Lateral QL Block vs Intrathecal Morphine for Cesarean Section

NCT07712783 | Not Yet Recruiting

• 1 other identifier: VLQLBITM1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Effective postoperative analgesia after cesarean delivery is essential for maternal recovery, early mobilization, breastfeeding, and maternal-infant bonding. Although intrathecal morphine (ITM) is considered the gold standard for post-cesarean analgesia, its use is associated with opioid-related adverse effects. Ultrasound-guided lateral quadratus lumborum block (QLB-I) has emerged as a promising alternative. This randomized, double-blind, non-inferiority trial aims to compare the postoperative analgesic efficacy of lateral QLB-I with ITM. Secondary outcomes include postoperative opioid consumption, pain scores, opioid-related adverse effects, quality of recovery (ObsQoR-11T), and maternal satisfaction.

Conditions

Anesthesia; Postoperative Pain; Regional Anesthesia

Keywords

cesarean delivery; postoperative opioid consumption; postoperative pain; lateral quadratus lumborum block; intrathecal morphine

Outcome Measures

Primary Outcomes (1)

• Cumulative equivalent morphine consumption in the first 24 hours after surgery

  The total dose of morphine administered via the patient-controlled analgesia (PCA) device, together with all rescue opioids administered during the first 24 postoperative hours following surgery, will be converted to morphine milligram equivalents (MME) using validated conversion factors and summed.

  postoperative day 1

Secondary Outcomes (1)

• Cumulative equivalent morphine consumption in the first 48 hours after surgery

  postoperative day 2

Other Outcomes (16)

• Cumulative equivalent morphine consumption in the first 12 hours after surgery

  postoperative day 1

• Postoperative pain scores

  postoperative day 2

• area under the NRS score curve (AUC) for resting

  postoperative day 2

Study Arms (2)

Group QLB

EXPERIMENTAL

LQLB (Active) + Sham ITM

Procedure: Lateral Quadratus Lumborum Block; Drug: ıv morphine PCA

Group ITM

EXPERIMENTAL

ITM (Active) + Sham QLB

Drug: ıv morphine PCA; Procedure: Intrathecal morphine

Interventions

Intrathecal morphine PROCEDURE

Hyperbaric 0.5% bupivacaine 12.5 mg, fentanyl 20 µg, and morphine 80 µg (0.08 mg). Spinal anesthesia will be performed at the L3-L4 or L4-L5 intervertebral space using a 25-gauge Quincke spinal needle. The study solution will be prepared to a total volume of 2.7 mL. Sham QLB Following completion of surgery, the patient will be positioned in the lateral decubitus position. The ultrasound transducer will be placed over the lateral QLB scanning window. A 22-gauge needle will be advanced into the skin and subcutaneous tissue only, without entering the fascial plane. To maintain procedural standardization and preserve blinding, 1-2 mL of normal saline will be injected into the subcutaneous tissue. Procedure duration, patient positioning, ultrasound probe placement, and dressing application will be identical to those used for the active lateral QLB-I procedure. A sterile dressing will be applied at the end of the procedure.

Also known as: ITM

Group ITM

ıv morphine PCA DRUG

A standardized IV PCA protocol will be initiated for all patients using a PCA device (Body Guard 575 pain manager, UK), programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum dose of 0.1-0.15 mg/ kg (IBW). No basal infusion will be used.

Also known as: PCA

Group ITM; Group QLB

Lateral Quadratus Lumborum Block PROCEDURE

Active Lateral QLB Local anesthetic: 0.25% bupivacaine, 0.4 mL/kg perside (maximum 30 mL per side). Maximum total dose: Bupivacaine ≤2.5 mg/kg (maximum approximately 150 mg). Timing: Immediately after completion of surgery. The patient will be positioned supine or in a slight lateral decubitus position. A high-frequency linear US transducer (5-12 MHz) will be placed on the anterolateral abdominal wall at the T12-L1 level. The fascial plane will be identified under ultrasound guidance. A 22-gauge, 100-mm needle will be advanced using an in-plane approach, and after negative aspiration, the local anesthetic will be injected incrementally with hydrodissection confirming correct spread. Sham ITM: The spinal anesthesia technique will be identical to that of the active ITM group. Morphine will be replaced with 0.2 mL preservative-free normal saline, while maintaining an identical syringe volume (2.7 mL) and appearance.

Also known as: Lateral QLB

Group QLB

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women aged between 18 and 45 years.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 18 and 45 years.
• Singleton term pregnancy (≥37 weeks of gestation).
• American Society of Anesthesiologists (ASA) physical status II.
• Scheduled to undergo elective cesarean delivery via a Pfannenstiel incision.
• Planned to receive spinal anesthesia for cesarean delivery.
• Provision of written informed consent following a comprehensive explanation of the study.
• Sufficient cognitive capacity to understand and complete the study assessment instruments, including the Numeric Rating Scale (NRS) and the ObsQoR-11T.

You may not qualify if:

• Known allergy or hypersensitivity to any of the study medications, including morphine, bupivacaine, or fentanyl.
• Coagulopathy (international normalized ratio \[INR\] \>1.5 or platelet count \<100,000/mm³).
• Current treatment with anticoagulant or antiplatelet agents (e.g., heparin, low-molecular-weight heparin, or aspirin \>100 mg/day).
• Infection, hematoma, or skin lesion at the planned block insertion site.
• Diagnosis of preeclampsia, eclampsia, or HELLP syndrome.
• Placenta previa, placenta accreta spectrum, or placental abruption.
• Gestational diabetes mellitus or chronic hypertension.
• Emergency cesarean delivery indicated because of fetal distress.
• Conversion to general anesthesia during cesarean delivery.
• History of chronic pain syndrome (e.g., fibromyalgia, lumbar disc herniation, or neuropathic pain).
• Regular use of opioids or psychotropic medications within the preceding 3 months.
• Diagnosis of epilepsy, severe anxiety disorder, or major depressive disorder.
• Obesity (body mass index \>35 kg/m²).
• Severe systemic disease, including New York Heart Association (NYHA) class III or IV heart failure, hepatic or renal failure, advanced respiratory disease, or obstructive sleep apnea.
• Advanced pulmonary disease requiring continuous positive airway pressure (CPAP) therapy.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Burhan Dost

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burhan Dost

CONTACT

+903623121919; burhandost@hotmail.com

Esra Turunc

CONTACT

+903623121919; esra.kiymaz.ek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned in a 1:1 ratio to one of two study groups (lateral QLB-I or ITM). The randomization sequence will be generated by an independent physician using the Research Randomizer web-based application with a block randomization scheme employing a fixed block size of four. Group allocations will be placed in sequentially numbered, opaque, sealed envelopes identified only by the participant's randomization number. The envelopes will be stored in a locked cabinet and opened on the day of surgery by an anesthesia nurse who is not otherwise involved in the randomization process or study conduct. All study personnel, including the participant, surgeons, and outcome assessors, will remain blinded to treatment allocation; only the anesthesiologist administering the spinal anesthesia will be aware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 17, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

TU (1)