None listed
Conditions
Brief summary
Effective postoperative pain management continues to be an issue in laparoscopic surgery including gastric bypass. The aim of this study is to evaluate the efficacy of intraperitoneal nebulisation of ropivacaine to reduce post-operative pain in patients undergoing gastric bypass surgery.
Interventions
A prospective double-blinded clinical randomised control trial will be conducted to compare intraperitoneal instillation of ropivacaine to normal saline in 120 patients undergoing bariatric surgery.
The amount of 0.2% ropivacaine used for intra-peritoneal instillation will be administered according to patient weight at 0.5ml/kg. This will be instilled in and around the esophageal hiatus once at the conclusion of the laparoscopic bariatric procedure. Instillation will occur using a mixing cannul
A prospective double-blinded clinical randomised control trial will be conducted to compare intraperitoneal instillation of ropivacaine to normal saline in 120 patients undergoing bariatric surgery. The amount of 0.2% ropivacaine used for intra-peritoneal instillation will be administered according to patient weight at 0.5ml/kg. This will be instilled in and around the esophageal hiatus once at the conclusion of the laparoscopic bariatric procedure. Instillation will occur using a mixing cannula. The amount of ropivacaine will be personalised to each patient by weight to ensure toxic doses are not breached and to accomodate for weight based diffusion variability between patients. The patient's weight will be recorded the day of the intervention and appropriate ml/kg amount of the unidentified drug/saline will be administered. A research nurse will be present to monitor adherence to the specified intervention regimen,
Sponsors
Dr Nicholas Williams
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who are undergoing a laparoscopic bariatric procedure through Riverina Bariatrics
Exclusion criteria
allergy to local anaesthetic, severe cardiovascular disease (congestive heart failure or ischaemic heart disease), chronic renal disease (creatinine clearance <60 mL/h), child-Pugh Score B/C and if the participant declined to participate.
Outcome results
None listed