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
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
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