External Oblique Plane Block and Subcostal Tap Block for Laparoscopic Cholecystectomy

NCT07061262 | Completed

• 1 other identifier: 266-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the efficacy of the external oblique plane block and the subcostal plane block in providing pain relief during perioperative anaesthetic management. As intraoperative haemodynamic stability is an important factor for surgeons to achieve better outcomes due to its effect on the quality of laparoscopic intervention, the investigator will observe its impact on this matter. Ninety patients scheduled for elective surgery will be randomly assigned by a closed-envelope method into three groups (n = 30) receiving either a subcostal plan block, an external oblique plane block, or a control block preoperatively. Each group receive standardised general anaesthesia and perioperative pain management protocol. The data to be recorded include a numeric rating scale, intraoperative and postoperative analgesic use, intraoperative haemodynamic parameters, and VAS score. Moreover, block performance time, motor block and side effects or complications will be noted.

Conditions

Peripheral Nerve Block; Cholecystectomy, Laparoscopic; Pain After Surgery

Keywords

Laparoscopic cholecystectomy; postoperative pain; subcostal plane block; external oblique intercostal plane block

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Numeric rating scale (NRS) worst pain imaginable as 10 points to zero for no pain.

  postoperative day 1

Secondary Outcomes (1)

• The total amount of analgesic drugs used

  postoperative day 1

Study Arms (3)

Control

NO INTERVENTION

No peripheral nerve block

External Oblique Plane Block

EXPERIMENTAL

Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, an external oblique plane block will be performed by the same anaesthesiologist under ultrasound guidance, using an external oblique muscle approach, in addition to standard analgesia applied in the control group.

Procedure: External Oblique Intercostal Plane Block

Subcostal Plane Block

ACTIVE COMPARATOR

Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, a subcostal block will be performed by the same anaesthesiologist under ultrasound guidance with subcostal approach, in addition to standard analgesia applied in the control group.

Procedure: Subcostal TAP block and spinal anesthesia group (STAP)

Interventions

External Oblique Intercostal Plane Block PROCEDURE

Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, an external oblique plane block will be performed by the same anesthesiologist under ultrasound guidance, using an external oblique muscle approach. A 22-gauge, 50-mm insulated stimulating needle will be used to administer 20 mL of anaesthetic solution (0.25% bupivacaine, 20 mL). Finally, 20 mL of local anaesthetic solution (0.25% bupivacaine anaesthetic solution) will be administered to disperse within the external oblique space.

External Oblique Plane Block

Subcostal TAP block and spinal anesthesia group (STAP) PROCEDURE

Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, a subcostal block will be performed by the same anaesthesiologist under ultrasound guidance with a subcostal approach. A 22-gauge, 50-mm insulated stimulating needle will be used to administer 20 mL of anaesthetic solution (0.25% bupivacaine, 20 mL). Finally, 20 mL of local anaesthetic solution (0.25% bupivacaine anaesthetic solution) will be administered to disperse within the subcostal space.

Subcostal Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists (ASA) Physical Status classification I to III
• Patients who will give informed consent to peripheral nerve blocks

You may not qualify if:

• Refusal to participate in the study
• History of neurologic deficits or neuropathy
• Infection at the site of the block application
• Coagulopathy
• bleeding disorders
• Allergy to local anaesthetics
• Uncooperative patients who cannot reliably respond to verbal pain evaluation
• Kidney Failure
• Liver Failure

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Kar S, Agrawal H, Yelamanchi R, Jain A, Kumar A, Agarwal N, Gupta N. Laparoscopy-guided transverse abdominis plane block versus port site infiltration for post-operative pain relief after laparoscopic cholecystectomy. J Minim Access Surg. 2025 Apr 1;21(2):126-132. doi: 10.4103/jmas.jmas_242_23. Epub 2024 Jul 30.

  PMID: 39095984 BACKGROUND

• Qi-Hong S, Xu-Yan Z, Xu S, Yan-Jun C, Ke L, Rong W. Comparison of Ultrasound-Guided Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block for Postoperative Analgesia in Elderly Patients After Laparoscopic Colorectal Surgery: A Prospective Randomized Study. Pain Ther. 2021 Dec;10(2):1709-1718. doi: 10.1007/s40122-021-00329-x. Epub 2021 Oct 15.

  PMID: 34652717 BACKGROUND

• Gangadhar V, Gupta A, Saini S. Comparison of analgesic efficacy of combined external oblique intercostal and rectus sheath block with local infiltration analgesia at port site in patients undergoing laparoscopic cholecystectomy: a randomized controlled trial. Anesth Pain Med (Seoul). 2024 Jul;19(3):247-255. doi: 10.17085/apm.24002. Epub 2024 Jul 31.

  PMID: 39118335 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Berna Caliskan

  Haseki Training and Research Hospital: Istanbul Haseki Egitim Ve Arastirma Hastanesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: January 1, 2024
• Primary Completion: December 28, 2024
• Study Completion: March 13, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)