RecruitingPhase 2ACTRN12621000589886

The effect of lignocaine on pain outcomes for women undergoing gynaecological surgery for chronic pelvic pain

The effect of perioperative intravenous lignocaine on pain outcomes at operative gynaecological laparoscopy in women with chronic pelvic pain, a randomised controlled trial.


Sponsor

Monash health

Enrollment

70 participants

Start Date

Jun 16, 2021

Study Type

Interventional

Conditions

Summary

We propose a double-blinded prospective randomised placebo-controlled clinical trial. We aim to investigate the effect of perioperative intravenous lignocaine in women with chronic pelvic pain (CPP) undergoing operative gynaecological laparoscopy at the Monash Endosurgery unit at Moorabbin Hospital in Melbourne Victoria. CPP is a common cause of physical, emotional and socio-economical dysfunction in women which is often complex and challenging to manage. Operative laparoscopy is frequently a component of multidisciplinary management, however the benefits of surgery are often reduced or counteracted by central sensitization pathognomonic to CPP. Pre-existing pain and inadequate pain management in the perioperative period are strong predictors of persisting pain and dissatisfaction with surgery postoperatively. Intravenous lignocaine (IVL) has anti-inflammatory, analgesic and anti-hyperalgesic properties impacting the peripheral and central nervous system. IVL infusions improve pain scores in patients with non-gynaecological chronic pain conditions. Perioperative IVL improves postoperative pain, analgesia requirements, nausea and vomiting and recovery of bowel function in a variety of surgical fields with minimal adverse effects and a good safety profile. Whilst previous studies of perioperative IVL have largely excluded patients with chronic pain, this patient group is likely to benefit most from the use of IVL in the perioperative period. We hypothesis that IVL compared to placebo will significantly improve visual analogue scale (VAS) pain scores in the perioperative period for women with CPP undergoing operative gynaecological laparoscopy.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic pelvic pain is a complex, often debilitating condition affecting many women, and it frequently has multiple contributing factors including endometriosis or central sensitisation — where the nervous system becomes amplified and over-sensitive to pain signals. Surgery (laparoscopy) is often part of treatment, but pain often persists or worsens because the sensitised nervous system remains unchanged. Intravenous lignocaine (a local anaesthetic given through a drip) has anti-inflammatory and pain-calming properties that may help break this cycle. You may be eligible if you are a pre-menopausal woman under 60, experiencing pelvic pain on most days for the past 6 months, and scheduled for gynaecological laparoscopy at Moorabbin Hospital (Monash Health) in Melbourne. Women with contraindications to lignocaine (including certain heart conditions or use of beta-blockers), known malignancy, or current methadone use are not eligible. This is a double-blind trial: participants receive either intravenous lignocaine or a saline placebo drip during and after surgery, without knowing which. Pain scores before and after surgery are the main outcome. The hypothesis is that women with chronic pelvic pain will benefit most from this approach, which is rarely studied in this group despite potentially being where it has the greatest impact.

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Interventions

Double blind randomised controlled trial of the use of peri-operative intravenous lignocaine compared to placebo matched control intravenous saline at the time of operative laparoscopy for chronic pel

Double blind randomised controlled trial of the use of peri-operative intravenous lignocaine compared to placebo matched control intravenous saline at the time of operative laparoscopy for chronic pelvic pain conditions. Description of drug intervention: Name - Lignocaine, or Lidocaine (International Non-proprietary Name) Dose, duration and mode of administration - 1.5mg/kg intravenous bolus with induction of anaesthesia (max 200mg), followed by 2mg/kg/hour intravenous infusion during anaesthesia. Cease infusion prior to emergence from anaesthesia.


Locations(3)

Monash Medical Centre - Moorabbin campus - East Bentleigh

VIC, Australia

Dandenong Hospital- Monash Health - Dandenong

VIC, Australia

Casey Hospital - Berwick

VIC, Australia

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ACTRN12621000589886


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