Obesity Clinical Trial
— OS-PCCOfficial title:
Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery
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, 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 (EudraCT 2017003830-97) and the ethical review board (DNR 1006-17).
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2027 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University hospital/ Östra hopsital | Gothenburg | VG |
Sweden | Lindesberg Hospital | Lindesberg | Region Örebro |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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"). | 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 | 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. |
(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) | |
Secondary | 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. | From the start of the Peri-operative phase (start of surgery) until discharge from hospital ( index stay), up to 24 months post-discharge | |
Secondary | Length of hospital stay | Length of indexed hospital stays calculated as the mean length in days from admission to discharge | Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days | |
Secondary | 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. |
3 months, six months, 12 months, 24 months. | |
Secondary | Change in Quality of Life | Investigating the quality of life measured with the RAND-36 RAND-36: The RAND-36 is a health-related quality of life (HRQoL) It is comprised of 36 items assessing eight areas: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Each item is scored 0-100, and are than summarized. 0 is low, 100 is the highest score to get. |
(3 months, six months, 12 months, 24 months) | |
Secondary | Exploring patient experience | Investigating patient experience and satisfaction during the hospital stay, measured with the PPE-15, a 15 item questionnaire. The PPE15 is a validated short version of The Picker Care experience survey (40 item). Each item has response alternatives ranging from no problem, some problem, problem. Each response is coded either as "a problem" ( problem, some problem) or as "no problem". Problem is scored as=1, no problem=0. The mean is calculated both on item level and as a total score. |
2 weeks after hospital discharge | |
Secondary | Change in health status | Investigating the change in health status measured with the EuroQol 5 dimension (EQ5D). EQ-5D is a standardized instrument for measuring generic health status, covering five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 responses: no problems, some problems, and extreme problems. This response results into a number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. |
(3 months, six months, 12 months, 24 months) | |
Secondary | Unplanned re-admission | Investigating re-admission (un-planned) between groups. | From time of surgery up until 24 months post-surgery | |
Secondary | Mortality | Investigating mortality rate between groups. | From time of surgery up until 24 months post-surgery |
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