Comparison of M-TAPA and ESPB for Postoperative Pulmonary Function After Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKayseri City Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
Infection at the planned block site
Known allergy to local anesthetic agents
Conversion to open surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA)
Procedure/SurgeryAn 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)
Procedure/SurgeryAn 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: M-TAPA BlockExperimental treatment 1 intervention
Group B: Erector spinae plane block (ESPB)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in one second (FEV1, liters) will be measured to assess postoperative pulmonary function.
Time frame
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.2
Forced Vital Capacity (FVC)
Forced vital capacity (FVC, liters) will be measured to assess postoperative pulmonary function.
Time frame
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.3
FEV1/FVC Ratio
The FEV1/FVC ratio (percentage, %) will be measured to assess postoperative pulmonary function.
Time frame
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.4
Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF, liters/minute) will be measured to assess postoperative pulmonary function.
Time frame
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.Secondary outcomes
1
Total Opioid Consumption
Total opioid consumption will be calculated as cumulative morphine dose delivered via patient-controlled analgesia (PCA) and rescue analgesic requirements during the first 24 postoperative hours.
Time frame
First 24 postoperative hours2
Postoperative Pain Scores (NRS)
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) at rest (static) and during movement (dynamic). (Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain)
Time frame
Postoperative 1st, 6th, 12th, 18th, and 24th hours3
Quality of Recovery-15 (QoR-15)
Postoperative recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. (Scores range from 0 to 150, where 0 indicates the worst possible recovery and 150 indicates the excellent/best possible recovery)
Time frame
24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov