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Effects of an Opioid Sparing Care Pathway for Patients undergoing Obesity Surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505934-86-00
Enrollment
220
Registered
2024-01-31
Start date
2019-03-26
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Pain, postoperative, Obesity

Brief summary

No difference in patient-reported pain score according to NRS (Numeric Rating Scale, 0-10), calculated as a deviation of one scale step within the NRS scale, between the intervention group patients compared to conventional treatment (control group) postoperatively. NRS (numeric rating scale for pain) during the last 24 hours (scale 0-10, 'no pain' vs. 'worst imaginable pain').

Detailed description

An opioid-sparing treatment provides improved combined outcomes (composite score) consisting of 1) Self-Efficacy, 2) Postoperative Quality of Recovery Scale (PQRS), hospital readmission, or death at 3 months compared to conventional treatment., An opioid-sparing treatment results in reduced opioid consumption during the peri- and postoperative period until discharge to the ward compared to conventional treatment., An opioid-sparing treatment results in reduced opioid consumption throughout the hospital stay compared to conventional treatment., An opioid-sparing treatment results in decreased pain experience according to the Numeric Rating Scale (NRS) at 3 months and 6 months compared to conventional treatment., An opioid-sparing treatment leads to earlier recovery after surgery measured with PQRS compared to conventional treatment postoperatively (20 minutes, 40 minutes), during hospitalization (24-72 hours), and thereafter (14 days, 30 days, 3 months, 6 months, 12 months, and 24 months)., An opioid-sparing treatment increases confidence in coping with unexpected events measured with the General Self-Efficacy Scale compared to conventional treatment after the in-hospital period (3 months, 6 months, 12 months, 24 months)., An opioid-sparing treatment improves quality of life measured with RAND-36 and EQ5D compared to conventional treatment after the in-hospital period (3 months, 6 months, 12 months, 24 months)., An opioid-sparing treatment results in equivalent length of hospital stay compared to conventional treatment during the in-hospital period., Mapping of long-term prescription of analgesic drugs. Does an opioid-sparing treatment impact the long-term use of analgesic medications.

Interventions

DRUGESKETAMINE
DRUGDEXMEDETOMIDINE

Sponsors

Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
No difference in patient-reported pain score according to NRS (Numeric Rating Scale, 0-10), calculated as a deviation of one scale step within the NRS scale, between the intervention group patients compared to conventional treatment (control group) postoperatively. NRS (numeric rating scale for pain) during the last 24 hours (scale 0-10, 'no pain' vs. 'worst imaginable pain').

Secondary

MeasureTime frame
An opioid-sparing treatment provides improved combined outcomes (composite score) consisting of 1) Self-Efficacy, 2) Postoperative Quality of Recovery Scale (PQRS), hospital readmission, or death at 3 months compared to conventional treatment., An opioid-sparing treatment results in reduced opioid consumption during the peri- and postoperative period until discharge to the ward compared to conventional treatment., An opioid-sparing treatment results in reduced opioid consumption throughout the hospital stay compared to conventional treatment., An opioid-sparing treatment results in decreased pain experience according to the Numeric Rating Scale (NRS) at 3 months and 6 months compared to conventional treatment., An opioid-sparing treatment leads to earlier recovery after surgery measured with PQRS compared to conventional treatment postoperatively (20 minutes, 40 minutes), during hospitalization (24-72 hours), and thereafter (14 days, 30 days, 3 months, 6 months, 12 months, and 24 month

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026