Active — Not RecruitingNot Applicable

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

Romania82 participantsStarted 2024-01-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Elective surgery * Subumbilical incision (median, Phannenstil) * Total or subtotal hysterectomy * Age over 18 years Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative Opioid Consumption (Tramadol)

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

Postoperative Pain Intensity

Timeframe: From end of surgery to 24 hours postoperatively

Trial details

NCT IDNCT07139691

SponsorMatild Keresztes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

View on ClinicalTrials.gov More Postoperative Pain Following Hysterectomy trials