NCT06481462

Brief Summary

In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

June 25, 2024

Last Update Submit

February 21, 2025

Conditions

Keywords

Cesarean sectionintrathecal morphineposterior quadratus lumborum block

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption in the first 24 hours after surgery

    Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 4

    Postoperative day 1

Secondary Outcomes (5)

  • Postoperative pain scores

    Postoperative day 1

  • Postoperative nausea and vomiting (PONV) scores

    Postoperative Day 1

  • The number of patient required rescue analgesic

    Postoperative Day 1

  • Postoperative pruritus score

    Postoperative Day 1

  • Patients' satisfaction and quality of pain management

    Postoperative Day 1

Study Arms (2)

Intrathecal Morphine

A subarachnoid block will be performed by injecting morphine 100 mcg + 12.5 mg hyperbaric bupivacaine + 20 mcg fentanyl.

Procedure: Intrathecal Morphine (ITM)

Posterior Quadratus Lumborum Block

Patients scheduled for elective cesarean section under spinal anesthesia will receive bilateral ultrasound-guided posterior quadratus lumborum block.

Procedure: Quadratus Lumborum II (QLB-II) Block

Interventions

morphine 100 mcg + 12.5 mg bupivacaine + 20 mcg fentanyl

Intrathecal Morphine

12.5 mg bupivacaine + 20 mcg fentanyl bilateral QLB block (posterior tip 2) 25 cc 0.25% bupivacaine

Posterior Quadratus Lumborum Block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients scheduled for cesarean section at ≥37 weeks of gestation.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population consisted of pregnant women who were at least 37 weeks gestational age, aged between 18 and 45 years, with an ASA (American Society of Anesthesiologists) physical status score of II, scheduled for elective cesarean section under spinal anesthesia between July 1, 2024, and October 20, 2024, and who received either a posterior quadratus lumborum block (QLB-II) or intrathecal morphine.

You may qualify if:

  • Pregnant for at least 37 weeks
  • Aged between 18 and 45
  • ASA (American Society of Anesthesiologists) physical status score II
  • Patient planned for elective cesarean section under spinal anesthesia
  • Patient receiving QLB-II block or intrathecal morphine

You may not qualify if:

  • ASA score of III or IV.
  • Planned cesarean section under general anesthesia.
  • Requirement for conversion to general anesthesia after failed spinal anesthesia.
  • Contraindication to spinal anesthesia and regional anesthesia techniques.
  • BMI greater than 35 kg/m².
  • History of opioid use disorder or opioid use for more than 4 weeks.
  • Inability to assess pain scores.
  • Pregnancies of less than 37 weeks gestation.
  • History of allergy to local anesthetics and systemic opioids.
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

Related Publications (3)

  • Salama ER. Ultrasound-guided bilateral quadratus lumborum block vs. intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled trial. Korean J Anesthesiol. 2020 Apr;73(2):121-128. doi: 10.4097/kja.d.18.00269. Epub 2019 Mar 8.

    PMID: 30852882BACKGROUND
  • Krohg A, Ullensvang K, Rosseland LA, Langesaeter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648.

    PMID: 29135590BACKGROUND
  • Ozkan G, Kara U, Ince ME, Ozdemir O, Ulubay M, Senkal S. Validation of the Turkish version of the Obstetric Quality-of-Recovery score 11 (ObsQoR-11T) after cesarean delivery. Health Qual Life Outcomes. 2022 Nov 28;20(1):155. doi: 10.1186/s12955-022-02073-y.

    PMID: 36443784BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Burhan DOST

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doc. Dr

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

July 3, 2024

Primary Completion

November 26, 2024

Study Completion

December 26, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations