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

ConditionsObesity Pain, Postoperative

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorGöteborg University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

ASA> III

Cardiovascular disease with bradycardia (<50 bpm)

Serious liver disease failure

Insufficient knowledge of the Swedish language

Trial design

Design model

Parallel

Treatments tested in this trial

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
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.
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.

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: ControlActive comparator 4 interventions

Group B: InterventionExperimental treatment 7 interventions

Trial outcomes

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.

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").

Time frame

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

Secondary outcomes

Recovery after surgery

Investigating recovery after surgery measured with the The Post-operative Quality of Recovery Scale (PostopQRS) compared with conventional postoperative therapy. PostopQRS: Is a validated 5-dimensional instrument (Physiology, Nociception, Emotion, Cognition, ADL) in addition to questions about patient satisfaction. The scoring of recovery is 'return to baseline values or better' which requires a change score ≥ 0 for each question. The postoperative value for each test ( Cognition has a 2 scale tolerance due to day-to-day variation) is subtracted from the baseline value, and if no difference, then the patient is recovered.

Time frame

(20 min, 40 min), during hospitalization (24 hours-72 hours) and afterwards (14 days, 30 days, three months, six months, 12 months and 24 months)

Average opioid consumption perioperative

Investigating opioid consumption during the peri- and post-operative care period compared with conventional treatment until discharge from the hospital and up to 24 months discharge.

Time frame

From the start of the Peri-operative phase (start of surgery) until discharge from hospital ( index stay), up to 24 months post-discharge

Length of hospital stay

Length of indexed hospital stays calculated as the mean length in days from admission to discharge

Time frame

Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days

Change in general Self-Efficacy

Investigating patient change in self-efficacy, measured with the General Self-Efficacy Scale (GSES). GSES is a validated questionnaire that contains 10 questions about the person's experiences of trust in his / her ability to handle difficult situations. The patient is asked to estimate his ability on a 4-point scale (1 not true) to 4 (true). The 10 answers are summed and a mean is calculated. Higher scores are better.

Time frame

3 months, six months, 12 months, 24 months.

Other outcomes

Economic evaluation

Performing cost-utility analysis/ cost-effectiveness

Time frame

During hospital stay and up to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Göteborg University

Lead sponsor

Source ClinicalTrials.gov

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