The Effect of Sedation on Rebound Pain in Knee Arthroplasty

NCT ID: NCT06555458

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-19
• Study Completion Date: 2024-07-25

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.

Conditions

Total Knee Arthroplasty; Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Patient group to be given dexmedetomidine

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Patient group to be given salin

Interventions

Dexmedetomidine

Patient group to be given dexmedetomidine

Intervention Type: DRUG

Saline

Patient group to be given salin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara Bilkent City Hospital

Ankara, ÇANKAYA, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E1-23-4142

Identifier Type: -

Identifier Source: org_study_id