Not Yet RecruitingPhase 2Other

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

Sponsored by Massachusetts General Hospital

NCT ID
NCT07588802
Target Enrollment
120 participants
Start Date
2026-07
Est. Completion
2027-05

About This Study

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.

Conditions Studied

Opoid ManagmentPain Management

Interventions

  • Opioid-Sparing Protocol
  • Routine anesthesia protocol

Eligibility

Age:65 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Aged ≥ 65 years
* Undergoing multilevel level (≥2 levels) spine surgery under general anesthesia
* Able to provide written informed consent

Exclusion Criteria:

* 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
* Refuse to participate

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source