Condition category
Surgery
Date applied
25/09/2017
Date assigned
08/11/2017
Last edited
03/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Operations for gallstone disease are still sometimes painful. It can cause pain both in the upper abdomen (upper stomach) but also in the shoulder. Research has shown that the intra-abdominal pressure and the residual (left over) CO2 gas (used to provide space in the abdomen to do the operation by minimal invasive surgery) can lead to more pain after surgery. The aim of the study is to look if the pain can be reduced by manually removing the residual CO2 gas by a pulmonary recruitment manoeuver. This manoeuver puts pressure in the lungs to then deflate the abdomen by evacuating the CO2 out of the abdomen via the surgical incisions.

Who can participate?
Adults aged 18 and older who are undergoing elective surgery for gall stone removals.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive their surgical procedure done to the standard level of care. Those in the second group receive the pulmonary recruitment manoeuvre at the end of surgery. Participants are followed up after the surgery during their hospital stay for pain levels, nausea and vomiting. Participants receive a telephone call 48 hours after surgery to assess the quality of their recovery.

What are the possible benefits and risks of participating?
There are no benefits or risks for the patients.

Where is the study run from?
AZ Groeninge (Belgium)

When is the study starting and how long is it expected to run for?
December 2014 to March 2017

Who is funding the study?
Dienst Anesthesie AZ Groeninge (Belgium)

Who is the main contact?
Dr Isabelle Casier

Trial website

Contact information

Type

Public

Primary contact

Dr Isabelle Casier

ORCID ID

Contact details

Hospital AZ Groeninge Kortrijk
President Kennedylaan 4
Kortrijk
8500
Belgium

Additional identifiers

EudraCT number

2014-005442-22

ClinicalTrials.gov number

Protocol/serial number

AZGS2014160

Study information

Scientific title

The effect of low pressure pneumoperitoneum and pulmonary recruitment maneuver on postoperative pain after laparoscopic cholecystectomy

Acronym

Study hypothesis

Hypothesis:
The addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain.

Ethics approval

Ethics board AZ Groeninge Kortrijk, 31/03/2015, ref: 1510

Study design

Prospective randomized controlled single blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See additional files in Dutch and French

Condition

Optimalisation of pain relief after laparoscopic cholecystectomy

Intervention

Low pressure pneumoperitoneum in all patiënts
Pulmonary recruitment maneuver at the end of the surgery in 1 of the 2 groups

Participants are randomly allocated to one of two groups:
Group 1: Control group
Group 2: Intervention group
Randomisation is done beforehand using the website: ‘www.randomization.com’. Randomisation is blind to the participations as they will not know which group they have been allocated to. The anesthesiologist and surgeon do know which group because a recruitment manoeuver can’t be blinded.

All the patients require a laparoscopic cholecystectomy for gall stone disease. The laparoscopy is performed with a low pressure pneumoperitoneum (8-10mmHg). Those in the second group receive a pulmonary recruitment maneuver at the end of surgery. Those in the first group receive the standard level of care.

The recruitment manoeuver is done by an anesthesiologist. Patient was placed in 30° Trendelenburg position, the trocars were fully open to allow CO2 removal. The anesthesiologist gives two manual pulmonary inflation to a maximum pressure of 40cmH2O. Each one of the inflations takes five seconds.

The follow-up was done in the recovery room and at the nursing department during the length of hospitalisation (+/-36 hours). The following parameters are recorded for each group: VAS (visual analogue scale) pain score, need of pain killer, nausea and vomiting.

48 hours after surgery, a quality of recovery is measured by a questionnaire answered by telephone.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Pain relief during the first 24 hours is measured using the VAS (visual analogue scale) at fixed time point: 0-1-6-12-18-24 hours postoperatively.

Secondary outcome measures

1. Total analgesic use during the first 24 hours is measured: the amount of using/needing painkilling during hospitalisation (difference in need of morphine sulphate and tramadol IV (in milligram))
2. Recovery after 48 hours is measured using the postoperative 15-item patient-rated quality of recovery questionnaire by telephone call
3. Nausea and vomiting is measured using patient personal experience
4. Length of hospital stay is measured using time in hours
5. Requirement for increased pressure during surgery is measured using: the place in the abdomen that is required to operated

Overall trial start date

01/12/2014

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients for elective laparoscopic surgery for gall stone disease
2. ASA I and II
3. More than 18 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Refusal to give consent
2. Cholecystitis
3. BMI above 35
4. Intolerance to one of the pain medication
5. Pregnancy

Recruitment start date

26/05/2015

Recruitment end date

20/06/2016

Locations

Countries of recruitment

Belgium

Trial participating centre

AZ Groeninge
President Kennedylaan 4
Kortrijk
8500
Belgium

Sponsor information

Organisation

AZ Groeninge Dienst Anesthesie

Sponsor details

AZ Groeninge
Pres Kennedylaan 4
Kortrijk
8500
Belgium

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Dienst Anesthesie AZ Groeninge

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from isabelle.casier@azgroeninge.be

Intention to publish date

01/05/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes