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OpenTrials
Completed

NCT Number: NCT06966011

Rebound Pain After Peripheral Nerve Blocks in Total Knee Arthroplasty

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Sleep Quality

    Time frame: From 1 day before surgery to postoperative day 7

    Sleep quality will be assessed using a 6-item sleep questionnaire (scored 1-6, where 1 = best and 6 = worst sleep quality), covering the night before surgery and the first 7 nights postoperatively.

  2. Patient Satisfaction with Pain Management

    Time frame: Postoperative day 7 (via telephone follow-up)

    Patients will rate their satisfaction with postoperative pain control on a 5-point Likert scale (1 = not at all satisfied, 5 = completely satisfied).

  3. Total Rescue Analgesic Consumption

    Time frame: Within 48 hours after surgery

    The total dose of rescue opioid analgesics administered within the first 48 hours postoperatively will be recorded in milligrams.

  4. Time to First Rescue Analgesia

    Time frame: Within 48 hours after surgery

    Time elapsed from the end of surgery to the first administration of rescue analgesia will be recorded.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
Apr 3, 2026

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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