Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

NCT ID: NCT03512574

Last Updated: 2018-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group PD

combination of pregabalin and dexmedetomidine

Group Type EXPERIMENTAL

Pregabalin and dexmedetomidine

Intervention Type DRUG

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.

Group P

pregabalin +placebo

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

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

Group D

placebo + dexmedetomidine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Group C

placebo + placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Placebo

One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery

Intervention Type OTHER

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.

Intervention Type DRUG

Other Intervention Names

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Lyrica precedex study drugs

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wonkwang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheol Lee

Professor,M.D.,Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilho Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wonkwang University Hospital

Locations

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WonwangUH

Iksan, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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WonkwangUH5

Identifier Type: -

Identifier Source: org_study_id

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