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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

26 Mar 2019 → ongoing

Decision date (initial)

2024-01-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-505934-86-00

EudraCT number

2017-003830-97

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Diagnosis, Efficacy, Therapy

To evaluate the effects of opioid sparing care pathways compared to conventional opioid-based treatment for pain relief, opioid consumption, recovery after surgery, self-efficacy and health economy in patients undergoing obesity surgery.

Conditions and MedDRA coding

Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site.
2. Give informed consent to participate in the study.

Exclusion criteria 15

1. ASA> III
2. Cardiovascular disease with bradycardia (<50 bpm)
3. Serious liver disease failure
4. Insufficient knowledge of the Swedish language
5. Serious untreated psychiatric disease
6. Neurocognitive dysfunction
7. Pregnancy
8. Women of childbearing age without contraception
9. Malignant disease with expected short survival
10. Patients treated with opioids for chronic pain
11. Substance abuse
12. Hypersensitivity to Oxycodone, Esketamine, Dexmedetomidine, and Lidocaine
13. Pacemaker or ICD
14. Inability to fill in questionnaires
15. Decline participation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 10

1. 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.
2. An opioid-sparing treatment results in reduced opioid consumption during the peri- and postoperative period until discharge to the ward compared to conventional treatment.
3. An opioid-sparing treatment results in reduced opioid consumption throughout the hospital stay compared to conventional treatment.
4. 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.
5. 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).
6. 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).
7. 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).
8. An opioid-sparing treatment results in equivalent length of hospital stay compared to conventional treatment during the in-hospital period.
9. Mapping of long-term prescription of analgesic drugs. Does an opioid-sparing treatment impact the long-term use of analgesic medications.
10. Cost-minimization analysis/cost effectiveness analysis from a healthcare perspective. Micro-costing assessment of perioperative and surgery ward resource use, including healthcare consumption up to 6 months postoperatively.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Axel

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Axel

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications