AnesthesiaNCT07712783
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
A study testing Lateral Quadratus Lumborum Block, ıv morphine PCA and Intrathecal morphine in people with Anesthesia and Postoperative Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia, Postoperative Pain, Regional Anesthesia
- What is being tested?
- Lateral Quadratus Lumborum Block, ıv morphine PCA and Intrathecal morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Inadequate spinal anesthesia or the requirement for supplemental intraoperative analgesia.
- Surgical duration exceeding 120 minutes.
- Excessive intraoperative blood loss (≥1,000 mL) or the need for blood transfusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Analgesic Efficacy of Lateral Quadratus Lumborum Block and Intrathecal Morphine for Postoperative Pain Management Following Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled 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.
Read the detailed description
Effective postoperative analgesia following cesarean delivery is essential not only for improving maternal comfort but also for facilitating early mobilization, breastfeeding, and maternal-infant bonding. Inadequate pain control has been associated with delayed mobilization, pulmonary complications, postpartum depression, and the development of chronic postsurgical pain (CPSP).
Intrathecal morphine (ITM) has long been regarded as the gold standard for post-cesarean analgesia, providing effective pain relief for 18-24 hours after a single dose. However, its use is limited by opioid-related adverse effects, including pruritus, postoperative nausea and vomiting (PONV), sedation, and urinary retention. These adverse effects may reduce maternal satisfaction and negatively affect breastfeeding and early mobilization.
In recent years, quadratus lumborum block (QLB) has emerged as an effective alternative for postoperative analgesia in abdominal surgery. Among the various QLB approaches, the lateral QLB-I technique has attracted considerable interest because of its ease of ultrasound-guided application, low incidence of motor block, and potential to provide extensive visceral and somatic analgesia. Previous studies have demonstrated that QLB can effectively attenuate both somatic and visceral pain, with cranial spread of local anesthetic along the thoracolumbar fascia reaching the ventral rami of the thoracic nerves (Blanco, 2015; Elsharkawy, 2019).
Randomized controlled trials in patients undergoing cesarean delivery have shown that QLB reduces postoperative opioid consumption, lowers pain scores, and improves patient satisfaction compared with control groups (Salama, 2020; Zhu, 2021). However, studies directly comparing QLB with ITM remain limited. Current evidence suggests that the analgesic efficacy of QLB may be comparable to that of ITM, although robust evidence demonstrating non-inferiority is still lacking.
Compared with ITM, the principal advantages of lateral QLB include the absence of motor blockade, the potential to reduce opioid-related adverse effects, and facilitation of early mobilization. Although ITM provides potent analgesia, demonstrating that the analgesic efficacy of lateral QLB is clinically equivalent within a non-inferiority margin not exceeding 10 mg intravenous morphine milligram equivalents (IV-MME) would represent a clinically acceptable outcome in terms of patient comfort and safety.
Accordingly, the primary objective of this study is to determine whether lateral QLB-I provides non-inferior postoperative analgesia compared with ITM. Secondary objectives include a comprehensive evaluation of adverse effects, quality of recovery using the ObsQoR-11T, and postoperative opioid consumption.
- Conditions
- Anesthesia, Postoperative Pain, Regional Anesthesia
- Being tested
- Lateral Quadratus Lumborum Block, ıv morphine PCA, Intrathecal morphine
- Keywords
- cesarean delivery, postoperative opioid consumption, postoperative pain, lateral quadratus lumborum block, intrathecal morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Quadratus Lumborum BlockProcedure or surgery
Also called Lateral QLB
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 PCADrug
Also called PCA
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 morphineProcedure or surgery
Also called ITM
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.
| Study group | Role | What they receive |
|---|---|---|
| Group QLB | Experimental | LQLB (Active) + Sham ITM Receives: Procedure: Lateral Quadratus Lumborum Block; Drug: ıv morphine PCA |
| Group ITM | Experimental | ITM (Active) + Sham QLB Receives: Drug: ıv morphine PCA; Procedure: Intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 1
Secondary outcomes (1)
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.
