Postoperative Pain and Analgesic Use After Total Knee Arthroplasty

NCT07457814 | Not Yet Recruiting

• 1 other identifier: 2026-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study evaluates postoperative pain intensity and analgesic consumption in patients undergoing total knee arthroplasty (TKA) under different anesthesia techniques. Patients receive either general anesthesia with peripheral nerve block, spinal anesthesia with peripheral nerve block, spinal anesthesia alone, or general anesthesia with an epidural catheter. Pain scores (NRS), analgesic use, adverse effects, patient satisfaction, and the need for therapeutic interventions are assessed during the first 48 hours after surgery. The study aims to identify differences in postoperative pain control and factors associated with hypotension and other complications.

Conditions

Postoperative Pain After Total Knee Arthroplasty; Postoperative Pain; Analgesic Consumption

Keywords

Total Knee Arthroplasty; Postoperative Pain; Anesthesia Techniques; Analgesic Consumption; Epidural Analgesia; Opioid Use; General Anesthesia; Spinal Anesthesia; Pain Management

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Pain intensity will be assessed using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at predefined postoperative intervals. Both scales range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse pain intensity.

  6 hours, 24 hours, and 48 hours after surgery

Secondary Outcomes (5)

• Analgesic consumption

  First 48 hours after surgery

• Adverse effects

  First 48 hours after surgery

• Patient satisfaction

  48 hours after surgery

• Length of hospital stay

  From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).

• Number of participants requiring therapeutic interventions

  Up to 48 hours after surgery.

Study Arms (4)

General Anesthesia + Peripheral Nerve Block (CA + PNB)

Patients undergoing total knee arthroplasty under general anesthesia combined with a peripheral nerve block. General anesthesia is induced using intravenous and inhalational agents. A peripheral nerve block (most commonly femoral or saphenous) is administered preoperatively to reduce postoperative pain and opioid requirements. This group represents a commonly used multimodal analgesic approach in routine clinical practice.

General Anesthesia + Epidural Catheter (CA + EDA)

Patients undergoing total knee arthroplasty under general anesthesia with an epidural catheter placed for intraoperative and postoperative analgesia. General anesthesia is induced using intravenous and inhalational agents. The epidural catheter allows continuous administration of analgesics and individualized dose adjustment to maintain postoperative pain control. This group represents a commonly used technique for providing extended regional analgesia following TKA.

Spinal Anesthesia + Peripheral Nerve Block (SA + PNB)

Patients undergoing total knee arthroplasty under spinal anesthesia supplemented with a peripheral nerve block. Spinal anesthesia is administered into the subarachnoid space to provide intraoperative analgesia. A peripheral nerve block (femoral or saphenous) is added to enhance postoperative pain control and reduce the need for systemic analgesics. This combination represents a commonly used multimodal analgesic strategy.

Spinal Anesthesia (SA)

Patients receiving spinal anesthesia alone without an additional peripheral nerve block. Spinal anesthesia provides sensory and motor blockade of the lower body during surgery. This group allows evaluation of postoperative pain and analgesic requirements in patients managed with spinal anesthesia as the sole regional technique.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18-100 years undergoing primary total knee arthroplasty at Krajská nemocnice T. Bati, a. s. Patients must have ASA physical status I-III, GCS 15, ability to understand the study procedures, and provide informed consent. Only patients capable of cooperation during pre-anesthetic evaluation and without severe sensory impairment are included.

You may qualify if:

• Age 18-100 years
• Primary total knee arthroplasty (TKA)
• ASA physical status I-III
• Glasgow Coma Scale (GCS) score of 15
• Ability to understand study procedures and provide informed consent
• Ability to cooperate during pre-anesthetic evaluation
• No severe sensory impairment (e.g., blindness, deafness)

You may not qualify if:

• Revision or reoperation of TKA
• ASA score IV or higher
• Refusal to participate or inability to provide informed consent
• GCS ≤ 14
• Limited legal capacity
• Active psychiatric disorder
• Chronic use of strong opioid analgesics
• Neurological disease affecting pain perception or cooperation
• Cognitive impairment or language barrier preventing questionnaire completion
• Use of anesthesia techniques other than GA + PNB or SA + PNB (e.g., epidural anesthesia, local infiltration without PNB)

Sponsors & Collaborators

• Tomas Bata Hospital, Czech Republic: lead

Study Sites (1)

Tomas Bata regional hospital

Zlín, 76001, Czechia

Location

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

Klára Nekvindová, MD, Ph.D.

CONTACT

+420 577 552 111; nekvindova.klara@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Lead, omas Bata Hospital

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)