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M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin

Postoperative Analgesic Efficacy of Intraperitoneal Bupivacaine, Bupivacaine and Dexmedetomidine With Modified-Pericondrial Approach Thoracoabdominal Nerve Block (M-TAPA) in Laparoscopic Cholecystectomy Surgeries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06482229
Enrollment
51
Registered
2024-07-01
Start date
2024-07-01
Completion date
2024-09-01
Last updated
2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Anesthesia Morbidity

Brief summary

Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.

Interventions

PROCEDUREapplication for postoperative analgesia

three different methods will be applied to reduce patients' postoperative pain

Sponsors

Sivas State Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Laparoscopic cholecystectomy surgery planned * ASA #-II-III classification * Willingness to participate in the study

Exclusion criteria

* Bleeding disorders * Signs of infection at the block application site * Conversion to open surgery * Allergy to local anesthetics * Unstable hemodynamics * Inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
pain scoresTime Frame: 24 hours after the procedurezero meaning no pain and 10 meaning the worst pain imaginable

Secondary

MeasureTime frameDescription
total analgesic consumption24 hours after the proceduretotal rescue analgesic consumption of patients will be evaluated

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026