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

NCT07139691 | Active Not Recruiting

• 1 other identifier: 651/12.01.2024
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain Following Hysterectomy

Keywords

Transversus Abdominis Plane Block; Postoperative Pain Management; Hysterectomy

Outcome Measures

Primary Outcomes (2)

• Cumulative Opioid Consumption (Tramadol)

  Total intravenous Tramadol administered for postoperative pain management will be recorded during the first 24 hours following elective hysterectomy. Unit of Measure: Milligrams (mg) of IV Tramadol

  From end of surgery (arrival in recovery room) to 24 hours postoperatively

• Postoperative Pain Intensity

  Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be recorded at 0, 1, 4, 6, and 24 hours postoperatively, both at rest and during movement.

  From end of surgery to 24 hours postoperatively

Secondary Outcomes (4)

• Intraoperative Opioid Consumption During Hysterectomy

  From induction of anesthesia until completion of surgery

• Postoperative Quality of Recovery Assessed by QoR-15

  At 48 hours after completion of surgery

• Length of Hospital Stay

  Up to 2 weeks

• Patient Satisfaction with Postoperative Pain Management

  At 24 hours after completion of surgery

Study Arms (2)

Arm 1: TAP Block with Lidocaine and Ropivacaine

EXPERIMENTAL

Participants in this arm will receive a 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% with a calculated dose of 0.4 ml/kg per side, in addition to standard analgesia.

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%

Arm 2: Standard Analgesia (Control)

ACTIVE COMPARATOR

Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy. This regimen typically includes systemic analgesics (e.g., intravenous or oral non-opioid analgesics and opioids as needed) but does not include a Transversus Abdominis Plane (TAP) block.

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

Interventions

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% PROCEDURE

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.

Arm 1: TAP Block with Lidocaine and Ropivacaine

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

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.

Arm 2: Standard Analgesia (Control)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biologically female patients are eligible to participate, as hysterectomy is a surgical procedure performed exclusively on individuals with a uterus.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery
• Subumbilical incision (median, Phannenstil)
• Total or subtotal hysterectomy
• Age over 18 years

You may not qualify if:

• Patient refusal
• Infection at the puncture site
• Chronic pain
• Chronic use of analgesics
• Contraindications to NSAIDs, local anesthetics, or opioids (e.g., tramadol: antidepressants, epileptic disorders)
• Severe hepatic disease
• Renal insufficiency (Creatinine Clearance ≤ 30 ml/min)
• Coagulopathy (Platelet count ≤ 75,000, INR ≥ 1.4)

Sponsors & Collaborators

• Matild Keresztes: lead

Study Sites (1)

County Emergency Clinical Hospital of Targu Mureș

Târgu Mureş, Mureș County, 540136, Romania

Location

Study Officials

• Janos Szederjesi, MD, PhD

  Dept. of Anesthesiology & Intensive Care, George Emil Palade Univ. of Medicine & Pharmacy, Târgu Mureș

  STUDY CHAIR

• Matild Keresztes, MD

  Dept. of Anesthesiology & Intensive Care, George Emil Palade Univ. of Medicine & Pharmacy, Târgu Mureș

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 24, 2025
• Study Start: January 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after primary publication and available for 2 years
• Access Criteria: Researchers must submit a methodologically sound proposal that is approved by the study's steering committee. Data will be shared via a secure data repository.

Locations

RO (1)