Clinical trial NCT06810206: A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC)
Official title: A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC): A Double-Blinded Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Keywords: postoperative pain
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blinded, randomized comparative study with two parallel groups. Participants will be randomly assigned to receive either the MTAPA or the EOIPB.
Primary purpose: PREVENTION

Brief summary: Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus it's an economical operation. Nevertheless, it results in moderate to severe pain.(2).By using regional anesthesia techniques to effectively control pain and lessen the requirement for opioid analgesics, ERAS implementation has demonstrated significant decreases in opioid usage and improved overall patient outcomes (3). (4) To minimize the need for opioids, opioid sparing anesthesia employs a multimodal strategy that includes nonsteroidal anti-inflammatory medications, paracetamol, local anesthetics (LA), and, if feasible, regional anesthetic techniques and regional analgesia. (5) With fewer systemic side effects, regional anesthetic techniques-like nerve blocks-offer tailored pain treatment. The best regional pain management strategy for LC surgery is still unknown, though.(4) Modified Thoracoabdominal Nerves Block Through Perichondral Approach (M-TAPA) Block is a new technique defined as a modification of TAPA Block in which local anaesthetics are administered only to the underside of the perichondral surface, creating a sensory block between T5-T12 dermatomes. While the external oblique intercostal plane (EOIPB) block provides blockade of the lateral and anterior cutaneous branches of the intercostal nerves from T6/7 to T10/11.This study aims to compare the efficacy of both MTAPA and EOIPB in patients undergoing LC surgery .


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-65 years
* Scheduled for Laparoscopic cholecystectomy surgery
* ASA (American Society of Anaesthesiologists) physical status I-II

Exclusion Criteria:

* Known allergy to local anaesthetics
* Coagulopathy or anticoagulant use
* Infection at the site of block
* Chronic pain conditions
* Advanced liver or kidney failure
* History of abdominal surgery or trauma
* Alcohol or drug use
* Refusal to participate
* Chronic opioid consumption
* Use of painkillers in the preoperative 24hours
* Conversion to open surgery
* Body mass index ( BMI ) \> 35

Primary outcomes:
measure: comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS
timeFrame: . NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period.
Secondary outcomes:
measure: evaluating the quality of recovery via the QOR-40 questionnaire.
timeFrame: the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU .
measure: identifying dermatomal coverage of each block via pinprick test.
timeFrame: Dermatomal coverage will be tested using pinprick test in PACU after evaluating the QoR-40 within the first hour postoperatively
measure: evaluating the efficacy of each block in providing analgesia intraoperatively by measuring amount of fentanyl consumed in micrograms
timeFrame: intraoperatively
measure: Total opioid consumption in the first 24 hours postoperatively in mgs
timeFrame: postoperatively with a total of 24 hour
measure: Time to first mobilization in hours
timeFrame: postoperatively up to 24 hour
measure: Incidence of block-related complications
timeFrame: postoperatively with a total of 24 hour
measure: Incidence of PONV.
timeFrame: every six hours for a total of 24 hour postoperatively
measure: the Time to first rescue opioid
timeFrame: it will be measured postoperatively for a total period of 24 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculity of medicine , Kasr Al Aini Hospitals , Cairo University
Study officials:
References:
citation: Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.