Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01720433|
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : November 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pain||Procedure: intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
In the intervention group, in addition to the above, the patient was placed in the Trendelenburg position (30°) and a pulmonary recruitment maneuver utilized, consisting of two manual inflations to a maximum pressure of 60 cm H2O. This was performed by the Anaesthetist, who held each positive pressure inflation for five seconds, with the valves on the operative ports fully open.
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.
Other Name: pulmonary recruitment maneouvre
No Intervention: control arm
In the control group residual carbon dioxide pneumo-peritoneum was evacuated at the end of the procedure by passively allowing the abdomen to decompress by opening the operative ports.
- pain scores at varying time points pot operatively [ Time Frame: 48 hours ]Pain scores were assessed by the use of a validated visual analogue score (whereby '0' was equivalent to 'no pain' and '10' equivalent to the worst 'conceivable pain.')
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720433
|Northampton General Hopsital|
|Northampton, Northamptonshire, United Kingdom, NN15BD|
|Principal Investigator:||Achal Khanna, MRCSEd||Northampton General Hospital Northampton England|