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Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregabalin
Dexmedetomidine
Placebo
Pregabalin and dexmedetomidine
Sponsored by
Wonkwang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring pregabalin, dexmedetomidine, postoperative pain

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • WonwangUH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group PD

Group P

Group D

Group C

Arm Description

combination of pregabalin and dexmedetomidine

pregabalin +placebo

placebo + dexmedetomidine

placebo + placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time to first analgesic request
time to first analgesic request for 24 hours after surgery
visual analog scale (VAS)
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
ketorolac dose for 24 hours after surgery
adverse effects
Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively

Full Information

First Posted
April 8, 2018
Last Updated
April 29, 2018
Sponsor
Wonkwang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03512574
Brief Title
Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pregabalin, dexmedetomidine, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group PD
Arm Type
Experimental
Arm Description
combination of pregabalin and dexmedetomidine
Arm Title
Group P
Arm Type
Active Comparator
Arm Description
pregabalin +placebo
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
placebo + dexmedetomidine
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
placebo + placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery
Intervention Type
Drug
Intervention Name(s)
Pregabalin and dexmedetomidine
Other Intervention Name(s)
study drugs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient controlled analgesics (PCA) volume
Description
Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery
Time Frame
For 24 hours
Secondary Outcome Measure Information:
Title
time to first analgesic request
Description
time to first analgesic request for 24 hours after surgery
Time Frame
for 24 hours
Title
visual analog scale (VAS)
Description
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
Time Frame
for 24 hours
Title
ketorolac dose
Description
ketorolac dose for 24 hours after surgery
Time Frame
for 24 hours
Title
adverse effects
Description
Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively
Time Frame
within the first 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilho Lee, M.D.
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
WonwangUH
City
Iksan
State/Province
Jeonbuk
ZIP/Postal Code
570-711
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

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