---
title: Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain
nct_id: NCT03512574
overall_status: COMPLETED
phase: PHASE4
sponsor: Wonkwang University Hospital
study_type: INTERVENTIONAL
primary_condition: Pain, Postoperative
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03512574.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03512574"
ct_last_update_post_date: 2018-05-01
last_seen_at: "2026-05-12T06:05:10.141Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03512574](https://clinicaltrials.gov/study/NCT03512574)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** Wonkwang University Hospital
- **Conditions:** Pain, Postoperative
- **Start Date:** 2018-01-02
- **Completion Date:** 2018-03-30
- **CT.gov Last Update:** 2018-05-01

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Group PD** (EXPERIMENTAL) — combination of pregabalin and dexmedetomidine
- **Group P** (ACTIVE_COMPARATOR) — pregabalin +placebo
- **Group D** (ACTIVE_COMPARATOR) — placebo + dexmedetomidine
- **Group C** (PLACEBO_COMPARATOR) — placebo + placebo

## Interventions

- **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
- **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
- **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.

## Primary Outcomes

- **Patient controlled analgesics (PCA) volume** _(time frame: For 24 hours)_ — Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery

## Secondary Outcomes

- **time to first analgesic request** _(time frame: for 24 hours)_
- **visual analog scale (VAS)** _(time frame: for 24 hours)_
- **ketorolac dose** _(time frame: for 24 hours)_
- **adverse effects** _(time frame: within the first 24 hours postoperatively)_

## Locations (1)

- WonwangUH, Iksan, Jeollabuk-do, South Korea

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.wonwanguh|iksan|jeollabuk-do|south korea` — added _(2026-05-12)_

---

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