Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03512574
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Cheol Lee, 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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Pregabalin Drug: Dexmedetomidine Other: Placebo Drug: Pregabalin and dexmedetomidine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Patient controlled analgesics (PCA) volume [ Time Frame: For 24 hours ]
    Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery


Secondary Outcome Measures :
  1. time to first analgesic request [ Time Frame: for 24 hours ]
    time to first analgesic request for 24 hours after surgery

  2. visual analog scale (VAS) [ Time Frame: 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

  3. ketorolac dose [ Time Frame: for 24 hours ]
    ketorolac dose for 24 hours after surgery

  4. adverse effects [ Time Frame: within the first 24 hours postoperatively ]
    Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512574


Locations
Layout table for location information
Korea, Republic of
WonwangUH
Iksan, Jeonbuk, Korea, Republic of, 570-711
Sponsors and Collaborators
Wonkwang University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Gilho Lee, M.D. Wonkwang University Hospital

Layout table for additonal information
Responsible Party: Cheol Lee, Professor,M.D.,Ph.D, Wonkwang University Hospital
ClinicalTrials.gov Identifier: NCT03512574     History of Changes
Other Study ID Numbers: WonkwangUH5
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cheol Lee, Wonkwang University Hospital:
pregabalin, dexmedetomidine, postoperative pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs