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OpenTrials
Completed

NCT Number: NCT06555458

The Effect of Sedation on Rebound Pain in Knee Arthroplasty

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.

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Key information

Conditions

Total Knee Arthroplasty Sedation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

About this study

Randomization will take place before the patient enters the operating room. After spinal anesthesia is applied, 0.4 mcg/kg sedadomide loading will be done for 10 minutes in the sedation group, and then 0.4 mcg/kg/h sedadomide infusion will continue until the end of the surgery. Patients selected for the control group will be given the same amounts of saline. At the end of the surgical procedure, saline and sedadomide infusions will be stopped. All patients will undergo an adductor canal block under USG guidance in the recovery room. 50 mg of buvacin will be given to the block area. Patients will be fitted with a patient control analgesia device, which only provides bolus application and provides 20 mg of madol in each bolus. Postoperatively, sudden onset severe withdrawal pain outside the normal course of pain starting within 48 hours will be followed and Vas-bromage monitoring will be done at 0, 1, 2, 4, 8, 12, 24, 36, 48 hours.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine

Drug

Patient group to be given dexmedetomidine

Saline

Drug

Patient group to be given salin

Primary outcomes

  1. Rebound pain VAS scores and incidence of rebound pain

    Time frame: 48 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effect of Sedation on Rebound Pain in Knee Arthrplasty Performed Under Spinal Anesthesia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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