None listed
Conditions
Brief summary
Pain after surgery can impact your recovery and there has been a lot of research into what we can do to improve your pain. After a laparoscopy for a hysterectomy or endometriosis, you would normally have regular paracetamol and an anti-inflammatory called diclofenac, and some opioid medication called oxycodone for when your pain is particularly bad. We are conducting a trial to determine whether placing some local anaesthetic in the pelvis at the end of your laparoscopic hysterectomy or excision of endometriosis can improve your pain in the first 24 hours after surgery, in addition to the standard medications that you would use for pain. Approximately 100 women will be involved in the study. You will be randomly allocated to either receiving the local anaesthetic, or receiving a placebo (something that looks exactly like the local anaesthetic but doesn’t have any medicine in it). Neither we, as your doctors, or you will know which allocation you receive, and we cannot decide which allocation you receive if you agree to take part in the study. After your surgery, we will ask you to tell us about your pain using what is called a ‘visual analogue scale’ at 1, 4, 8 and 24 hrs postoperative. You will need to fill in a paper questionnaire at home. We will also ask you to record how much pain relief you need during the first 8, 24 and 72 hrs. This form can either be emailed or posted back to us via the envelope provided. A member of the research team will call you at 72 hrs and 2 weeks postoperative to evaluate for any complications. We will be conducting the study at the Townsville University Hospital and the Mater Hospital in Pimlico.
Interventions
This is a randomised control trial with two arms, intervention and placebo. The intervention is instillation of a single dose of 2.5mg/kg of Ropivacaine into the pelvis at the completion of laparoscopic hysterectomy or three compartment endometriosis resection. The maximum dose administered to a patient will be 300mg and the fluid will be instilled into the pelvis via a laparoscopic port. The placebo arm will receive a matched volume per kg of normal saline into the pelvic. The intervention/plac
This is a randomised control trial with two arms, intervention and placebo. The intervention is instillation of a single dose of 2.5mg/kg of Ropivacaine into the pelvis at the completion of laparoscopic hysterectomy or three compartment endometriosis resection. The maximum dose administered to a patient will be 300mg and the fluid will be instilled into the pelvis via a laparoscopic port. The placebo arm will receive a matched volume per kg of normal saline into the pelvic. The intervention/placebo will be administered by the research team.
Sponsors
Vanessa Lusink
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 No maximum
Healthy volunteers
No
Inclusion criteria
Age over 18. Surgery for - laparoscopic hysterectomy or resection of endometriosis of sufficient volume to result in 3 x compartment resection.
Exclusion criteria
Severe liver dysfunction Severe kidney dysfunction Allergy to Ropivacaine Pre-existing pain syndrome with daily opioid use of > 3 months duration.
Outcome results
None listed