External Oblique Plane Block and Subcostal Tap Block for Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-13

Brief Summary

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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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Detailed Description

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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

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Peripheral Nerve Block Cholecystectomy, Laparoscopic Pain After Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

No peripheral nerve block

Group Type NO_INTERVENTION

No interventions assigned to this group

External Oblique 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 anaesthesiologist under ultrasound guidance, using an external oblique muscle approach, in addition to standard analgesia applied in the control group.

Group Type EXPERIMENTAL

External Oblique Intercostal Plane Block

Intervention Type 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 Plane Block

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.

Group Type ACTIVE_COMPARATOR

Subcostal TAP block and spinal anesthesia group (STAP)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No