Regional Anesthesia in TKA: Impact on Postoperative Joint Motion and Patient Satisfaction

NCT ID: NCT07124494

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-02-19

Brief Summary

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This is a single-center, prospective, randomized controlled trial aiming to evaluate the effects of different regional anesthesia/analgesia techniques on postoperative knee range of motion (ROM) and patient satisfaction following total knee arthroplasty (TKA). Ninety patients undergoing elective TKA under spinal anesthesia will be randomly assigned to one of three groups: 1) spinal anesthesia with epidural catheter, 2) spinal anesthesia followed by adductor canal catheterization, and 3) spinal anesthesia with multimodal intravenous analgesia. The primary outcome is postoperative knee joint ROM measured on postoperative days 1, 2, and 3. Secondary outcomes include patient satisfaction, Oxford Knee Score, postoperative opioid consumption, and VAS scores. The study is conducted at Konya City Hospital and will be completed over a 6-month period.

Detailed Description

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Conditions

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Total Knee Arthroplasty Postoperative Pain Regional Anesthesia Knee Range of Motion Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Combined Spinal-Epidural Anesthesia

Postoperative analgesia will be provided via epidural catheter with programmed infusion of bupivacaine .

Group Type ACTIVE_COMPARATOR

Regional anethesia

Intervention Type PROCEDURE

This single-center, prospective, randomized controlled trial aims to compare the effects of three different postoperative analgesia techniques following spinal anesthesia in patients undergoing total knee arthroplasty (TKA). The study will assess the impact of combined spinal-epidural anesthesia, adductor canal block, and multimodal intravenous analgesia on postoperative knee range of motion (ROM). Secondary outcomes include patient satisfaction, opioid consumption, Oxford Knee Score (OKS), activity levels, and visual analog scale (VAS) pain scores.

Adductor Canal Block

Ultrasound-guided adductor canal catheter placement and continuous infusion of bupivacaine .

Group Type ACTIVE_COMPARATOR

Regional anethesia

Intervention Type PROCEDURE

This single-center, prospective, randomized controlled trial aims to compare the effects of three different postoperative analgesia techniques following spinal anesthesia in patients undergoing total knee arthroplasty (TKA). The study will assess the impact of combined spinal-epidural anesthesia, adductor canal block, and multimodal intravenous analgesia on postoperative knee range of motion (ROM). Secondary outcomes include patient satisfaction, opioid consumption, Oxford Knee Score (OKS), activity levels, and visual analog scale (VAS) pain scores.

Multimodal Intravenous Analgesia

Continuous intravenous tramadol infusion with rescue analgesia as required.

Group Type SHAM_COMPARATOR

Regional anethesia

Intervention Type PROCEDURE

This single-center, prospective, randomized controlled trial aims to compare the effects of three different postoperative analgesia techniques following spinal anesthesia in patients undergoing total knee arthroplasty (TKA). The study will assess the impact of combined spinal-epidural anesthesia, adductor canal block, and multimodal intravenous analgesia on postoperative knee range of motion (ROM). Secondary outcomes include patient satisfaction, opioid consumption, Oxford Knee Score (OKS), activity levels, and visual analog scale (VAS) pain scores.

Interventions

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Regional anethesia

This single-center, prospective, randomized controlled trial aims to compare the effects of three different postoperative analgesia techniques following spinal anesthesia in patients undergoing total knee arthroplasty (TKA). The study will assess the impact of combined spinal-epidural anesthesia, adductor canal block, and multimodal intravenous analgesia on postoperative knee range of motion (ROM). Secondary outcomes include patient satisfaction, opioid consumption, Oxford Knee Score (OKS), activity levels, and visual analog scale (VAS) pain scores.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled for primary total knee arthroplasty
* Age ≥ 18 years
* American Society of Anesthesiologists (ASA) physical status I-III
* Accepting neuraxial anesthesia

Exclusion Criteria

* Skin infection at the planned injection site
* Sepsis
* Coagulopathy
* Refusal of neuraxial anesthesia
* Severe hypovolemia
* Demyelinating central nervous system disease
* Age under 18 years
* Illiterate in Turkish
* Non-cooperative patients
* Known allergy or hypersensitivity to bupivacaine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konya City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yasin Tire, MD

Assoc. Prof. Dr. Yasin Tire

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yasin Tire

Konya, Meram, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Yasin Tire

Role: CONTACT

05055367970

Facility Contacts

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Yasin Tire

Role: primary

05055367970

Osman Çiçekler

Role: backup

Other Identifiers

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Study Epidural

Identifier Type: -

Identifier Source: org_study_id

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