Rebound Pain After Peripheral Nerve Blocks in Total Knee Arthroplasty

NCT06966011 | Recruiting

• 1 other identifier: 2.02.2025-35892
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Postoperative Pain; Rebound Pain; Peripheral Nerve Block; Pain Management

Outcome Measures

Primary Outcomes (1)

• Incidence of Rebound Pain After Peripheral Nerve Block

  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.

  Within 48 hours after surgery

Secondary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 to 70 years who are scheduled for elective unilateral total knee arthroplasty under spinal anesthesia at a tertiary care hospital. All participants will receive peripheral nerve blocks as part of a standardized multimodal analgesia protocol. Patients must be physically and cognitively able to provide consent and complete a postoperative pain diary. Those with contraindications to regional anesthesia, allergies to local anesthetics, or significant comorbidities (ASA IV and above) will be excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Mahmut Tutar, MD

CONTACT

+905552723704; masatu42@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: May 21, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 25, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)