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ACTIVE NOT RECRUITING
NCT07139691
NA

TAP Block With Lidocaine and Ropivacaine 0.2% (0.4 ml/kg/Side) for Pain and Opioid Reduction After Hysterectomy

Sponsor: Matild Keresztes

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate whether the Transversus Abdominis Plane (TAP) block can effectively reduce postoperative pain and opioid consumption in patients undergoing elective hysterectomy. The main questions it aims to answer are: Primary outcome: Does performing a pre-incisional TAP block reduce postoperative pain scores and opioid consumption compared to standard analgesic management? Secondary outcomes: Does TAP block reduce intraoperative opioid requirements during hysterectomy? Does TAP block enhance postoperative recovery and facilitate early mobilization? Does TAP block reduce the length of hospital stay? Does TAP block improve overall patient satisfaction following hysterectomy? If there is a comparison group: Researchers will compare patients receiving TAP block with lidocaine and ropivacaine (0.2%, 0.4 ml/kg per side) to patients receiving standard analgesia without TAP block to see if the TAP block provides superior pain relief, lowers opioid needs, and improves recovery outcomes. Participants will: Undergo elective total or subtotal hysterectomy. Receive either a TAP block (intervention group) or standard analgesic management (control group). Have their intraoperative and postoperative opioid consumption, pain scores, recovery parameters, and satisfaction assessed.

Official title: Efficacy of TAP Block in Postoperative Pain Management for Elective Hysterectomy: a Randomized Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2024-01-12

Completion Date

2026-12-31

Last Updated

2025-08-24

Healthy Volunteers

No

Interventions

PROCEDURE

Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2%

After the induction of general anesthesia, bilateral TAP block will be performed in patients from Group 1. The administered dose will include 0.2% lidocaine combined with 0.2% ropivacaine, at a dose of 0.4 ml/kg per side, without exceeding toxic dose limits per kg.

DRUG

Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy

Participants in this arm will receive standard multimodal systemic analgesia for postoperative pain management following elective hysterectomy. The regimen includes Paracetamol (oral or intravenous) 1g/24 hour, Ibuprofen IV 1200 mg/24 hour, or Parecoxib 80 mg/24 hour IV, and Tramadol 100 mg IV. Additional rescue doses of Tramadol (50-100 mg IV every 4-6 hours) may be administered based on pain intensity, with a maximum of 400 mg/24 hours (or 300 mg/24 hours for patients aged ≥75 years). No Transversus Abdominis Plane (TAP) block will be performed in this group. Pain intensity, opioid use, and postoperative recovery scores will be evaluated and compared with the TAP block intervention group.

Locations (1)

County Emergency Clinical Hospital of Targu Mureș

Târgu Mureş, Mureș County, Romania