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NCT Number: NCT07061262

External Oblique Plane Block and Subcostal Tap Block for Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Peripheral Nerve Block Cholecystectomy, Laparoscopic Neurologic Manifestations Pain Pain After Surgery Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Score

    Time frame: postoperative day 1

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

Secondary outcomes

  1. The total amount of analgesic drugs used

    Time frame: postoperative day 1

    The total amount of analgesic drugs used during the postoperative follow-up

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

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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