Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

Wonkwang University Hospital

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Pregabalin and dexmedetomidine; Other: Placebo; Drug: Dexmedetomidine; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT03512574

WonkwangUH5

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 4 patient groups, including a placebo group

Group PD

Experimental group

Description:

combination of pregabalin and dexmedetomidine

Treatment:

Drug: Pregabalin and dexmedetomidine

Group P

Active Comparator group

Description:

pregabalin +placebo

Treatment:

Drug: Pregabalin

Group D

Active Comparator group

Description:

placebo + dexmedetomidine

Treatment:

Drug: Dexmedetomidine

Group C

Placebo Comparator group

Description:

placebo + placebo

Treatment:

Other: Placebo