Comparison of the effect of intraoperative intravenous lidocaine and dexmedetomidine infusions on post-operative pain and recovery profile in spine surgeries

Comparison of the effect of intraoperative intravenous lidocaine and dexmedetomidine infusions on post-operative pain and recovery profile in spine surgeries – A Randomized non-inferiority trial. - --

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063453

Enrollment

Registered

2024-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: G959- Disease of spinal cord, unspecified

Interventions

Intervention1: injection dexmedetomedine: the above menioned drug when used will be given as intravenous bolus of 0.5 µg/kg (0.125 ml/kg) over a period of 10 minutes and maintanenace of 0.2 µg/kg/ho

Eligibility

Inclusion criteria

Inclusion criteria: a. Inclusion criteria: Patients scheduled for elective spine surgeries (one or two vertebrae levels) under General anesthesia 1. Adult patients aged 18-70years belonging to either sex. 2. American society of Anesthesiologists (ASA) physical status 1-2

Exclusion criteria

Exclusion criteria: b. Exclusion criteria: 1.Allergy to any of the drugs used in the study i.e., lidocaine and dexmedetomidine. 2.Patients having impaired hepatic or renal function or ischemic heart disease. 3.Patients with conduction blocks or arrhythmias. 4.Patients with psychiatric illness and seizure disorder. 5.Patients who are on opioid supplements for pain management within two weeks of surgery

Design outcomes

Primary

Measure	Time frame
Comparison of 24 hours post-operative morphine consumption between the groups using patient-controlled analgesiaTimepoint: Postoperatively all patients will have access to PCA pump for 24 hours to receive a bolus of 1 mg morphine with a lock-out interval of 15 minutes without background infusion.	—

Secondary

Measure	Time frame
Comparison of 1 Intraoperative fentanyl requirement between the groups 2 Hemodynamic parameters MAP & HR between groups 3 Time of emergence between groups 4 Pain at postoperative periods of 1 6 12 24 48 hours using NRS pain scale between groups at rest & during movement 5 Opioid related side effects postoperative nausea & vomiting pruritus sedation using Richmond Agitation Sedation scale 6 Recovery characteristics between groups using Quality of Recovery 15 QoR15 score at the end of 48 hours in the postoperative period Timepoint: 1 6 12 24 48 hours pain score in postoperative period	—

Measure

Time frame

Comparison of 1 Intraoperative fentanyl requirement between the groups 2 Hemodynamic parameters MAP & HR between groups 3 Time of emergence between groups 4 Pain at postoperative periods of 1 6 12 24 48 hours using NRS pain scale between groups at rest & during movement 5 Opioid related side effects postoperative nausea & vomiting pruritus sedation using Richmond Agitation Sedation scale 6 Recovery characteristics between groups using Quality of Recovery 15 QoR15 score at the end of 48 hours in the postoperative period Timepoint: 1 6 12 24 48 hours pain score in postoperative period

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Countries

India

Contacts

Public ContactDr Gnanasekaran S

Jawaharlal Institute of Postgraduate Medical Education and Research,PUDUCHERRY

gnansdr@gmail.com9487188275

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026