RecruitingACTRN12620000714987

To compare types of anaesthetics for patients having elective laparoscopic surgery

Comparison of recovery after surgery between opioid and opioid-free anaesthesia for elective laparoscopic abdominal surgery

Sponsor

Wide Bay Hospital and Health Service

Enrollment

80 participants

Start Date

Jul 27, 2020

Study Type

Interventional

Conditions

Elective laparoscopic abdominal surgery

Summary

Opioids are routinely used during surgery however opioids are associated with a range of side effects. As an alternative, opioid-free anaesthesia (OFA) is an emerging mode of anaesthesia intended to avoid these side effects. This study will utilise a randomised clinical trial to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy or tubal ligation. Patient outcomes to be measured include: • Quality of Recovery (QoR-15); • Oral Morphine Equivalent Daily Dose (OMEDD) at 24 hours post operatively; • Time to first opioid (TTFO) dose; • Post-operative nausea and vomiting (PONV); • Post Anaesthetic Care Unit (PACU) Length of stay (LOS); and • Hospital Length of stay (LOS).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Opioid pain medications (such as morphine and fentanyl) are routinely used during surgery to manage pain, but they come with side effects including nausea, vomiting, constipation, drowsiness, and the potential for dependence. An emerging alternative approach called opioid-free anaesthesia (OFA) avoids opioids entirely by using other medications to manage pain during and after the operation. This trial is comparing OFA to standard opioid-containing anaesthesia in patients having elective laparoscopic (keyhole) surgery — either gallbladder removal or tubal ligation. Researchers are measuring recovery quality, post-operative pain, nausea and vomiting, how quickly patients first need pain relief, and length of hospital stay, to understand whether OFA offers a meaningful advantage. You may be eligible if you are between 18 and 65 years old, are in good general health (ASA classification I or II), and are booked for elective laparoscopic cholecystectomy (gallbladder removal) or tubal ligation. You must not have been using opioid medications regularly before surgery, must not have a BMI over 35, and must not be pregnant or allergic to any of the medications involved.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention (Arm B) will receive opioid-free anaesthesia during laparascopic surgery Opioid Free Anaesthesia induction Anxiolytic agent: 1-5 minutes prior to induction Midazolam 1 – 3mg intravenously Clonidine 1-3mcg/kg intravenously in 3 divided doses (at induction, mid surgery and end) Rapid stress block: Lidocaine as per local protocols. Induction hypnotic drug: Propofol 1 – 2.5mg/kg intravenously bolus or as per programmed Target Control Infusion Rapid preload reduction: Magnesium sulphate 40 mg / kg (according to patient ideal body weight ) Anti-inflammatory agents : Single dose perioperatively of Intravenous Dexamethasone 8 mg and Parecoxib 40mg intravenously. Neuromuscular blocker (if needed for anaesthesia or surgery): Choice of any neuromuscular blocker is at the anaesthetist’s discretion. Beta-blocker: Esmolol 10 – 50mg IV bolus 20 seconds prior to intubation On standby intravenous bolus medications as required for hypotension; Ephedrine 3 mg/mL Phenylephrine 100mcg/mL Metaraminol 0.5mg/mL All perioperative drugs administered will be audited at day 1 post surgery with the patient total oral morphine equivalent daily dose (oMEDD) calculated.

Locations(4)

Bundaberg Hospital - Bundaberg

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Mater Hospital Brisbane - South Brisbane

QLD, Australia

Surgical Treatment and Rehabilitation Service (STARS) - Herston

QLD, Australia

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ACTRN12620000714987