Aim of this pilot study is to determine which intervention groups are feasible in a larger trial which aims to a compare postoperative pain and complication rates in moderate versus deep neuromuscular blockade, and normal versus low intra-abdominal…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Quality of surgical field (Graded on the Leiden Surgical Rating Scale), to
be scored directly after sign out procedure. 2. Postoperative pain;
questionnaire until 7 days postoperatively, length of hospital stay, usage of
analgesia.
Secondary outcome
Complications during surgery or within 1 month postoperatively; i.a. bleeding,
leakage.
Background summary
Laparoscopy is the golden standard in bariatric surgery. General guidelines of
laparoscopy recommend to operate using the minimum intra-abdominal pressure
needed for a good overview. For the obese, higher pressures are often used to
create a surgical field of sufficient quality. However, studies have shown that
decreased intraabdominal pressure might reduce postoperative pain. Therefore it
would be desirable to operate with a low-pressure, maintaining a good quality
of surgical field and without increasing the number of adverse events. Up until
now, there is no consensus which combinations of pressure and block type are
optimal in obese patients.
Study objective
Aim of this pilot study is to determine which intervention groups are feasible
in a larger trial which aims to a compare postoperative pain and complication
rates in moderate versus deep neuromuscular blockade, and normal versus low
intra-abdominal pressure.
Study design
This is a double-blinded, randomized controlled pilot study, to test
feasibility of a planned trial. We will be comparing 4 groups of 15 patients,
undergoing laparoscopic bariatric surgery with deep neuromuscular block versus
normal neuromuscular block and normal-pressure pneumoperitoneum versus
low-pressure pneumoperitoneum in a 2x2 table design. Patient and surgeon are
blinded. Anesthesiologist is not blinded in order to control the depth of the
neuromuscular block and pressure. The study will be performed in a large
secondary hospital (Franciscus Gasthuis & Vlietland).
Intervention
Patients will receive either deep neuromuscular block or moderate neuromuscular
block, measured with PTC. They will be operated under either normal pressure
pneumoperitoneum (20 mmHg in our centre) versus low pressure pneumoperitoneum
(12 mmHg). In case of unacceptable surgical conditions, either neuromuscular
block or pneumoperitoneum will be increased, depending on the group in which
the patient is randomised.
Study burden and risks
Patients will be asked to keep a pain diary during the first week after surgery
and will receive an extra phone call from the investigator to inform on their
wellbeing on day 3. The risk of the investigational treatment is possible
longer duration of surgery due to less overview. Benefit is the expected lower
pain score after surgery. We conclude that the benefits of the interventions
outweigh the minor risks.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
Primary bariatric procedure; good command of the Dutch language.
Exclusion criteria
Allergies for used medication, neuromuscular comorbidities, a medical history of pain disorders such as ACNES, fibromyalgia or CRPS, or no informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64025.101.17 |
| OMON | NL-OMON26521 |