None listed
Conditions
Brief 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.
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 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 anaesthe
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.
Sponsors
Monash health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- Women requiring elective operative gynaecological laparoscopy for benign indication as determined and agreed by both the surgeon and the participant. - Experience of pelvic pain on most days in the preceding 6 months - Over 18years old and premenopausal at the time of the surgery. - Participants who understand the conditions of the study and are willing to participate for the duration of study including all follow-up. - Participants who are capable of, and have given, informed consent to their participation in the study. - English language or an available translator sufficient to complete the validated quality of life instruments. - Surgery at Moorabbin Hospital under specialised Endosurgery unit
Exclusion criteria
- Contraindications to lignocaine (Hypersensitivity; Myasthenia gravis; Severe shock; Supraventricular arrhythmia; Impaired cardiac conduction; Stokes-Adams syndrome or severe degrees of sinoatrial, atrioventricular or intraventricular heart block unless the participant has an artificial pacemaker; Severe renal or liver disease; Use of beta blocker medication e.g. propranolol, metoprolol, atenolol, bisoprolol; Use of Anti-arrhythmic medication e.g. amiodarone, flecainide sotalol, digoxin; Electrolyte abnormalities) - No significant and persisting pain component to presentation in preceding 6 months. - Known or suspected malignancy - Pregnancy - Requirement for alternative analgesia regimen - Current/recent use of methadone within 6months of surgery
Outcome results
None listed