Lateral QL Block vs Intrathecal Morphine for Cesarean Section

ConditionsAnesthesia Postoperative Pain Regional Anesthesia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorOndokuz Mayıs University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Lateral Quadratus Lumborum Block
Procedure/Surgery
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.
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.
Intrathecal morphine
Procedure/Surgery
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.

Treatment groups

56 Participants

are divided into 2 treatment groups

Group A: Group QLBExperimental treatment 2 interventions

Group B: Group ITMExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

postoperative day 1

Secondary outcomes

Cumulative equivalent morphine consumption in the first 48 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 48 postoperative hours following surgery, will be converted to morphine milligram equivalents (MME) using validated conversion factors and summed.

Time frame

postoperative day 2

Other outcomes

Cumulative equivalent morphine consumption in the first 12 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 12 postoperative hours following surgery, will be converted to morphine milligram equivalents (MME) using validated conversion factors and summed.

Time frame

postoperative day 1

Postoperative pain scores

Pain status at rest and while activity will be assessed by NRS score at 0, 3, 6, 12, 24,36 and 48. hours after surgery. The NRS is an 11-point numeric scale that ranges from 0 to 10.

Time frame

postoperative day 2

area under the NRS score curve (AUC) for resting

area under the NRS score curve (AUC) for resting and active 48 hours after surgery

Time frame

postoperative day 2

Integrated Analgesic Score

Composite outcome integrating pain burden (AUC) and opioid consumption (IV-MME), expressed as the Integrated Analgesia Score (IAS), with lower scores indicating better overall analgesic efficacy.

Time frame

postoperative day 2

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ondokuz Mayıs University

Lead sponsor

Source ClinicalTrials.gov

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