Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Pregabalin and dexmedetomidine; Other: Placebo; Drug: Dexmedetomidine; Drug: Pregabalin

• Registration Number: NCT03512574
• Lead Sponsor: Wonkwang University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2018-04
• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-29
• Last Update Submitted: 2018-04-29
• Study First Posted: 2018-05-01
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group PD	Pregabalin and dexmedetomidine	combination of pregabalin and dexmedetomidine
Group C	Placebo	placebo + placebo
Group D	Dexmedetomidine	placebo + dexmedetomidine
Group P	Pregabalin	pregabalin +placebo

Primary Outcome Measures

Name	Time	Method
Patient controlled analgesics (PCA) volume	For 24 hours	Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
time to first analgesic request	for 24 hours	time to first analgesic request for 24 hours after surgery
visual analog scale (VAS)	for 24 hours	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
ketorolac dose	for 24 hours	ketorolac dose for 24 hours after surgery
adverse effects	within the first 24 hours postoperatively	Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively

Trial Locations

Locations (1)

WonwangUH; 🇰🇷 Iksan, Jeonbuk, Korea, Republic of