NCT07061262

External Oblique Plane Block and Subcostal Tap Block for Laparoscopic Cholecystectomy

The Comparison of Postoperative Analgesic Efficacy Between External Oblique Plane Block and Subcostal Tap Block in Patients Undergoing Laparoscopic Cholecystectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Haseki Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients will receive standard general anaesthesia under standard monitorization; induction with 0,1-0,4 mg/kg midazolam, 2-2,5 mg/kg propofol, 1-2 mcq/kg fentanyl, 0,6-1,0 mg /kg rocuronium followed by 2% MAC sevoflurane in an air-oxygen mixture for maintenance of anaesthesia. Randomization is designed with concealed opaque envelope in a 1:1 ratio into two block groups (n= 30): subcostal plane block (Group A) and external oblique plane block (Group B) and control group ( Group C ). All blocks will be performed before surgical incision by a single experienced regional anaesthesiologist (A.A.) under ultrasound guidance with same local anaesthetic doses: 0.25% bupivacaine anaesthetic solution of 20 ml. The anaesthesia technician will record the duration of the block procedure. Then the investigator will apply dexamethasone 8 mg (IV), NSAIDs and after the patient will be ready for surgical incision. Intraoperative haemodynamic values (heart rate, systolic and mean arterial pressure) will be recorded by the same technician. The same analgesia protocol will be applied, consisting of an infusion of remifentanil (0.01 to 0.1 μg · kg-1 · min-1) if only needed to maintain heart rate and mean blood pressure within 20% of pre-induction values, and 1 g of paracetamol. Pain will be evaluated using both a numeric rating scale (0-10) and a verbal rating scale, starting at the post-anaesthesia care unit (PACU) and at time intervals of 2, 6, 12, and 24 hours postoperatively. Patients with persistent pain scores of higher than 4 out of 10 will receive rescue analgesia with 1mg/kg (maximum daily dose, 4x1) tramadol and 1 g (maximum daily dose, 4x1) paracetamol.

Conditions

• Peripheral Nerve Block
• Cholecystectomy, Laparoscopic
• Pain After Surgery

Interventions

Type	Name	Description
PROCEDURE	External Oblique Intercostal Plane Block	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.
PROCEDURE	Subcostal TAP block and spinal anesthesia group (STAP)	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-28
• Completion: 2025-03-13
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: Turkey (Türkiye)