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Ketamine Clinical Trials

A trial to look at whether certain anaesthetic medications can affect post operative pain for women who have surgery for endometriosis

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Id: ACTRN12618001767291

Organisation Name: Jennifer Pontre

Overal Status: Recruiting

Start Date: 03/12/2018

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.

  • Australia
  • chronic pelvic pain
  • endometriosis

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