NCT01720433

Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial

Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Northampton General Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as causes of post-operative morbidity. This prospective, double-blind, randomized controlled trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by implementing a simple intra-operative technique. Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be randomized to either the current standard (control group) or to receive an intervention to remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the end of the operation, by placing the patient in the Trendelenburg position and utilising a pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of 60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of the procedure by passive decompression via the open operative ports.

Detailed description

This trial recruited 76 randomly assigned patients, 37 in the intervention group and 39 in the control group. The overall post-surgery pain scores, as analysed by two-way ANOVA, were significantly lower in the intervention group (P=0.0019). On Bonferroni post-tests both 12 hour (P\<0.01) and 24-hour (P\<0.01) pain scores were significantly lower in the intervention group.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
PROCEDURE	intervention	The patient was placed in the Trendelenburg position (30°) and two manual lung inflations to a maximum pressure of 60 cm H2O for five seconds, with the valves on the operative ports fully open.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-11-02
• Last updated: 2012-11-02

Locations

1 site across 1 country: United Kingdom