Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06662617

Comparison of the Effects of M-TAPA and TAP Nerve Block Applications on Postoperative Pain Scores and Analgesia Requirements in Laparoscopic Cholecystectomy

Led by Cumhuriyet University · Updated on 2024-11-06

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Laparoscopic cholecystectomy is the most common abdominal surgery for treating gallstones, and managing postoperative pain after this procedure is important. This research compares two nerve block techniques, the established transversus abdominis plane (TAP) block and the newer modified thoracoabdominal nerve block through perichondrial approach (M-TAPA), to see which is more effective for pain relief after surgery. Participants receive either a bilateral M-TAPA block or a bilateral TAP block using 0.25% bupivacaine (40 ml total) at the end of their laparoscopic cholecystectomy. Both blocks are guided by ultrasound and performed before surgery starts, with the same procedure applied to both sides of the body. The study randomly assigns patients to one of these two nerve block groups. During the study, patients' pain levels will be measured using a numerical rating scale over the first 24 hours after surgery. Researchers will also track the amount of tramadol pain medication used in that period. Participants will be monitored closely to assess pain control and any side effects. The study runs until early 2025, aiming to improve pain management after gallbladder surgery.

CONDITIONS

Brief Title

Analgesic Effect of M-TAPA and TAPB on Laparoscopic Cholesistectomy

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients older than 18 years of age
  • Undergoing elective laparoscopic cholecystectomy under general anesthesia
  • Classified as American Society of Anesthesiologists (ASA) I, II, or III
  • Able to cooperate during postoperative pain assessment
Not Eligible

You will not qualify if you...

  • Patients who did not give consent
  • Patients with coagulopathy (blood clotting disorders)
  • Patients with infection signs at the block application site
  • Patients using anticoagulant medications
  • Patients allergic to local anesthetic drugs
  • Patients undergoing open surgery instead of laparoscopic
  • Patients with unstable hemodynamics
  • Patients unable to cooperate during postoperative pain assessment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day (day of surgery)

Participants undergo laparoscopic cholecystectomy and receive either the M-TAPA block or the TAP block for postoperative pain control after surgery.

1 visit (in-person, surgery day)

Post-operative Follow-up

Duration - 24 hours post-surgery

Participants are monitored for pain scores and analgesia requirements during the first 24 hours after surgery.

1 follow-up visit within 24 hours after surgery

Trial Site Locations

Total: 1 location

1

Medicana Sivas Hospital

Sivas, Turkey (Türkiye)

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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