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Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

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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

Tracking Information
First Submitted Date  ICMJE April 8, 2018
First Posted Date  ICMJE May 1, 2018
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE January 2, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2018)
Patient controlled analgesics (PCA) volume [ Time Frame: For 24 hours ]
Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2018)
  • time to first analgesic request [ Time Frame: for 24 hours ]
    time to first analgesic request for 24 hours after surgery
  • 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
  • ketorolac dose [ Time Frame: for 24 hours ]
    ketorolac dose for 24 hours after surgery
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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
  • 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
  • Other: Placebo
    One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery
  • 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
Study Arms  ICMJE
  • Experimental: Group PD
    combination of pregabalin and dexmedetomidine
    Intervention: Drug: Pregabalin and dexmedetomidine
  • Active Comparator: Group P
    pregabalin +placebo
    Intervention: Drug: Pregabalin
  • Active Comparator: Group D
    placebo + dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: Group C
    placebo + placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2018)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03512574
Other Study ID Numbers  ICMJE WonkwangUH5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cheol Lee, Wonkwang University Hospital
Study Sponsor  ICMJE Wonkwang University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gilho Lee, M.D. Wonkwang University Hospital
PRS Account Wonkwang University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP