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

NCT07666646 | Not Yet Recruiting

• 1 other identifier: MTAPA-ESP-LC-SFT-2026-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Function; Post Operative Pain Control

Outcome Measures

Primary Outcomes (4)

• Forced Expiratory Volume in 1 Second (FEV1)

  Forced expiratory volume in one second (FEV1, liters) will be measured to assess postoperative pulmonary function.

  Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

• Forced Vital Capacity (FVC)

  Forced vital capacity (FVC, liters) will be measured to assess postoperative pulmonary function.

  Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

• FEV1/FVC Ratio

  The FEV1/FVC ratio (percentage, %) will be measured to assess postoperative pulmonary function.

  Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

• Peak Expiratory Flow (PEF)

  Peak expiratory flow (PEF, liters/minute) will be measured to assess postoperative pulmonary function.

  Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

Secondary Outcomes (3)

• Total Opioid Consumption

  First 24 postoperative hours

• Postoperative Pain Scores (NRS)

  Postoperative 1st, 6th, 12th, 18th, and 24th hours

• Quality of Recovery-15 (QoR-15)

  24 hours postoperatively

Study Arms (2)

M-TAPA Block

EXPERIMENTAL

An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

Procedure: Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA)

Erector spinae plane block (ESPB)

EXPERIMENTAL

An ultrasound-guided erector spinae plane block (ESPB) performed with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

Procedure: Erector spinae plane block (ESPB)

Interventions

Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) PROCEDURE

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.

M-TAPA Block

Erector spinae plane block (ESPB) PROCEDURE

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.

Erector spinae plane block (ESPB)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

Central Study Contacts

Muhammed N Tekcan, Anesthesiology and Reanimation

CONTACT

+905387931833; mntekcan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

TU (1)