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Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03512574
Enrollment
150
Registered
2018-05-01
Start date
2018-01-02
Completion date
2018-03-30
Last updated
2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

pregabalin, dexmedetomidine, postoperative pain

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.

Interventions

DRUGPregabalin

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

DRUGDexmedetomidine

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

OTHERPlacebo

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

DRUGPregabalin 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.

Sponsors

Wonkwang University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient controlled analgesics (PCA) volumeFor 24 hoursPatient controlled analgesics (PCA) volume consumed for 24 hours after surgery

Secondary

MeasureTime frameDescription
time to first analgesic requestfor 24 hourstime to first analgesic request for 24 hours after surgery
visual analog scale (VAS)for 24 hoursThe 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 dosefor 24 hoursketorolac dose for 24 hours after surgery
adverse effectswithin the first 24 hours postoperativelyPerioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026