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Clinical Trials in Turkey / NCT07666646
Recruiting Not applicable

Comparison of M-TAPA and ESPB for Postoperative Pulmonary Function After Laparoscopic Cholecystectomy

NCT07666646 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-08-11
Last updated
2026-08-13

Condition(s) studied

Pulmonary FunctionPost Operative Pain Control

Investigational drug(s) / intervention(s)

Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA)Erector spinae plane block (ESPB)

Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA): An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) was performed bilaterally under sterile conditions. The ultrasound transducer was placed in the sagittal plane at the 9th-10th rib level. The probe was angled to visualize the underside of the costal margin. After identification of the target fascial plane, an echogenic needle was advanced in-plane until the tip was positioned beneath the costal cartilage. Hydrodissection with 5 mL of saline was used to confirm correct needle placement. Following confirmation, 20 mL of 0.25% bupivacaine was administered on each side, for a total volume of 40 mL. Blocks were performed under ultrasound guidance using an 80 mm echogenic needle and a 6-10 MHz linear transducer.

Erector spinae plane block (ESPB): An ultrasound-guided erector spinae plane block (ESPB) was performed bilaterally at the T9 vertebral level under sterile conditions. A high-frequency linear ultrasound probe (6-10 MHz) was used to identify the erector spinae muscle and transverse process. An 80 mm echogenic needle was advanced in-plane in a cranio-caudal direction until the tip was positioned in the fascial plane deep to the erector spinae muscle. Hydrodissection with saline was used to confirm correct needle placement, followed by administration of 20 mL of 0.25% bupivacaine on each side, for a total volume of 40 mL.

Study summary

This prospective, randomized, controlled clinical trial aims to compare the effects of two ultrasound-guided fascial plane blocks, the Erector Spinae Plane Block (ESPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), on postoperative pulmonary function and analgesic consumption in patients undergoing laparoscopic cholecystectomy. Laparoscopic cholecystectomy is one of the most frequently performed abdominal surgical procedures worldwide. Despite minimally invasive techniques, postoperative pain remains a significant clinical problem due to port-site trauma, pneumoperitoneum, diaphragmatic irritation, and visceral manipulation.

Inadequate pain control may lead to impaired respiratory mechanics, reduced mobilization, delayed recovery, and an increased risk of postoperative pulmonary complications. Postoperative pulmonary dysfunction is a common consequence of upper abdominal surgery and may persist for several days, contributing to reductions in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), which are associated with increased postoperative morbidity.

Although opioid-based analgesia is widely used, it is associated with adverse effects such as respiratory depression, nausea, vomiting, ileus, and delayed recovery. Therefore, regional anesthesia techniques and multimodal analgesia strategies are increasingly recommended to reduce opioid consumption while improving pain control.

ESPB and M-TAPA are ultrasound-guided fascial plane blocks used for postoperative analgesia in abdominal surgery. ESPB provides somatic and visceral analgesia through the spread of local anesthetic affecting the spinal nerve rami, while M-TAPA targets the anterior branches of the thoracoabdominal nerves to provide extensive anterior and lateral abdominal wall analgesia.

Despite their increasing use, there is limited high-quality comparative evidence evaluating the effects of ESPB and M-TAPA on postoperative pulmonary function and opioid consumption in laparoscopic cholecystectomy. This study compares these two regional anesthesia techniques in a randomized controlled design to evaluate their impact on postoperative respiratory function and analgesic requirements.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18-70 years * American Society of Anesthesiologists (ASA) physical status I-III * Patients scheduled for elective laparoscopic cholecystectomy * Patients who provide written informed consent * Patients who are able to cooperate and perform pulmonary function tests (PFTs) Exclusion Criteria: * Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia * Infection at the planned block site * Known allergy to local anesthetic agents * Conversion to open surgery * Hemodynamic instability * Inability to cooperate with pulmonary function tests (PFTs) * Pre-existing severe pulmonary disease (e.g., severe chronic obstructive pulmonary disease or restrictive lung disease) * Chronic opioid use or opioid dependence * Pregnancy or breastfeeding * Active smokers * Body mass index (BMI) \> 35 kg/m²

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kayseri City Hospital Kayseri Kocasinan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07666646 on ClinicalTrials.gov ↗ ← All trials in Turkey