Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery (OS-PCC)

• ClinicalTrials.gov Identifier: NCT03756961
• Recruitment Status: Recruiting
• First Posted: November 28, 2018
• Last Update Posted: September 1, 2020
• Sponsor: Göteborg University
• Information provided by (Responsible Party): Göteborg University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity; Pain, Postoperative	Drug: Dexmedetomidine; Behavioral: Person-centred care (PCC); Drug: Esketamine; Drug: Lidocaine; Device: Transcutaneous Nerve Stimulation (TENS); Drug: Remifentanil; Drug: Desflurane; Drug: Propofol; Drug: Oxycodone	Not Applicable

Detailed 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized, non-blinded, non-commercial multi centre study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery
• Actual Study Start Date: May 1, 2019
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control; Control group: The patients receive the routine based anesthesiological treatment during bariatric surgery (Gastric By-Pass or Sleeve Gastrectomy). It consists of: General anesthesia induction: TCI Remifentanil Cpt 6 ng/ml/ Cp 3.2 ng/m, Propofol 1.5-2 mg/kg iv, Desflurane MAC (0.6-0.8). Maintained by Desflurane MAC (0.6-0.8) adjusted via BIS (40-60) and Remifentanil Cp 4-10 ng/ml. Post-operative pain management: Oxycodone 2.5 mg iv if the pain is rated by patient NRS ≧3. Paracetamol 1 g/6 h and Diclofenac 80 mg/24 h.	Drug: Remifentanil; The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.; Other Name: Ultiva; Drug: Desflurane; The patient receives general anesthesia with Desflurane as the routine volatile anesthetic during general anesthesia; Other Name: Desfluran; Drug: Propofol; The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia; Drug: Oxycodone; The control group receives Oxycodone as the routine pain management drug post-operative.
Experimental: Intervention; Induction: Dexmedetomidine 0.2 micrograms/kg/h iv 5 min, Esketamine 0.1mg/kg + Propofol 1.5-2 mg/kg iv, Desflurane MAC (0.6-0.8). Maintained by Desflurane MAC (0.6-0.8) BIS (40-60), Dexmedetomidine 0.2 micrograms/kg/h, Esketamine 0.1-0.3mg/kg/h och 0.1 mg/kg in case of hypertension. At the end of surgery, Lidocaine 1 mg/kg iv (max 4 mg/kg /4 h) Post-operative: Dexmedetomidine (0.1-0.2 micrograms/kg/h up to 4 h post-operative). If the pain is rated NRS ≧3: Transcutaneous Nerve Stimulation (TENS) with high intensive 40-50 mA for 1 minute, if the patient still NRS ≧3, the TENS treatment is repeated one more time. If pain NRS ≧3 after two treatments with TENS: Esketamine 0.1mg/kg iv + Lidocaine 0.5 mg/kg iv (max 4 mg/kg /4 h) If pain NRS still ≧3 within 30 minutes after both TENS and Esketamine/Lidocaine, 2.5 mg Oxycodone iv, with a 10 minutes intervals until NRS < 3. Perioperative and at discharge, PCC will be used for the second half of the intervention.	Drug: Dexmedetomidine; 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: Other Name: Dexdor; Behavioral: Person-centred care (PCC); 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; Drug: Esketamine; 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: Other Name: Ketanest; Drug: Lidocaine; 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.; Other Name: Xylocaine; Device: Transcutaneous Nerve Stimulation (TENS); The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.; Other Name: TENS; Drug: Desflurane; The patient receives general anesthesia with Desflurane as the routine volatile anesthetic during general anesthesia; Other Name: Desfluran; Drug: Propofol; The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia

Outcome Measures

Primary Outcome Measures :

1. Difference in post-operative pain from admission to the post-anesthesia care unit (PACO) to discharge from the PACO unit to the surgical ward. [ 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 ]
   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").

Secondary Outcome Measures :

1. Recovery after surgery [ 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) ]

   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.

2. Average opioid consumption perioperative [ 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 ]
   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.
3. Length of hospital stay [ Time Frame: Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days ]
   Length of indexed hospital stays calculated as the mean length in days from admission to discharge
4. Change in general Self-Efficacy [ Time Frame: 3 months, six months, 12 months, 24 months. ]

   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.

5. Change in Quality of Life [ Time Frame: (3 months, six months, 12 months, 24 months) ]

   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.

6. Exploring patient experience [ Time Frame: 2 weeks after hospital discharge ]

   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.

7. Change in health status [ Time Frame: (3 months, six months, 12 months, 24 months) ]

   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'.

8. Unplanned re-admission [ Time Frame: From time of surgery up until 24 months post-surgery ]
   Investigating re-admission (un-planned) between groups.
9. Mortality [ Time Frame: From time of surgery up until 24 months post-surgery ]
   Investigating mortality rate between groups.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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,

Contacts and Locations

Contacts

Contact: Axel Wolf, RN, PhD; 0046317866034; axel.wolf@gu.se

Locations

Sweden

Lindesberg Hospital; Recruiting

Lindesberg, Region Örebro, Sweden, 711 82

Contact: Henrik Öhström, MD +4619-602 03 56‬ henrik.ohrstrom@regionorebrolan.se

Sahlgrenska University hospital/ Östra hopsital; Recruiting

Gothenburg, VG, Sweden, 41678

Contact: Axel Wolf, RN/MBA/PhD +46709355364 axel.wolf@gu.se

Contact: Sven-Egron Thörn, MD/PhD +46 31-343 49 03 sven-egron.thorn@vgregion.se

Sponsors and Collaborators

Göteborg University

Investigators

• Principal Investigator: Sven-Egron Thörn, MD, PhD; Göteborg University
• Principal Investigator: Axel Wolf, RN, PhD; Göteborg University

More Information

• Responsible Party: Göteborg University
• ClinicalTrials.gov Identifier: NCT03756961
• Other Study ID Numbers: OS-PCC-2017; 2017-003830-97 ( EudraCT Number )
• First Posted: November 28, 2018
• Last Update Posted: September 1, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Göteborg University:

opioids; bariatric surgery; anesthesia; opioid-free; person-centred care; recovery; TENS; pain

Additional relevant MeSH terms:

Obesity; Pain, Postoperative; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Lidocaine; Dexmedetomidine; Remifentanil; Oxycodone; Propofol; Desflurane; Esketamine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Hypnotics and Sedatives; Anesthetics, Intravenous