Analgesic Effect of M-TAPA and TAPB on Laparoscopic Cholesistectomy

NCT06662617 | Recruiting

• 1 other identifier: 2024-03/03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

laparoscopic cholecystectomy; m-tapa; tap

Outcome Measures

Primary Outcomes (1)

• numerical rating scale scores

  numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

  postoperative 24 hours

Secondary Outcomes (1)

• total tramadol consumption

  postoperative 24 hours

Study Arms (2)

Group M-TAPA

ACTIVE COMPARATOR

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.

Other: modified thoracoabdominal nerve block through perichondrial approach

Group TAP

ACTIVE COMPARATOR

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

Other: Transversus Abdominal Plane block

Interventions

modified thoracoabdominal nerve block through perichondrial approach 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 M-TAPA

Transversus Abdominal Plane block 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.

Group TAP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Medicana Sivas Hospital

Sivas, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: There are two models for this study. Modified Perichondral Approach Thoracoabdominal Nerve block (M-TAPA block) group, and Transversus Abdominal Plane Block (TAP block) group

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)