The Effect of Sedation on Rebound Pain in Knee Arthroplasty

NCT06555458 | Completed

• 1 other identifier: E1-23-4142
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores.

Conditions

Total Knee Arthroplasty; Sedation

Outcome Measures

Primary Outcomes (1)

• Rebound pain VAS scores and incidence of rebound pain

  Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.

  48 hours after surgery

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Patients will receive the standardized pre-op meds and spinal anesthetic. Once the patient's spinal is performed, patient will receive the following: Start with bolus of 0.4 microgram/kg over 10 minutes, and then infusion of 0.4 microgram/kg/hr infusion will be stopped after the last staple or suture is performed on the incision. Interventions: Drug: Dexmedetomidine

Drug: Dexmedetomidine

Saline

PLACEBO COMPARATOR

Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo. Interventions: Drug: Normal Saline

Drug: Saline

Interventions

Dexmedetomidine DRUG

Patient group to be given dexmedetomidine

Dexmedetomidine

Saline DRUG

Patient group to be given salin

Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.

You may not qualify if:

• Situations in which spinal anesthesia is contraindicated
• Advanced organ failure states(cardiac,hepatic,respiratuar or renal)
• Pregnancy
• BMI \> 40 kg/m\^2
• Do not want to participate in the study
• Younger than 18 or older than 85
• Have bilateral total knee arthroplasty or resurgery
• Develop an unexpected intraoperative surgical complication

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: November 19, 2023
• Primary Completion: March 30, 2024
• Study Completion: July 25, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

TU (1)