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

NCT ID: NCT01720433

Last Updated: 2012-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-02-29

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.

Conditions

Post-operative Pain

Keywords

laparoscopic pain prospective blinded trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

intervention

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

pulmonary recruitment maneouvre

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.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northampton General Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Achal Khanna

Mr Achal Khanna Specialist Registrar - Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Achal Khanna, MRCSEd

Role: PRINCIPAL_INVESTIGATOR

Northampton General Hospital Northampton England

Locations

Northampton General Hopsital

Northampton, Northamptonshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23939841 (View on PubMed)

Other Identifiers

lap pain trial NGH

Identifier Type: -

Identifier Source: org_study_id