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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achal Khanna, Northampton General Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01720433
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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 Intervention
Post-operative Pain
Procedure: intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.

Further study details as provided by Northampton General Hospital NHS Trust:

Primary Outcome Measures:
  • pain scores at varying time points pot operatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.')


Enrollment: 127
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01720433

Locations
United Kingdom
Northampton General Hopsital
Northampton, Northamptonshire, United Kingdom, NN15BD
Sponsors and Collaborators
Northampton General Hospital NHS Trust
Investigators
Principal Investigator: Achal Khanna, MRCSEd Northampton General Hospital Northampton England
  More Information

No publications provided by Northampton General Hospital NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Achal Khanna, Mr Achal Khanna Specialist Registrar - Surgery, Northampton General Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01720433     History of Changes
Other Study ID Numbers: lap pain trial NGH
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: United Kingdom: Department of Health

Keywords provided by Northampton General Hospital NHS Trust:
laparoscopic pain prospective blinded trial

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014