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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Opioid-Sparing Protocol

    Drug

    The opioid-sparing anesthesia protocol consists of continuous intravenous infusion of ketamine (5 μg/kg/min) and dexmedetomidine (0.6 μg/kg/h) during general anesthesia. If needed during surgery, rescue analgesia with dexmedetomidine (0.4 μg/kg, i.v.) or ketamine (5 mg, i.v.) may be administered as clinically indicated.

  • Routine anesthesia protocol

    Drug

    Routine anesthesia consisting of standard general anesthetic management per institutional practice, which include opioid-based analgesia as clinically indicated, which is fentanyl 100 μg during induction, and if needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group 1:Opioid-Sparing AnesthesiaExperimental treatment 1 intervention
Group B: Group 2:Routine AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid consumption

Total morphine equivalent consumption during the first 24 hours after surgery

Time frame
From end of surgery to 24 hours after surgery

Secondary outcomes

1

Pain Scores (NRS)

Pain intensity will be assessed after recovery and 1, 6, 24, 48, 72 hours after surgery using the Numeric Rating Scale (NRS) daily, including NRS at rest, NRS on movement.

Time frame
From end of surgery to postoperative 72 hours
2

Time to First Rescue Analgesia

The exact time (in hours and minutes) from the end of surgery to the administration of the first rescue analgesic will be recorded.

Time frame
From end of surgery to the administration of the first rescue analgesic
3

Total Analgesic Consumption

The cumulative amount of all pain medications (opioid and non-opioid, oral and intravenous) administered within 3 days postoperatively, including total morphine equivalent consumption during 48 hours and 72 hours after surgery.

Time frame
From end of surgery to postoperative 72 hours
4

Time to first postoperative flatus

The exact time (in hours and minutes) from the end of surgery to the first postoperative flatus will be recorded.

Time frame
Up to 72 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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