Effect of Rebound Pain on Chronic Postsurgical Pain After Total Knee Arthroplasty

NCT07511985 | Not Yet Recruiting

• 1 other identifier: KONYAEH-RA-TDP-2025-01
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational study aims to evaluate whether rebound pain after peripheral nerve block is associated with the development of chronic postsurgical pain following elective total knee arthroplasty. Adult patients undergoing unilateral total knee arthroplasty under spinal anesthesia and receiving a peripheral nerve block as part of routine multimodal analgesia will be included. No additional intervention, drug administration, or biological sampling will be performed beyond standard clinical care. Rebound pain will be assessed during the early postoperative period using pain diaries, numeric rating scale pain scores, and analgesic consumption records. Chronic postsurgical pain and related outcomes will be evaluated at postoperative 3 and 6 months using validated instruments assessing pain severity, neuropathic pain features, psychological status, functional outcomes, and health-related quality of life. The primary outcome is the presence of chronic postsurgical pain at 3 months after surgery. Secondary outcomes include chronic pain at 6 months, pain intensity, neuropathic pain characteristics, opioid consumption, rescue analgesic requirements, sleep disturbance, and quality-of-life measures. The study also aims to explore demographic and clinical factors associated with rebound pain and chronic postsurgical pain.

Conditions

Chronic Pain; Arthroplasty, Replacement, Knee; Acute Pain, Postoperative

Keywords

rebound pain; chronic postsurgical pain; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Presence of Chronic Postsurgical Pain at 3 Months

  Chronic postsurgical pain will be defined as pain developing or persisting after total knee arthroplasty that is not explained by another cause. Participants with pain and at least one Brief Pain Inventory-Short Form interference item score of 3 or higher at postoperative month 3 will be considered positive for chronic postsurgical pain.

  3 months after surgery

Secondary Outcomes (2)

• Presence of Chronic Postsurgical Pain at 6 Months assessed by Brief Pain Inventory-Short Form (BPI-SF) interference score

  6 months after surgery

• Pain Intensity in the Early Postoperative Period

  0 to 72 hours after surgery

Study Arms (2)

Rebound Pain

Participants with a transition from well-controlled pain (Numeric Rating Scale \[NRS\] \<=3) to severe pain (NRS \>=7) within 0 to 48 hours after peripheral nerve block resolution.

No Rebound Pain

Participants without a transition from well-controlled pain (Numeric Rating Scale \[NRS\] \<=3) to severe pain (NRS \>=7) within 0 to 48 hours after peripheral nerve block resolution.

Eligibility Criteria

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

Study Population

Adult patients undergoing unilateral elective total knee arthroplasty at Konya City Hospital under spinal anesthesia and receiving a peripheral nerve block as part of routine multimodal analgesia.

You may qualify if:

• Age 18 years or older
• ASA physical status I to III
• Scheduled for unilateral elective total knee arthroplasty
• Planned to undergo spinal anesthesia
• Planned to receive a peripheral nerve block as part of routine multimodal analgesia
• Able to provide informed consent and complete study assessments

You may not qualify if:

• Chronic opioid use (60 mg oral morphine equivalent per day or more, or use for 3 months or longer)
• Significant neuropathy or radiculopathy
• Bilateral or two-stage total knee arthroplasty during the same hospitalization
• Contralateral total knee arthroplasty within the previous 6 months
• Severe cognitive impairment or major psychiatric disorder
• Chronic analgesic dependence

Sponsors & Collaborators

• Konya City Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mahmut Tutar, MD

  KONYA CITY HOSPİTAL

  PRINCIPAL INVESTIGATOR

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: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share