Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Elderly Patients Undergoing Spine Surgery

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorMassachusetts General Hospital

About this trial

The goal of this clinical trial is to learn if an anesthesia management strategy called opioid-sparing anesthesia could help reduce postoperative opioid consumption, pain intensity and enhance recovery in elderly patients undergoing spine surgery. The main questions it aims to answer are:

Does opioid-sparing anesthesia reduce postoperative opioid consumption?

Dose opioid-sparing anesthesia improve postoperative pain and enhance recovery?

Researchers will compare opioid-sparing anesthesia to routine anesthesia which is used most common in clinical practice to see if opioid-sparing anesthesia lead to fewer postoperative opioid consumption and better pain and recovery outcomes.

Participants will randomly assigned to one of two groups. One group will receive opioid-sparing anesthesia management , while the other group will receive routine anesthesia management during general anesthesia.

Participants will provide two rectal swab samples for analysis, complete five questionnaires once preoperatively, and then complete five questionnaires daily for three days postoperatively.

Eligibility criteria

Qualifiers

Aged ≥ 65 years

Undergoing multilevel level (≥2 levels) spine surgery under general anesthesia

Able to provide written informed consent

Disqualifiers

Diagnosed with severe cognitive impairment or psychiatric disorders that impair participation or communication

Pregnant or breastfeeding

Patients with contraindications to any of the medications in the study protocol (unstable angina, recent myocardial infarction, cerebral or aortic aneurysms, increased intracranial pressure, increased intraocular pressure, psychosis or schizophrenia, pheochromocytoma, epilepsy, second- or third-degree atrioventricular block, bradycardia (heart rate < 50bpm), liver failure, hypotension (systolic BP <80 mmHg))

Drug or alcohol abuse

Trial design

Treatments tested in this trial

  • Opioid-Sparing Protocol
  • Routine anesthesia protocol

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators