Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT03756961

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Pain, Postoperative

Full registry criteria

Inclusion Criteria: -Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site. Exclusion Criteria: * ASA\> III * Cardiovascular disease with bradycardia (\<50 bpm) * Serious liver disease failure * Insufficient knowledge of the Swedish language * Serious untreated psychiatric disease * Neurocognitive dysfunction * Pregnancy * Women of childbearing age without contraception * Malignant disease with expected short survival * Patients treated with opioids for chronic pain * Substance abuse * Hypersensitivity to Oxycodone, Esketamine, Dexmedetomidine, and Lidocaine * Pacemaker or ICD * Inability to fill in questionnaires * Decline participation,

Treatments and study arms

Dexmedetomidine

Drug

The intervention group will obtain the pharmacological treatment during both perioperative. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:

Person-centred care (PCC)

Behavioral

The intervention tests non-pharmacological interventions compared to conventional treatment, supplemented by an evidenced-based Person-centred care PCC approach throughout the continuum of the perioperative and until 4 weeks after discharge. This will be part of patients in Phase 2

Esketamine

Drug

The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:

Lidocaine

Drug

Transcutaneous Nerve Stimulation (TENS)

Device

The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.

Remifentanil

Drug

The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.

Desflurane

Drug

The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia

Propofol

Drug

The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia

Oxycodone

Drug

The control group receives Oxycodone as the routine pain management drug post-operative.

Primary outcomes

Difference in post-operative pain from admission to the post-anesthesia care unit (PACO) to discharge from the PACO unit to the surgical ward.From date of randomization, difference in NRS will be assessed as the change in NRS from arrival (20 minutes after arrival) to the post-anesthesia care unit(PACU) after the surgery, to the time of discharge ( 4 hour) from the PACU to the surgical ward

Post-operative phase until discharge to the surgical ward. Pain assessed according to change in NRS (numeric rating scale). NRS (numeric rating scale for pain), (ranging from 0-10, "no pain" vs. "worst imagined pain").

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Sahlgrenska University hospital/ Östra hopsital🇸🇪 Gothenburg, VG, Sweden

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Axel Wolf, RN/MBA/PhDContact

Email · Call +46709355364

Sven-Egron Thörn, MD/PhDContact

Email · Call +46 31-343 49 03

Lindesberg Hospital🇸🇪 Lindesberg, Region Örebro, Sweden

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Henrik Öhström, MDContact

Email · Call +4619-602 03 56‬