NCT06666231

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

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

28 days

First QC Date

October 29, 2024

Last Update Submit

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 COMPARATOR

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 distributio

Procedure: QL (quadratus lumborum) block administration

External Oblique Intercostal Plane Block

ACTIVE COMPARATOR

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).

Procedure: External Oblique Intercostal Plane Block

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

Anterior Quadratus Lumborum Plane Block

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).

External Oblique Intercostal Plane Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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

Locations