None listed
Conditions
Brief summary
Improving surgical and pain relief techniques in laparocopic cholecystectomy has been exhaustively studied. However, in contrast to that, strongly contradicting evidence exists. This study seeks to examine if changes in surgical technique may be able to lessen the impact of surgery on health, by minimising the surgical insult and therefore facilitating an earlier discharge from hospital.
Interventions
-Low pressure (7-10mmHg), warmed (37 degrees Celsius) and humidified carbon dioxide (98% relative humidity)-pneumoperitoneum during the operative procedure for approximately 40-60 minutes. Procedure takes approximately 1 hour with or without interventions.
-The use of instilled intraperitoneal local anaesthetic 2mg/kg of 0.5% bupivacaine- prior to the removal of the gallbladder . This is in addition to the local anaesthetic infiltration into laparoscopic port sites using 2mg/kg bupivacaine give
-Low pressure (7-10mmHg), warmed (37 degrees Celsius) and humidified carbon dioxide (98% relative humidity)-pneumoperitoneum during the operative procedure for approximately 40-60 minutes. Procedure takes approximately 1 hour with or without interventions. -The use of instilled intraperitoneal local anaesthetic 2mg/kg of 0.5% bupivacaine- prior to the removal of the gallbladder . This is in addition to the local anaesthetic infiltration into laparoscopic port sites using 2mg/kg bupivacaine given prior to port placement. -An anaesthetic lung recruitment manoeuvre of delivering a large breath via the endotracheal tube by the Anaesthestist at the end of the operative procedure prior to reversal of anaesthesia.
Sponsors
Hunter New England Local Health District
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 No maximum
Healthy volunteers
No
Inclusion criteria
All English-speaking patients 18 years and over undergoing elective laparoscopic cholecystectomy at participating institutions.
Exclusion criteria
-Are unable to give written informed consent to take part in the study, -Patients who require the use of a trained healthcare interpreter to be able to understand study information. -Unable to carry out spirometry or mobility assessment -Long term opioid use -BMI > 35kg/m2 -Significant lung disease with FEV1 <1.25L -Previous upper abdominal laparotomy suggestive of prolonged, complex upper abdominal surgery/ adhesiolysis -Past abdominoplasty, abdominal wall reconstruction, component separation -Known allergies to local anaesthetic or opioid agents. -Known chronic pain syndrome -Diagnosed neuromuscular disease -Previous necrotizing pancreatitis -Known stage 4 chronic kidney disease of eGFR 15-29ml/min.
Outcome results
None listed