Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512574
• Other study ID #: WonkwangUH5
• Status: Completed
• Phase: Phase 4
• Start date: January 2, 2018
• Est. completion date: March 30, 2018

Study information

• Verified date: April 2018
• Source: Wonkwang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Drug:
• Pregabalin 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.

Locations

Country	Name	City	State
Korea, Republic of	WonwangUH	Iksan	Jeonbuk

Sponsors (1)

Lead Sponsor	Collaborator
Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient controlled analgesics (PCA) volume	Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery	For 24 hours
Secondary	time to first analgesic request	time to first analgesic request for 24 hours after surgery	for 24 hours
Secondary	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	for 24 hours
Secondary	ketorolac dose	ketorolac dose for 24 hours after surgery	for 24 hours
Secondary	adverse effects	Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively	within the first 24 hours postoperatively