Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery

Chronic Pain Clinical Trial

Official title:

Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02752477
• Other study ID #: BIO15-253
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2, 2016
• Est. completion date: September 2020

Study information

• Verified date: March 2020
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic pain > 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery

Exclusion Criteria:

• Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device

Related Conditions & MeSH terms

• Anesthesia
• Chronic Pain
• Pain, Postoperative

Intervention

Drug:
• Opioid-free general anesthetic
An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
• Traditional general anesthetic
Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Ben Lim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantified opioid-consumption		48 hours following surgery
Secondary	Visual analogue scale (VAS) pain scores		48 hours following surgery
Secondary	Time of stay in post-anesthetic care unit (PACU)		up to 5 hours following surgery
Secondary	Incidence of adverse events		48 hours following surgery