Analgesic Effect of M-TAPA and TAPB on Laparoscopic Cholesistectomy

NCT ID: NCT06662617

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-01-01

Brief Summary

Cholecystectomy is the most frequently performed abdominal surgery in developed nations, with laparoscopic cholecystectomy being recognized as the gold standard technique for treating gallstones.

The efficacy of TAP block for pain relief has been well-documented following laparoscopic cholecystectomy procedures. Recently, m-TAPA block has emerged as an alternative analgesic technique for abdominal surgeries.

This study aims to evaluate and compare the effectiveness of these two analgesic methods in managing postoperative pain after laparoscopic cholecystectomy.

Detailed Description

Cholecystectomy is the most commonly performed abdominal surgery in developed countries, with laparoscopic cholecystectomy regarded as the gold standard technique for gallstone treatment.

Postoperative pain following laparoscopic cholecystectomy is influenced by several factors, making it a complex and predominantly visceral pain. These factors include phrenic nerve irritation due to CO2 insufflation, abdominal distension, port site incisions, the effects of gallbladder removal, and individual patient characteristics.

Regional analgesia has gained widespread acceptance from both patients and physicians, becoming a key component of multimodal analgesia techniques. The transversus abdominis plane (TAP) block has proven effective in reducing postoperative pain in surgeries such as hysterectomy, cholecystectomy, cesarean section, and colorectal procedures.

The Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) involves administering a local anesthetic to the underside of the perichondral surface. This technique provides effective analgesia for the anterior and lateral thoracoabdominal regions.

The purpose of this study is to compare the efficacy of US-guided M-TAPA block with TAP block for postoperative analgesia following cholecystectomy.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group M-TAPA

Patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Group Type: ACTIVE_COMPARATOR

modified thoracoabdominal nerve block through perichondrial approach

Intervention Type: OTHER

After the patient fell asleep, surgery was not yet started. Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.

Group TAP

Patients had bilateral TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Group Type: ACTIVE_COMPARATOR

Transversus Abdominal Plane block

Intervention Type: OTHER

After the patient fell asleep, surgery was not yet started. Following sterile conditions for bilateral TAP block application, USG will be placed transversely on the mid-axillary line between the iliac crest and subcostal planes. Using the In Plane technique, the block needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles and the location will be confirmed by administering 5 ml of saline . After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.

Interventions

modified thoracoabdominal nerve block through perichondrial approach

After the patient fell asleep, surgery was not yet started. Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.

Intervention Type: OTHER

Transversus Abdominal Plane block

After the patient fell asleep, surgery was not yet started. Following sterile conditions for bilateral TAP block application, USG will be placed transversely on the mid-axillary line between the iliac crest and subcostal planes. Using the In Plane technique, the block needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles and the location will be confirmed by administering 5 ml of saline . After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of
• Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria

• Patients who did not give consent,
• patients with coagulopathy,
• patients with signs of infection at the block application site,
• patients using anticoagulants,
• patients with local anesthetic drug allergies,
• patients undergoing open surgery,
• patients with unstable hemodynamics,
• patients who could not cooperate during postoperative pain assessment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Hüseyin Özden

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medicana Sivas Hospital

Sivas, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Hüseyin Özden, associate professor

Role: primary

md.huseyinozden@gmail.com

+905070117130

Other Identifiers

2024-03/03

Identifier Type: -

Identifier Source: org_study_id