRUG

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.

anterior quadratus lumborum block

İNTRATECHAL MORPHİNE GROUP DRUG

In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine.

intratechal morphine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnancy women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital, Istanbul, 34000

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (2)

• Sharpe EE, Molitor RJ, Arendt KW, Torbenson VE, Olsen DA, Johnson RL, Schroeder DR, Jacob AK, Niesen AD, Sviggum HP. Intrathecal Morphine versus Intrathecal Hydromorphone for Analgesia after Cesarean Delivery: A Randomized Clinical Trial. Anesthesiology. 2020 Jun;132(6):1382-1391. doi: 10.1097/ALN.0000000000003283.

  PMID: 32251031 RESULT

• Hussain N, Brull R, Weaver T, Zhou M, Essandoh M, Abdallah FW. Postoperative Analgesic Effectiveness of Quadratus Lumborum Block for Cesarean Delivery under Spinal Anesthesia. Anesthesiology. 2021 Jan 1;134(1):72-87. doi: 10.1097/ALN.0000000000003611.

  PMID: 33206131 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Serpil Sehirlioglu

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: September 22, 2024
• Primary Completion: March 28, 2025
• Study Completion: April 1, 2025
• Last Updated: February 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)