RecruitingPhase 4ACTRN12612000104853

Total and free serum Ropivacaine Concentrations for patients receiving Continuous Transversus Abdominis plane block for Postoperative analgesia after abdominal surgery: Pilot Study


Sponsor

Dr Sarika Kumar

Enrollment

15 participants

Start Date

Oct 5, 2011

Study Type

Interventional

Conditions

Summary

This is a pilot study looking into safety of giving bolus of ropivacaine followed by continous infusion for 48 hrs in Transversus Abdominis Plane Block. Safety of this regime will be established by serial blood samples to analyse toal & free ropivacaine concentration , Serail ECG 's looking into QTc interval & patient will be observed for sign & symptoms of Local anaesthetic toxicity


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study is checking how safe it is to use a continuous nerve-blocking technique called a transversus abdominis plane (TAP) block to control pain after abdominal surgery. The technique involves injecting a local anaesthetic called ropivacaine into the space between the abdominal muscles to numb the area. The study measures how much of the drug enters the bloodstream over 48 hours and watches for any signs of toxicity (such as heart rhythm changes). You may be eligible if: - You are 18 to 80 years old - You are having elective or emergency abdominal surgery - Your overall health status is reasonably good (ASA score less than 4) - You can speak and understand English adequately You may NOT be eligible if: - You have an allergy to local anaesthetic - You are pregnant - You are taking regular opioid (strong painkiller) or chronic pain medications - You have an abnormal heart tracing (QTc interval above 0.45 seconds for men, 0.47 for women) - You take certain medications affecting drug metabolism (ciprofloxacin or fluvoxamine) - You take medications that affect heart rhythm (such as haloperidol, amiodarone, or sotalol) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients having mid line incision will have TAP block catheter towards the end of surgery. They will recieve 20 mls of 0.5% ropivacaine Bilateral (both sides) followed by continous infusion of 10mls

Patients having mid line incision will have TAP block catheter towards the end of surgery. They will recieve 20 mls of 0.5% ropivacaine Bilateral (both sides) followed by continous infusion of 10mls/hr of 0.2% ropivacaine for 48hrs which will be started 30mins post 2nd bolus.


Locations(1)

Australia

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ACTRN12612000104853