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Clinical Trial Summary

The opioid consumption has exploded in the western world 1, 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.


Clinical Trial Description

Aim 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. The aim will be investigated by a prospective, randomized, non-blinded, non-commercial single site study (Nov 2018-Dec 2022), approved by the Swedish Medicines Agency (EudraCT 2017003830-97) and the ethical review board (DNR 1006-17).

Hypothesis

1. An opioid-free care pathway provides non-inferior pain relief as the conventional care with opioids during the post-operative phase.

Primary outcomes "No difference in pain (NRS pain (0-10) between opioid-free intervention compared to conventional postoperative treatment (control group) during the post-operative phase until discharge to the surgical ward.

Secondary outcome "An opioid-free treatment provides improved combined outcomes (composite score) consisting of 1) General Self-Efficacy Scale, 2) Postop Quality of Recovery Scale (PostopQRS), hospital rehospitalization or death compared to conventional treatment after three months.

"An opioid-free treatment improves recovery after surgery measured with the PostopQRS compared with conventional postoperative therapy (20 min, 40 min), during hospitalization (24 hours, 48 hours) and afterward (14 days, 30 days, three months, six months, 12 months and 24 months).

"An opioid-free treatment results in reduced opioid consumption during the post-operative care period compared with conventional treatment.

"An opioid-free treatment provides similar care time compared with conventional therapy during hospitalization.

"An opioid-free treatment improves self-efficacy, measured with the General Self-Efficacy Scale compared to conventional treatment at three months, six months, 12 months, 24 months.

"An opioid-free treatment provides increased quality of life measured with the RAND-36 as well as EQ5D compared to conventional therapy during hospitalization (3 months, six months, 12 months, 24 months).

"An opioid-free treatment provides increased patient experience and satisfaction, measured with the PPE-15 and PostopQRS compared to conventional therapy during hospitalization (2 weeks, three months, six months)

"Mapping the long-term prescription and usage pattern of analgesic drugs between the intervention group and conventional group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03756961
Study type Interventional
Source Göteborg University
Contact Axel Wolf, RN, PhD
Phone 0046317866034
Email axel.wolf@gu.se
Status Not yet recruiting
Phase N/A
Start date December 1, 2018
Completion date December 31, 2023

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