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Completed

NCT Number: NCT06666231

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, kayapınar, 21070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who will undergo laparoscopic cholecystectomy and who meet the ASA I-II risk classification between the ages of 18-65 will be included.

Exclusion criteria

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

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Treatment and study plan

QL (quadratus lumborum) block administration

Procedure

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

External Oblique Intercostal Plane Block

Procedure

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).

Primary outcomes

  1. Numeric Rating Scale

    Time frame: Postoperative 30.second,2 hours, 4 hours,12 hours,24 hours

    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

Secondary outcomes

  1. Opioid use

    Time frame: postoperative 24 hours

    tramadol use

  2. Riker Sedation Agitation Scale

    Time frame: Immediately after extubation

    7 Dangerous Agitation ... 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.

  3. Patient satisfaction score

    Time frame: at the 24th postoperative hour

    Patients' satisfaction with the quality of pain management will be evaluated on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = highly dissatisfied; 3 = medium; 4 = very satisfactory; 5 = very satisfactory

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

A Two-Center Randomized Controlled Trial

Acronym: A Two-Center

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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