← Back to all trials
Not Yet Recruiting
NCT07666646
Comparison of M-TAPA and ESPB for Postoperative Pulmonary Function After Laparoscopic Cholecystectomy
Conditions: Pulmonary Function, Post Operative Pain Control
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Kayseri City Hospital
Location: Kayseri City Hospital Kayseri Kocasinan
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 Criteria
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
Source: ClinicalTrials.gov (NCT07666646). StuddyBuddy aggregates publicly available trial information.