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The Effect of Sedation on Rebound Pain in Knee Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06555458
Enrollment
84
Registered
2024-08-15
Start date
2023-11-19
Completion date
2024-07-25
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation, Total Knee Arthroplasty

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.

Detailed description

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.

Interventions

DRUGDexmedetomidine

Patient group to be given dexmedetomidine

DRUGSaline

Patient group to be given salin

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rebound pain VAS scores and incidence of rebound pain48 hours after surgeryRebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026