Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block and External Oblique Intercostal Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: a Two-Center Randomized Controlled Trial
A Two-Center
A Two-Center Randomized Controlled Trial
1 other identifier
interventional
46
1 country
1
Brief Summary
The primary aim of this study was to compare the postoperative analgesic efficacy of the Anterior Quadratus Lumborum Plane Block and the External Oblique Intercostal Plane Blocks used in laparoscopic cholecystectomy surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
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
October 29, 2024
CompletedStudy Start
First participant enrolled
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedDecember 4, 2024
December 1, 2024
28 days
October 29, 2024
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Numeric Rating Scale
They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome
Postoperative 30.second,2 hours, 4 hours,12 hours,24 hours
Secondary Outcomes (3)
Opioid use
postoperative 24 hours
Riker Sedation Agitation Scale
Immediately after extubation
Patient satisfaction score
at the 24th postoperative hour
Study Arms (2)
Anterior Quadratus Lumborum Plane Block
ACTIVE COMPARATORAfter endotracheal intubation, patients in the supine position will be given a lateral tilt and the areas to be treated will be cleaned with surgical antiseptic solution. The convex USG probe will be covered in a sterile manner. Then, the sterile probe will be placed transversely on the crista iliaca. The probe will be directed cranially until the external oblique muscle, internal oblique muscle and transverse abdominis muscle are clearly visualized. The psoas major muscle and the transverse process of the vertebra will be visualized. The QL muscle will be visualized between the aponeuros of the transverse abdominis muscle and the psoas major muscle. A 20 G 100 mm block needle will be advanced from posterolateral to anteromedial using the "in-plane" technique. The needle will be directed between the QL muscle and the psoas major muscles. 20 ml of 0.25% bupivacaine (Buvasin®, Vem İlaç, Turkey) will be injected on each side between the fasciae of these two muscles and the LA distributio
External Oblique Intercostal Plane Block
ACTIVE COMPARATORAfter endotracheal intubation, a 20-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).
Interventions
After endotracheal intubation, patients in the supine position will be given a lateral tilt and the areas to be treated will be cleaned with surgical antiseptic solution. The convex USG probe will be covered in a sterile manner. Then, the sterile probe will be placed transversely on the crista iliaca. The probe will be directed cranially until the external oblique muscle, internal oblique muscle and transverse abdominis muscle are clearly visualized. The psoas major muscle and the transverse process of the vertebra will be visualized. The QL muscle will be visualized between the aponeuros of the transverse abdominis muscle and the psoas major muscle. A 20 G 100 mm block needle will be advanced from posterolateral to anteromedial using the "in-plane" technique. The needle will be directed between the QL muscle and the psoas major muscles. 20 ml of 0.25% bupivacaine (Buvasin®, Vem İlaç, Turkey) will be injected on each side between the fasciae of these two muscles and the LA distribution
After endotracheal intubation, a 20-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).
Eligibility Criteria
You may qualify if:
- Patients who will undergo laparoscopic cholecystectomy and who meet the ASA I-II risk classification between the ages of 18-65 will be included.
You may not qualify if:
- Patients who do not agree to participate in the study, who have an infection in the application area, who are allergic to local anesthesia, who have coagulopathy, who are morbidly obese (Body mass index (BMI)\>35), who have a history of drug allergy, chronic pain, long-term opioid use and psychiatric illness, and who require emergency surgery are excluded from the study. will be left
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Sciences University Gazi Yaşargil Training and Research Hospital
Diyarbakır, kayapınar, 21070, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiology and Reanimation Spesialist
Study Record Dates
First Submitted
October 29, 2024
First Posted
October 30, 2024
Study Start
October 29, 2024
Primary Completion
November 26, 2024
Study Completion
November 30, 2024
Last Updated
December 4, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share