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Clinical Trials/NCT06966011
NCT06966011RecruitingNot Applicable

Pain Management After Total Knee Arthroplasty: Incidence and Outcomes of Rebound Pain

Konya City Hospital1 site in 1 country300 target enrollmentStarted: May 21, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
Incidence of Rebound Pain After Peripheral Nerve Block

Study Overview

Brief Summary

This prospective observational study aims to determine the incidence and clinical impact of rebound pain after peripheral nerve blocks in patients undergoing total knee arthroplasty. Rebound pain is defined as a sudden, severe pain (NRS ≥7) emerging after block resolution. Primary outcome is the incidence of rebound pain; secondary outcomes include pain severity, rescue analgesia use, nausea, vomiting, sleep quality, and patient satisfaction.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age between 18 and 70 years
  • •ASA physical status I to III
  • •Scheduled for elective unilateral total knee arthroplasty under spinal anesthesia
  • •Peripheral nerve block (PNB) planned as part of multimodal analgesia
  • •Ability to understand and provide written informed consent
  • •Willingness and ability to complete the postoperative pain diary

Exclusion Criteria

  • •Known allergy or hypersensitivity to local anesthetics
  • •Contraindication to regional anesthesia
  • •ASA physical status IV or higher
  • •Neurological or psychiatric disorders interfering with study participation or pain reporting
  • •Use of anticoagulants or presence of coagulopathy
  • •Use of medications that may alter pain perception or rebound pain response
  • •Local infection at the block site
  • •Emergency surgeries
  • •Inability or unwillingness to complete the postoperative pain diary or follow-up

Outcomes

Primary Outcomes

Incidence of Rebound Pain After Peripheral Nerve Block

Time Frame: Within 48 hours after surgery

Rebound pain is defined as a sudden, severe increase in pain occurring after the resolution of peripheral nerve block, typically within 12-24 hours postoperatively. Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). A score of NRS ≥7 will be considered as severe pain. Patients will record pain scores in a pain diary, and incidence will be calculated as the proportion of patients meeting the rebound pain criteria.

Secondary Outcomes

  • Sleep Quality(From 1 day before surgery to postoperative day 7)
  • Patient Satisfaction with Pain Management(Postoperative day 7 (via telephone follow-up))
  • Total Rescue Analgesic Consumption(Within 48 hours after surgery)
  • Time to First Rescue Analgesia(Within 48 hours after surgery)

Investigators

Sponsor
Konya City Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Konya City Hospital

Study Sites (1)

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