None listed
Conditions
Brief summary
This is a double blinded prospective randomised pilot study to investigate whether the use of a combination of analgesic medications (ketamine, lignocaine and pregabalin), when combined with conventional general anaesthesia, influences the incidence of chronic pelvic pain in women undergoing surgical management of moderate to severe endometriosis. Chronic pelvic pain (CPP) is common in women with endometriosis, and can develop despite surgical treatment of the disease. CPP is defined as the presence of non-cyclic daily pain of 6 months duration or longer that localizes to the anatomic pelvis and is severe enough to cause functional disability and require medical or surgical treatment. Endometriosis causes pain through a variety of mechanisms including direct compression/infiltration of nerves by the lesions, inflammation, and damage to pelvic nerves during surgery and may lead to changes in the central nervous system which propagate chronic pain. The medications being investigated in this study have potentially beneficial effects in preventing the central nervous system changes which may lead to chronic pelvic pain. Patients will be recruited from the endoscopy and pre-admission clinics and the day of surgery admission unit at King Edward Memorial Hospital. They will be eligible for the study if they have an American Fertility Society Score of 2 or 3 on previous laparoscopy and are scheduled for laparoscopic treatment on endometriosis. At recruitment patients will undergo a visual analogue scale (VAS) assessment for pain and will complete a quality of life (QOL) assessment. Patients will be randomised to either a standard care group who will be managed with a conventional general anaesthesia approach or to the intervention group, who will receive pre-medication with paracetamol and pregabalin, followed by an IV bolus and infusion of lignocaine and ketamine intra-operatively, with regular pregabalin in the post-operative period. The standard care group will receive oral placebos to replace pre-operative paracetamol and pregabalin, and post-operative pregabalin. Repeat pain scores will be recorded on day 1, and repeat pain scores and QOL scores at 6 weeks, 3 months, 6 months and 12 months post-operatively.
Interventions
Pre-op: Pregabalin 75-150 mg orally + Paracetamol 1g orally
During Induction and Maintenance: standard anaesthetic protocol + Ketamine 0.5 mg/kg bolus at induction followed by infusion (0.2 mg/kg/hr) + Lignocaine 1.5 mg/kg bolus followed by infusion (1 mg/kg/hr)
Post-op: Pregabalin 75 mg twice per day orally for 5 days
The approximate duration of the induction/maintenance phase will differ from case to case as it mainly depends on the severity of the endometriosis encountered which will impa
Pre-op: Pregabalin 75-150 mg orally + Paracetamol 1g orally During Induction and Maintenance: standard anaesthetic protocol + Ketamine 0.5 mg/kg bolus at induction followed by infusion (0.2 mg/kg/hr) + Lignocaine 1.5 mg/kg bolus followed by infusion (1 mg/kg/hr) Post-op: Pregabalin 75 mg twice per day orally for 5 days The approximate duration of the induction/maintenance phase will differ from case to case as it mainly depends on the severity of the endometriosis encountered which will impact on the case complexity and therefore the duration. The minimum time would be expected to be around 6o minutes, and the maximum time would be approximately 150 minutes. We will monitor drug adherence via follow up phone call by our trial nurse. Description of full intervention protocol: Pre-operative: Pregabalin 75-150 mg orally (dose at discretion of anaesthetist) Paracetamol 1g orally Intra-operative: Induction and Maintenance: Ketamine 0.5 mg/kg bolus at induction followed by infusion (0.2 mg/kg/hr) Lignocaine 1.5 mg/kg bolus followed by infusion (1 mg/kg/hr) Post operative: Pregabalin 75 mg twice per day orally for 5 days Post operative nausea and vomiting will be treated using the standard King Edward Memorial Hospital Post Operative Nausea and Vomiting protocol.
Sponsors
Jennifer Pontre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
• Women between 18 and 40 years of age who complain of regular significant dysmenorrhea and / or pelvic pain that has persisted for more than 1 year AND • Who have undergone a staging laparoscopy according to the AFS endometriosis score by a gynaecologist and are documented to have an American Fertility Society Score of 2 or 3. o OR have a tertiary level pelvic ultrasound documenting an AFS of 2 or 3 • AND • Planned surgery for treatment of endometriosis
Exclusion criteria
• Contraindication to any of the medications being used in either Group One or Group Two • Surgical procedure other than laparoscopic treatment of endometriosis, check of tubal patency and minor hysteroscopic procedure OR • Active or relapsing pelvic inflammatory disease OR • Poor communication of written and spoken English for informed consent purposes • Less than 18 or more than 40 years of age
Outcome results
None listed