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Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery

Study acronym: OS-PCC
StatusRecruiting
PhaseNot applicable
Started2019-05-01
View on ClinicalTrials.gov ↗

Amendment history

2026-01-02
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures v8
Primary completion date2027-01-31→2028-05-31
Completion date2027-12-31→2029-12-31
Study description+991 characters
[...] v 2018-Dec 2022), approved by the Swedish Medicines Agency (EudraCTEU-CT 20170038302023-97505934-86-00) and the ethical review board (DNR 1006-17). Hypothesis 1. [...] endpoints: Determine the quality of recovery after surgery 1. No difference in pain (NRS pain (0-10)) between opioid-free [...] e postoperative phase until discharge to the surgical ward. Secondary endpoints: An opioid-freesparing interventiontreatment withprovides orimproved withoutcombined outcomes (Phasescomposite score) consisting of 1) &Self-Efficacy, 2) personPostoperative Quality of Recovery Scale (PQRS), hospital readmission, or de [...] [...]
2024-10-10
minor
Study Status, Contacts/Locations v7
Primary completion date2024-01-31→2027-01-31
2023-08-31
minor
Study Status, Study Description, Study Design, Arms and Interventions v6
Primary completion date2023-12-31→2024-01-31
Completion date2025-12-31→2027-12-31
Study description+1,949 characters
[...] d by a prospective, randomized, non-blinded, non-commercial single sitemulti-centre study(Nov 2018-Dec 2022), approved by the Swedish Medicines [...] care with opioids during the post-operative phase. Primary outcomesendpoints: "Determine the quality of recovery after surgery No difference in pain (NRS pain (0-10)) between opioid-free intervention comparedwith toor without (Phase 1 & 2) person-centred care and conventional postoperative treatment (control group) during the post-operativepostoperative phase until discharge to the surgical ward. Secondary outcome "An opioid-free treatmentintervention [...]
2022-03-15
minor
Study Status v5
Primary completion date2021-12-31→2023-12-31
Completion date2024-12-31→2025-12-31
2020-08-29
minor
Study Identification, Study Status, Study Design, Contacts/Locations v4
Primary completion date2020-12-31→2021-12-31
Completion date2023-12-31→2024-12-31
Study sites1→2
Study title+5 characters
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
Show 3 earlier versions
2019-07-31
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-05-07→confirmed 2019-05-01
Study sites0→1
2019-04-29
minor
Study Status v2
Start date2019-04-01→2019-05-07
2019-02-12
minor
Study Status v1
Start date2018-12-01→2019-04-01
2018-11-27
minor
Original filing
3,523 trials monitored
See 133 trials at risk
The opioid consumption has exploded in the western world, and for some patient populations such as obese patients, patients with sleep apnoea or patients undergoing cancer treatment, opioid-sparing/ opioid-free strategies could have positive effects on outcomes. Studies suggest that opioids could have opioid-induced immunosuppression, induce chronic post-operative pain syndrome and hyperalgesia in addition to the more well-known side effects such as respiratory depression, nausea, bladder, and bowel dysfunction. Hence, new studies are needed on the impact of person-centered care programs that combine pharmaceutical and non-pharmaceutical strategies to reduce the adverse short and long-term effects of opioid therapy. The overall aim is to evaluate the short-, medium- and long-term effects of opioid-free care pathways with or without person-centred care compared to conventional opioid-based treatment in patients undergoing obesity surgery. Specific aims 1. Determine the effects of opioid-free care with or without person-centred care compared with conventional opioid-based general anaesthesia on the cognitive and physical quality of recovery after surgery up to 24 months after surgery (short-term: postoperative to discharge, medium-term: 14 days, 3 months, long-term: 6 months, 12 months and 24 months). 2. Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care. 3. Map the impact of opioid-free anaesthesia (with and without person-centred care) on the usage of opioids up to 24 months after hospital discharge. 4. Explore the patients' experience of quality of life, economic evaluations, self-efficacy and recovery after surgery in opioid-free care with or without person-centred care during the first year post-surgery. The aims will be evaluated by a prospective, randomized, non-blinded, non-commercial multi-centre study (Nov 2018-Dec 2022) approved by the Swedish Medicines Agency (EU-CT 2023-505934-86-00) and the ethical review board (DNR 1006-17).
Trial Details
NCT Number NCT03756961
Lead Sponsor Göteborg University
Conditions Obesity, Pain, Postoperative
Enrollment 220 participants
Start Date 2019-05-01
Primary Completion 2028-05-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-07