Measured: postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)'.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURHAN DOST, Ondokuz Mayıs University
- Investigators
- Burhan Dost, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712783
- Sponsor's protocol ID
- VLQLBITM1
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Efficacy of Lateral Quadratus Lumborum Block and Intrathecal Morphine for Postoperative Pain Management Following Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07712783
- Acronym / sponsor ID
- VLQLBITM1
- Conditions
- Anesthesia, Postoperative Pain, Regional Anesthesia
- Keywords
- cesarean delivery, postoperative opioid consumption, postoperative pain, lateral quadratus lumborum block, intrathecal morphine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Effective postoperative analgesia following cesarean delivery is essential not only for improving maternal comfort but also for facilitating early mobilization, breastfeeding, and maternal-infant bonding. Inadequate pain control has been associated with delayed mobilization, pulmonary complications, postpartum depression, and the development of chronic postsurgical pain (CPSP).
Intrathecal morphine (ITM) has long been regarded as the gold standard for post-cesarean analgesia, providing effective pain relief for 18-24 hours after a single dose. However, its use is limited by opioid-related adverse effects, including pruritus, postoperative nausea and vomiting (PONV), sedation, and urinary retention. These adverse effects may reduce maternal satisfaction and negatively affect breastfeeding and early mobilization.
In recent years, quadratus lumborum block (QLB) has emerged as an effective alternative for postoperative analgesia in abdominal surgery. Among the various QLB approaches, the lateral QLB-I technique has attracted considerable interest because of its ease of ultrasound-guided application, low incidence of motor block, and potential to provide extensive visceral and somatic analgesia. Previous studies have demonstrated that QLB can effectively attenuate both somatic and visceral pain, with cranial spread of local anesthetic along the thoracolumbar fascia reaching the ventral rami of the thoracic nerves (Blanco, 2015; Elsharkawy, 2019).
Randomized controlled trials in patients undergoing cesarean delivery have shown that QLB reduces postoperative opioid consumption, lowers pain scores, and improves patient satisfaction compared with control groups (Salama, 2020; Zhu, 2021). However, studies directly comparing QLB with ITM remain limited. Current evidence suggests that the analgesic efficacy of QLB may be comparable to that of ITM, although robust evidence demonstrating non-inferiority is still lacking.
Compared with ITM, the principal advantages of lateral QLB include the absence of motor blockade, the potential to reduce opioid-related adverse effects, and facilitation of early mobilization. Although ITM provides potent analgesia, demonstrating that the analgesic efficacy of lateral QLB is clinically equivalent within a non-inferiority margin not exceeding 10 mg intravenous morphine milligram equivalents (IV-MME) would represent a clinically acceptable outcome in terms of patient comfort and safety.
Accordingly, the primary objective of this study is to determine whether lateral QLB-I provides non-inferior postoperative analgesia compared with ITM. Secondary objectives include a comprehensive evaluation of adverse effects, quality of recovery using the ObsQoR-11T, and postoperative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)'.
| Arm | Type | Receives |
|---|---|---|
| Group QLB | Experimental | Procedure: Lateral Quadratus Lumborum Block, Drug: ıv morphine PCALQLB (Active) + Sham ITM |
| Group ITM | Experimental | Drug: ıv morphine PCA, Procedure: Intrathecal morphineITM (Active) + Sham QLB |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral Quadratus Lumborum BlockAlso: Lateral QLBActive 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. | Procedure or surgery | Group QLB |
| ıv morphine PCAAlso: PCAA 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. | Drug | Group ITM, Group QLB |
| Intrathecal morphineAlso: ITMHyperbaric 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. | Procedure or surgery | Group ITM |
Primary outcome
Cumulative equivalent morphine consumption in the first 24 hours after surgery
Time frame: postoperative day 1
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.
1 secondary outcome
Cumulative equivalent morphine consumption in the first 48 hours after surgery
Time frame: postoperative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Burhan Dost principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Quadratus Lumborum Block, ıv morphine PCA and Intrathecal morphine in people with Anesthesia and Postoperative Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burhan Dost (+903623121919, burhandost@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative equivalent morphine consumption in the first 24 hours after surgery (time frame: postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.