Back to resultsReduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
intervention
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Pain focused on measuring laparoscopic pain prospective blinded trial
Eligibility Criteria
Inclusion Criteria:
- All patients were recruited from a single Consultant's surgical clinic at the same District General Hospital between August 2010 and February 2012. This study was approved by the local ethics committee (National Research Ethics Service REC ref: 09/H0405/65) and informed consent was obtained from all patients after they had the opportunity to study information leaflets that were also given to them. The trial was designed as a prospectively randomized and double blind trial with a 1:1 (control:intervention) allocation.
The inclusion criteria was all adults with an American Society of Anesthesiologists (ASA) physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal preperitoneal procedure (TAP). All procedures and data collection occurred at a District General Hospital.
Exclusion Criteria:
The pre-operative exclusion criteria included patients younger than 18 years, those who refused to give consent, those that had an inability to understand the research questionnaire and pregnancy. Patients who were found to require additional procedures, for example a conversion to open surgery, were excluded from the study prior to randomization.
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Sites / Locations
- Northampton General Hopsital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
control arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
pain scores at varying time points pot operatively
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.')
Secondary Outcome Measures
Full Information
NCT ID
NCT01720433
First Posted
October 29, 2012
Last Updated
October 31, 2012
Sponsor
Northampton General Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01720433
Brief Title
Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial
Official Title
Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northampton General Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
laparoscopic pain prospective blinded trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
intervention
Other Intervention Name(s)
pulmonary recruitment maneouvre
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain scores at varying time points pot operatively
Description
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.')
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients were recruited from a single Consultant's surgical clinic at the same District General Hospital between August 2010 and February 2012. This study was approved by the local ethics committee (National Research Ethics Service REC ref: 09/H0405/65) and informed consent was obtained from all patients after they had the opportunity to study information leaflets that were also given to them. The trial was designed as a prospectively randomized and double blind trial with a 1:1 (control:intervention) allocation.
The inclusion criteria was all adults with an American Society of Anesthesiologists (ASA) physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal preperitoneal procedure (TAP). All procedures and data collection occurred at a District General Hospital.
Exclusion Criteria:
The pre-operative exclusion criteria included patients younger than 18 years, those who refused to give consent, those that had an inability to understand the research questionnaire and pregnancy. Patients who were found to require additional procedures, for example a conversion to open surgery, were excluded from the study prior to randomization.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Achal Khanna, MRCSEd
Organizational Affiliation
Northampton General Hospital Northampton England
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northampton General Hopsital
City
Northampton
State/Province
Northamptonshire
ZIP/Postal Code
NN15BD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23939841
Citation
Khanna A, Sezen E, Barlow A, Rayt H, Finch JG. Randomized clinical trial of a simple pulmonary recruitment manoeuvre to reduce pain after laparoscopy. Br J Surg. 2013 Sep;100(10):1290-4. doi: 10.1002/bjs.9202.
Results Reference
derived
Learn more about this trial
Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial
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