The Effect of Sedation on Rebound Pain in Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Sedation; Total Knee Arthroplasty
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; 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; Patient group to be given dexmedetomidine
Placebo Comparator: Saline; 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; Patient group to be given salin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: E1-23-4142

Drug and device information, study documents

• 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