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NCT Number: NCT03512574

Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

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

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Key information

Conditions

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

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

WonwangUH

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Lyrica

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

Other names: precedex

Placebo

Other

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

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.

Other names: study drugs

Primary outcomes

  1. Patient controlled analgesics (PCA) volume

    Time frame: For 24 hours

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 1, 2018
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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