The effect of low pressure pneumoperitoneum and pulmonary recruitment maneuver on postoperative pain after laparoscopic cholecystectomy
| ISRCTN | ISRCTN17470334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17470334 |
| EudraCT/CTIS number | 2014-005442-22 |
| Secondary identifying numbers | AZGS2014160 |
- Submission date
- 25/09/2017
- Registration date
- 08/11/2017
- Last edited
- 03/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
Hospital AZ Groeninge Kortrijk
President Kennedylaan 4
Kortrijk
8500
Belgium
Study information
| Study design | Prospective randomized controlled single blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | See additional files in Dutch and French |
| Scientific title | The effect of low pressure pneumoperitoneum and pulmonary recruitment maneuver on postoperative pain after laparoscopic cholecystectomy |
| Study objectives | Hypothesis: The addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. |
| Ethics approval(s) | Ethics board AZ Groeninge Kortrijk, 31/03/2015, ref: 1510 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2014 |
| Completion date | 01/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Patients for elective laparoscopic surgery for gall stone disease 2. ASA I and II 3. More than 18 years old |
| Key exclusion criteria | 1. Refusal to give consent 2. Cholecystitis 3. BMI above 35 4. Intolerance to one of the pain medication 5. Pregnancy |
| Date of first enrolment | 26/05/2015 |
| Date of final enrolment | 20/06/2016 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Kortrijk
8500
Belgium
Sponsor information
Hospital/treatment centre
AZ Groeninge
Pres Kennedylaan 4
Kortrijk
8500
Belgium
"ROR" |
https://ror.org/01cz3wf89 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from isabelle.casier@azgroeninge.be |
