Efficacy of Modified Thoracoabdominal Nerves Block Through Perichondrial Approach in Total Laparoscopic Hysterectomies

NCT06116409 | Completed

• 1 other identifier: DrLutfiKirdarANESTHESİA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

TAPA is a new analgesic block technique that involves the injection of local anesthetics into the thoracoabdominal nerves using a perichondrial approach. Application to the undersurface of the rib cartilage is considered as Modified TAPA (M-TAPA). These techniques are commonly applied for postoperative analgesia in surgeries and are effective and safe when performed under ultrasound guidance.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Evaluate patients' postoperative pain

  The primary aim of this study is to evaluate and compare the postoperative analgesic effectiveness of modified thoracoabdominal nerve block (M-TAPA) in total laparoscopic hysterectomy. Numerical rating scale (NRS) will be used for postoperative analgesic effectiveness. NRS ranging from 0 (no pain) to 10 (worst imaginable pain) will be used for pain assessment.NRS assessed at 2, 6, 12, and 24 hours postoperatively.

  postoperative 24 hours

Secondary Outcomes (1)

• Number of Participants Requiring Rescue Tramadol Within 24 Hours Postoperatively

  Up to 24 hours postoperatively

Study Arms (2)

M-TAPA GROUP

EXPERIMENTAL

Group 1 patients will receive a modified thoracoabdominal nerve block (M-TAPA) with a perichondrial approach using 40 ml of 0.25% bupivacaine guided by ultrasound (US).

Drug: Bupivacain

CONTROL GROUP

NO INTERVENTION

Patients in Group 2 (the control group) will receive routine multimodal analgesia, which includes tramadol at a dose of 1 mg/kg and paracetamol at a dose of 15 mg/kg.

Interventions

Bupivacain DRUG

Bupivacaine was used for postoperative analgesia block.

M-TAPA GROUP

Eligibility Criteria

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

You may qualify if:

• electively total laparoscopic hysterectomy operations
• ASA II-III,
• between 18-65 years

You may not qualify if:

• ASA IV and above • over 65 - under 18 years of age allergy to local anesthetics

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• hülya yılmaz ak

  Kartal Dr Lutfi Kırdar City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist medical doktor

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 3, 2023
• Study Start: September 1, 2023
• Primary Completion: November 24, 2023
• Study Completion: November 30, 2023
• Last Updated: March 2, 2026

Record last verified: 2025-02

Locations

TU (1)