NCT07115771

Brief Summary

Total knee arthroplasty (TKA) is a surgical procedure frequently associated with moderate-to-severe postoperative pain. While Adductor Canal Block (ACB) has demonstrated analgesic efficacy in TKA, the Erector Spinae Plane Block (ESPB) is also being utilized as part of multimodal analgesia for postoperative pain management in lower extremity surgeries. Currently, there is a gap in the literature as no studies have directly compared the efficacy of ACB and ESPB for pain management following TKA. The primary objective of this study is to compare the efficacy of these two analgesic methods in the context of postoperative analgesia management after total knee arthroplasty.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Aug 2025May 2026

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

August 4, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

Postoperative Analgesiaadductor canal blockerector spinae plane blockTotal Knee Anthroplasty

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    Tramadol will be prepared as 5mg/ml and patient-controlled analgesia will be administered without basal infusion, with a locking time of 20 minutes and a bolus dose of 10mg.

    0, 2, 4, 8, 16, 24 and 48 hours

Secondary Outcomes (3)

  • Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

    The NRS scores of the patients will be evaluated at the postoperative 0, 2, 4, 8, 16, 24 and 48 hours.

  • Global recovery scoring system (patient satisfaction scale)

    The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 48th hour.

  • Determine the time to first postoperative mobilization (The Timed Up and Go - TUG test):

    The Timed Up and Go (TUG) test will be performed at the 20th minute after the preoperative block.

Study Arms (2)

Adductor canal block

ACTIVE COMPARATOR

Patients will receive an adductor canal block preoperatively.

Other: Postoperative analgesia management

Erector spinae plane block

ACTIVE COMPARATOR

Patients will receive a lumbosacral erector spinae plane block in the preoperative period.

Other: Postoperative analgesia management

Interventions

After determining the L5-S1 level with ultrasound guidance, an 80 mm block needle (Stimuplex Ultra®, Braun, Melsungen, Germany) will be advanced in a cranio-caudal direction. Following hydrodissection, 30 ml of 0.25% bupivacaine local anesthetic solution containing 7.5 mcg of epinephrine (1:200,000) will be administered.

Erector spinae plane block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who underwent total knee arthroplasty surgery
  • ASA I-II patients

You may not qualify if:

  • Patient refusal to participate in the study
  • Patients with coagulopathy
  • Patients history with local anesthetic allergy or toxicity
  • Patients with liver and kidney failure
  • Mentally disabled patients
  • Presence of infection at the injection site
  • Pregnant, suspected pregnant, or breastfeeding mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • Tran J, Chan VWS, Peng PWH, Agur AMR. Evaluation of the proximal adductor canal block injectate spread: a cadaveric study. Reg Anesth Pain Med. 2019 Dec 25:rapm-2019-101091. doi: 10.1136/rapm-2019-101091. Online ahead of print.

    PMID: 31879373BACKGROUND
  • Tao Y, Zheng SQ, Xu T, Wang G, Wang Y, Wu AS, Yue Y. Median effective volume of ropivacaine 0.5% for ultrasound-guided adductor canal block. J Int Med Res. 2018 Oct;46(10):4207-4213. doi: 10.1177/0300060518791685. Epub 2018 Aug 20.

    PMID: 30124351BACKGROUND
  • Gupta A, Kaur J, Kumar R. Unilateral sacral erector spinae plane block for lower limb surgery in children. Anaesth Rep. 2022 Dec 14;10(2):e12199. doi: 10.1002/anr3.12199. eCollection 2022 Jul-Dec.

    PMID: 36530341BACKGROUND
  • Browne W, Nair BKR. The Timed Up and Go test. Med J Aust. 2019 Jan;210(1):13-14.e1. doi: 10.5694/mja2.12045. Epub 2018 Dec 28. No abstract available.

    PMID: 30636313BACKGROUND
  • Diwan S, Nair A. Lumbar erector spinae plane block obtunding knee and ankle reflexes. Saudi J Anaesth. 2021 Apr-Jun;15(2):222-224. doi: 10.4103/sja.SJA_79_20. Epub 2021 Apr 1.

    PMID: 34188648BACKGROUND
  • Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.

    PMID: 33585088BACKGROUND
  • Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.

    PMID: 36511494BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
he patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc prof

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

August 15, 2025

Primary Completion

April 15, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared

Locations