Opioid-free Anesthesia and Acute Postoperative Pain

Acute Postoperative Pain in Opioid-free Anesthesia After Urological Procedures

Control of intraoperative and postoperative pain with the use of opioids constitutes normal practice. Opioid free anesthesia (OFA) is a relatively recent anesthesiology practice according to which opioids are not administered during surgery and are avoided postoperatively. Opioid free anesthesia seems to provide better quality of postoperative analgesia while protecting the patient from the side effects of opioids such as respiratory depression, postoperative nausea and vomiting (PONV), opioid induced hyperalgesia and postoperative cognitive dysfunction. The aim of this study is to investigate the possible difference in the intensity of postoperative pain (based on the numeric rating scale 0-10) and the presence of PONV in patients undergoing transurethral urologic surgery under general anesthesia, when patients receive randomly either opioid free anesthesia (OFA) or opioid based anesthesia (OBA).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Anesthesia; Cognitive Impairment, Variable
• Intervention / Treatment: Device: OFA; Drug: OBA

Detailed Description

This study aimed to study postoperative pain after opioid free anesthesia or opioid based anesthesia after urologica; procedures. The two study groups opioid free (OFA) and opioid based (OBA) were as follows:

OFA: Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.

OBA: Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).

Both groups receive ranitidine 50mg, dexamethasone 4 mg and paracetamol 1g iv 15 min before the end of surgery. Postoperative analgesia for both groups consists of paracetamol 3g/24h iv, rescue analgesia with tramadol 1mg/kg iv max x3, rescue for PONV ondacetron 4 mg iv.

The outcomes assessed were:

Primary outcome:

1. Intensity of acute postoperative pain (NRS 0-10), time frame up to 24h postoperatively
2. Nausea and vomiting

Secondary outcome:

1. Change in minimental state evaluation test, time frame pre-op, 1h post-op, at discharge
2. Severe postoperative adverse effect related to anesthesia (postoperative hypoxemia, ileus, postoperative cognitive dysfunction)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CHRΥSANTHI BATISTAKI, MD, PHD; Phone Number: 00302105832371; Email: chrysabatistaki@yahoo.gr
• Study Contact Backup: Name: Paraskevi Matsota, MD, PHD; Phone Number: 00302105832371; Email: matsota@yahoo.gr

Study Locations

• Greece
  • Athens, Greece, 12462
    • Recruiting
    • 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients aged>18 years old
• ASA I-III
• Patients scheduled for elective transurethral urologic surgery with general anesthesia

Exclusion Criteria:

• • Patient refusal

  • Use of opioids pre-op
  • Inability to read or write
  • Known psychiatric disease under medication
  • Dementia
  • Severe liver and renal disease
  • Known allergy to drugs used
  • Known arrhythmia (2nd-3rd AV block, acute unstable angina, acute myocardial infarction in the past 6 weeks or severe cardiac problem-condition)
  • Heart rate<45 bpm
  • Pre-op minimental test<23
  • Major surgery complications (hemorrhage with need for transfusion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opioid-free anesthesia; Opioid free anesthesia protocol for urological procedurs	Device: OFA; Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.
Active Comparator: Opioid-based anesthesia; Opioid based anesthesia protocol for urological procedures	Drug: OBA; Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Intensity of acute postoperative pain (measured by numeric rating scale NRS 0-10), time frame up to 24h postoperatively	baseline and 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative cognitive dysfunction	Change in minimental state evaluation test up to 24 hours postoperatively	baseline and 24 hours

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 10, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 7, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: PAIN; ANESTHESIA; OPIOIDS; COGNITIVE
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: OFA 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No