Reducing Postoperative Side Effect of Pregabalin

• Sponsor: The First Hospital of Jilin University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04599894
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.3
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

To see the effect of application of 37.5mg pregabalin in TJA before the day of surgery on reducing postoperative side effect of this medicine

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip	Drug: 37.5mg Pregabalin + 75mg Pregabalin; Drug: 75mg Pregabalin	Phase 4

Detailed Description

A prospective randomized controlled study was designed to be carried out by enrolling 40 patients underwent surgery for joint replacement from October 2020 to February 2021. The experimental group: Oral administration of Pregabalin (37.5mg) at 8 am and 18 pm 1 d before operation; oral administration of Pregabalin (75mg) 2h before operation; and oral administration of Pregabalin (75mg) at 18 pm from the first day after operation to discharge (n=20). The control group: Oral administration of Pregabalin (75mg) 2h before operation; and oral administration of Pregabalin (75mg) at 18 pm from the first day after operation to discharge (n=20).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Application of Low Dose of Pregabalin in TJA Before the Day of Surgery on Reducing Postoperative Side Effect of This Medicine
• Anticipated Study Start Date: Oct 21, 2020
• Anticipated Primary Completion Date: Jan 31, 2021
• Anticipated Study Completion Date: Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: control group Oral administration of Pregabalin (75mg) 2h before operation; and oral administration of Pregabalin (75mg) at 18 pm from the first day after operation to discharge.	Drug: 75mg Pregabalin; 75mg pregabalin postoperatively
Experimental: study group Oral administration of Pregabalin (37.5mg) at 8 am and 18 pm 1 d before operation; oral administration of Pregabalin (75mg) 2h before operation; and oral administration of Pregabalin (75mg) at 18 pm from the first day after operation to discharge.	Drug: 37.5mg Pregabalin + 75mg Pregabalin; 37.5mg pregabalin preoperatively + 75mg pregabalin postoperatively

Outcome Measures

Primary Outcome Measures

1. sedation [postoperative day 1]

   sedation evaluated by Richmond Agitation-Sedation Scale, the minimum and maximum values are -5 to 0, higher scores mean a better outcome.

2. sedation [postoperative day 2]

   sedation evaluated by Richmond Agitation-Sedation Scale, the minimum and maximum values are -5 to 0, higher scores mean a better outcome.

3. sedation [postoperative day 3]

   sedation evaluated by Richmond Agitation-Sedation Scale, the minimum and maximum values are -5 to 0, higher scores mean a better outcome.

4. dizziness [postoperative day 1]

   number of cases that complained dizziness

5. dizziness [postoperative day 2]

   number of cases that complained dizziness

6. dizziness [postoperative day 3]

   number of cases that complained dizziness

Secondary Outcome Measures

1. evaluation of pain [postoperative day 1]

   Visual Analog Score for pain, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.

2. evaluation of pain [postoperative day 2]

   Visual Analog Score for pain, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.

3. evaluation of pain [postoperative day 3]

   Visual Analog Score for pain, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.

4. range of motion [postoperative day 1]

   degree of knee extension to flexion

5. range of motion [postoperative day 2]

   degree of knee extension to flexion

6. range of motion [postoperative day 3]

   degree of knee extension to flexion

7. functional outcome [postoperative 6 weeks]

   functional outcome evaluated by knee society score, the minimum and maximum values are 0 to 100, higher scores mean a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• clinical diagnosis of knee osteoarthritis；

• avascular necrosis of femoral head；

• dysplasia of the hip joint.

Exclusion Criteria:

• history of neuropathic pain or other chronic pain;

• unable to cooperate, allergic to drugs used in this study；

• intolerant of non-steroidal anti-inflammatory drugs, or had long-term opioid use;

• ASA grade IV or above;

• medical history of vertigo and other diseases that might induce dizziness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Hospital of Jilin University	Changchun		China

Sponsors and Collaborators

• The First Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT04599894
• Other Study ID Numbers: QiXin1
• First Posted: Oct 23, 2020
• Last Update Posted: Oct 23, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by The First Hospital of Jilin University: pregabalin; total joint arthroplasty; side effect
• Additional relevant MeSH terms: Pain, Postoperative; Pregabalin

Study Results

No Results Posted as of Oct 23, 2020