Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

The Effect of the Combination of Pregabalin and Dexmedetomidine on the Management of Postoperative Pain in Patients Undergoing Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) Under Spinal Anesthesia

Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Pregabalin and dexmedetomidine; Drug: Pregabalin; Drug: Dexmedetomidine; Other: Placebo

Detailed Description

One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33, pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31, dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. Clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (VAS), ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonbuk
    • Iksan, Jeonbuk, Korea, Republic of, 570-711
      • WonwangUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II
• Aged 18-75 years

One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia

Exclusion Criteria:

• Pregnant
• Allergic and/or contraindicated to the study drugs
• American Society of Anesthesiologists (ASA) score III and above
• Having drug
• Alcohol addiction
• Renal failure
• Diabetes mellitus
• Epilepsy
• currently using opioids for chronic pain and/or any of the drugs studied.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group PD; combination of pregabalin and dexmedetomidine	Drug: Pregabalin and dexmedetomidine; One hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery.; Other Names: study drugs
Active Comparator: Group P; pregabalin +placebo	Drug: Pregabalin; One hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery; Other Names: Lyrica
Active Comparator: Group D; placebo + dexmedetomidine	Drug: Dexmedetomidine; One hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery; Other Names: precedex
Placebo Comparator: Group C; placebo + placebo	Other: Placebo; One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient controlled analgesics (PCA) volume	Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery	For 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first analgesic request	time to first analgesic request for 24 hours after surgery	for 24 hours
visual analog scale (VAS)	The VAS consisted of a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain. Patients were asked to mark the position on the line corresponding to their perception of pain. The VAS scores for pain at rest and on movement were measured at intervals of 24, and 48 hours after surgery	for 24 hours
ketorolac dose	ketorolac dose for 24 hours after surgery	for 24 hours
adverse effects	Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively	within the first 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Wonkwang University Hospital
• Investigators: Principal Investigator: Gilho Lee, M.D., Wonkwang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: April 8, 2018
• First Submitted That Met QC Criteria: April 29, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: pregabalin, dexmedetomidine, postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Dexmedetomidine; Pregabalin
• Other Study ID Numbers: WonkwangUH5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No