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PILOT STUDY PROTOCOL: LOW-PRESSURE PNEUMOPERITONEUM WITH DEEP NEUROMUSCULAR BLOCKADE IN BARIATRIC SURGERY TO REDUCE POSTOPERATIVE PAIN

PILOT STUDY PROTOCOL: LOW-PRESSURE PNEUMOPERITONEUM WITH DEEP NEUROMUSCULAR BLOCKADE IN BARIATRIC SURGERY TO REDUCE POSTOPERATIVE PAIN - Bar-press trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44329
Enrollment
60
Registered
2018-04-10
Start date
2018-08-08
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Morbid) obesity extreme overweight

Interventions

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)

Sponsors

Sint Franciscus Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Primary bariatric procedure; good command of the Dutch language.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Complications during surgery or within 1 month postoperatively; i.a. bleeding, leakage.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)