Postoperative pain after laparoscopic cholecystectomy can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects. The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB) are two ultrasound-guided regional anesthesia techniques that have been shown to provide effective postoperative analgesia in abdominal surgery. However, comparative clinical data between these two techniques in laparoscopic cholecystectomy are limited. This randomized, single-blind clinical trial aims to compare the postoperative analgesic effectiveness of M-TAPA and ESPB in adult patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, time to first analgesic requirement, and patient satisfaction will be evaluated.
This study is designed as a prospective, randomized, single-blind controlled clinical trial conducted in adult patients scheduled for elective laparoscopic cholecystectomy. The primary objective of the study is to compare the postoperative analgesic effectiveness of the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB). Eligible patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly assigned in a 1:1 ratio to receive either M-TAPA or ESPB. Randomization will be performed using a computer-generated random number sequence, and allocation will be concealed in sealed, opaque envelopes to prevent selection bias. All blocks will be performed under ultrasound guidance by experienced anesthesiologists using standard local anesthetic agents routinely applied in clinical practice. The study is designed as single-blind, with patients blinded to group allocation. Postoperative pain intensity will be assessed using the numerical rating scale (NRS) at 0, 1, 6, 12, and 24 hours after surgery. Additional outcome measures include total opioid consumption within the first 24 postoperative hours, time to first analgesic requirement, need for rescue analgesia, and patient satisfaction. Adverse events related to regional anesthesia techniques will be recorded. The study follows the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the relevant Clinical Research Ethics Committee prior to study initiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
Başakşehir Çam and Sakura City Hospital
Istanbul, Turkey (Türkiye)
Total Opioid Consumption in the First 24 Hours
Total cumulative opioid consumption within the first 24 hours after surgery, recorded as intravenous tramadol equivalent dose.
Time frame: within the first 24 hours postoperatively
Pain intensity at rest (NRS)
Postoperative pain intensity at rest assessed using the Numerical Rating Scale (NRS).
Time frame: PACU, 3, 6, 12, 18, and 24 hours postoperatively
Pain intensity during movement (NRS)
Postoperative pain intensity during movement assessed using the Numerical Rating Scale (NRS).
Time frame: PACU, 3, 6, 12, 18, and 24 hours postoperatively
Rescue analgesic requirement
Number of patients requiring rescue analgesic medication.
Time frame: Within the first 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Incidence of postoperative nausea and vomiting assessed by a blinded observer using a five-point verbal descriptive scale
Time frame: At postoperative hours 0, 6, 12, and 24
Time to first rescue analgesia
Time from the end of surgery to the first administration of rescue analgesic medication.
Time frame: Within the first 24 hours postoperatively
Quality of recovery (QoR-15)
Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
Time frame: Postoperative 24 hours
Patient satisfaction
Patient satisfaction with postoperative analgesia assessed using a 10-point numerical rating scale.
Time frame: Postoperative 24 hours
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