Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

NCT03512574 | Completed Phase 4 DMC

• 1 other identifier: WonkwangUH5
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Keywords

pregabalin, dexmedetomidine, postoperative pain

Outcome Measures

Primary Outcomes (1)

• Patient controlled analgesics (PCA) volume

  Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery

  For 24 hours

Secondary Outcomes (4)

• time to first analgesic request

  for 24 hours

• visual analog scale (VAS)

  for 24 hours

• ketorolac dose

  for 24 hours

• adverse effects

  within the first 24 hours postoperatively

Study Arms (4)

Group PD

EXPERIMENTAL

combination of pregabalin and dexmedetomidine

Drug: Pregabalin and dexmedetomidine

Group P

ACTIVE COMPARATOR

pregabalin +placebo

Drug: Pregabalin

Group D

ACTIVE COMPARATOR

placebo + dexmedetomidine

Drug: Dexmedetomidine

Group C

PLACEBO COMPARATOR

placebo + placebo

Other: Placebo

Interventions

Pregabalin 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

Also known as: Lyrica

Group P

Dexmedetomidine 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

Also known as: precedex

Group D

Placebo OTHER

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

Group C

Pregabalin and dexmedetomidine 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.

Also known as: study drugs

Group PD

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

WonwangUH

Iksan, Jeollabuk-do, 570-711, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gilho Lee, M.D.

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,M.D.,Ph.D

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: May 1, 2018
• Study Start: January 2, 2018
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)