Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-04 @ 8:27 PM
Study NCT ID:
NCT01720433
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial
Sponsor:
Northampton General Hospital NHS Trust
Organization:
Study Overview
Official Title:
Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: