Elliot Gin1, Darren Lowen2, Mark Tacey3,4, Russell Hodgson5,6. 1. Department of Surgery, Northern Health, 185 Cooper St, Epping, VIC, Australia. 2. Department of Anaesthetics, Northern Health, Epping, Australia. 3. Department of Research, Northern Health, Epping, Australia. 4. Department of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Australia. 5. Department of Surgery, Northern Health, 185 Cooper St, Epping, VIC, Australia. russell.hodgson@nh.org.au. 6. Department of Surgery, University of Melbourne, Epping, Australia. russell.hodgson@nh.org.au.
Abstract
BACKGROUND:Laparoscopic surgery is regarded as the gold standard for the surgical management of cholelithiasis. To improve post-operative pain, low-pressure laparoscopic cholecystectomies (LPLC) have been trialed. A recent systematic review found that LPLC reduced pain; however, many of the randomised control trials were at a high risk of bias and the overall quality of evidence was low. METHODS:One hundred patients undergoing elective laparoscopic cholecystectomy were randomised to a LPLC (8 mmHg) or a standard pressure laparoscopic cholecystectomy (12 mmHg) (SPLC) with surgeons and anaesthetists blinded to the pressure. Pressures were increased if vision was compromised. Primary outcomes were post-operative pain and analgesia requirements at 4-6 h and 24 h. RESULTS:Intra-operative visibility was significantly reduced in LPLC (p<0.01) resulting in a higher number of operations requiring the pressure to be increased (29% vs 8%, p=0.010); however, there were no differences in length of operation or post-operative outcomes. Pain scores were comparable at all time points across all pressures; however, recovery room fentanyl requirement was more than four times higher when comparing 8 to 12 mmHg (12.5mcg vs 60mcg, p=0.047). Nausea and vomiting was also higher when comparing these pressures (0/36 vs 7/60, p=0.033). Interestingly, when surgeons estimated the operating pressure, they were correct in only 69% of cases. CONCLUSION: Although pain scores were similar, there was a significant reduction in fentanyl requirement and nausea/vomiting in LPLC. Although LPLC compromised intra-operative visibility requiring increased pressure in some cases, there was no difference in complications, suggesting LPLC is safe and beneficial to attempt in all patients. TRIAL REGISTRATION: Registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12619000205134).
RCT Entities:
BACKGROUND: Laparoscopic surgery is regarded as the gold standard for the surgical management of cholelithiasis. To improve post-operative pain, low-pressure laparoscopic cholecystectomies (LPLC) have been trialed. A recent systematic review found that LPLC reduced pain; however, many of the randomised control trials were at a high risk of bias and the overall quality of evidence was low. METHODS: One hundred patients undergoing elective laparoscopic cholecystectomy were randomised to a LPLC (8 mmHg) or a standard pressure laparoscopic cholecystectomy (12 mmHg) (SPLC) with surgeons and anaesthetists blinded to the pressure. Pressures were increased if vision was compromised. Primary outcomes were post-operative pain and analgesia requirements at 4-6 h and 24 h. RESULTS: Intra-operative visibility was significantly reduced in LPLC (p<0.01) resulting in a higher number of operations requiring the pressure to be increased (29% vs 8%, p=0.010); however, there were no differences in length of operation or post-operative outcomes. Pain scores were comparable at all time points across all pressures; however, recovery room fentanyl requirement was more than four times higher when comparing 8 to 12 mmHg (12.5mcg vs 60mcg, p=0.047). Nausea and vomiting was also higher when comparing these pressures (0/36 vs 7/60, p=0.033). Interestingly, when surgeons estimated the operating pressure, they were correct in only 69% of cases. CONCLUSION: Although pain scores were similar, there was a significant reduction in fentanyl requirement and nausea/vomiting in LPLC. Although LPLC compromised intra-operative visibility requiring increased pressure in some cases, there was no difference in complications, suggesting LPLC is safe and beneficial to attempt in all patients. TRIAL REGISTRATION: Registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12619000205134).