CompletedPhase 1

Regional Scalp Block Versus IV Parecoxib for Post-operative Cranioplasty Surgery Pain: A Comparison of Pain Score.

Malaysia58 participantsStarted 2021-03-09

Plain-language summary

To compare the post cranioplasty pain score using scalp block versus conventional analgesia using IV Parecoxib and requirement of morphine between two groups as rescue analgesia

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

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

Fifty-eight patients with written informed consent and American Society of Anaesthesiologist (ASA) physical status I and II, aged 18 to 60 years old, pre-operative GCS of 15 and underwent elective cranioplasty surgery under general anaesthesia (GA) between September 2019 until March 2022 were selected for the study and randomized by computer generated randomization into two groups; Regional Scalp Block (n = 29) and IV Parecoxib (n = 29). The patients were excluded from this study if they were a known allergy to local anesthesia or NSAIDS, had risk for bleeding tendency or coagulopathy, low preoperative platelets count (\< 100 x103/mL) or with underlying bronchial asthma. The patient withdrawn from the study if he or she was not able to score post pain using Visual analog Scale (VAS) or had redo surgery for postoperative bleeding.

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

pain score

Timeframe: 12 hours

Trial details

NCT IDNCT05442411

SponsorUniversiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-08

View on ClinicalTrials.gov More Postoperative Pain trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

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