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ADIPAIN- a prospective, randomized, placebo-controlled study for the use of a continuous wound infiltration in patients who undergo a laparoscopic Roux-Y-gastric bypass.

ADIPAIN- a prospective, randomized, placebo-controlled study for the use of a continuous wound infiltration in patients who undergo a laparoscopic Roux-Y-gastric bypass.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029763
Enrollment
50
Registered
2023-02-16
Start date
2020-03-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Sensation of pain after gastric bypass surgery E66.0

Interventions

Group 1: Group 1 gets a catheter implanted (prepertioneal in the area of the left lateral trocar position) with a initial bolus of 10 ml Bupivacain, after which a continous application of 8ml/h Ropiva

Sponsors

Allgemeinchirurgie Uniklinik Gießen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: -18-70 years -planned for a laparoscopic gastric bypass - patient is reconnaissance capable - german or english speaking

Exclusion criteria

Exclusion criteria: -70 years - patient declines participation -pregnancy - poatient is not reconnaissance capable - allergies against local anaesthetics - infection in the planned localisation of the catheter -massiv adhaesions during the operation -open gatsric bypass -drug addiction - mental retardation - heart failure NYHA >2 - coagulopathy - chronic pain syndrome

Design outcomes

Primary

MeasureTime frame
The Vas-p on the second postoperative day

Secondary

MeasureTime frame
-VAS-assesement on the evening of they operation day, on the morning and the evening of day 1,2,3, and ,if not discherged by then, on day 4 after the operation as well as 2 weeks after the operation -evaluation of the additional need for sysetmic pain relief -evaluation of the ability to mobilize, which was measured via the 6 minute walk test and a fitness bracelet -bedside lung function tests -evaluation of possible surgical site infections and possible catheter associated complications -evaluation of the postoperative inflammatory markers -preoperative ultrasound evaluation of the abdominal wall and the visceral fat -evaluation of the duration of the in-hospital stay and the intensive care-unit

Countries

Germany

Contacts

Public ContactAndreas Hecker

Allgemeinchirurgie Uniklinik Gießen

andreas.hecker@chiru.med.uni-giessen.de0641-98544701

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026