Combined Adductor&Sciatic Nerve Block vs Femoral&Sciatic Nerve Block in Total Knee Replacement Surgery

NCT05648708 | Completed DMC

• 1 other identifier: 2022-361
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Knee joints, one of the largest and most functional joints of the human body, have great features to provide ideal body posture and movement. In patients with knee osteoarthritis in whom pain and functional loss continue to increase despite conservative and medical burden, they are evaluated by orthopedic surgeons for surgical treatment. Total knee replacement (TKR) surgery is aimed to eliminate the existing pain, restore and carry the movements, to protect the characteristics of the deformities and the quality of life. Pain can be very severe after TKR surgery, which is very common in the middle and elderly patient population today. In the postoperative period, untreated pain prevents early physical therapy practices and restricts postoperative knee rehabilitation and recovery, but it also has negative effects on the respiratory, gastrointestinal, renal, and central nervous systems. Effective management of postoperative acute pain can reduce these complications and the risk of developing chronic pain. In this study, investigators hypothesized that combined adductor canal and sciatic nerve block, applied with postoperative ultrasound guidance to patients who will undergo TKR surgery under general anesthesia, will provide effective analgesia, less opioid consumption, and faster ambulation time, similar to combined femoral and sciatic nerve block.

Conditions

Orthopedic Disorder; Total Knee Replacement; Post Operative Pain; Surgery

Keywords

Femoral Nerve Block; Sciatic Nerve Block; Adductor Canal Block; General anesthesia; Orthopedic surgery; Post Operative Analgesia

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure of the study is the patients' postoperative pain scores (NRS)

  Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 48, 72th hours. NRS assessment score ranges from 0-10. 0 = no pain 10 = worst pain imaginable

  72 hours postoperatively

Secondary Outcomes (1)

• The secondary outcome measure will be total opioid consumption in the first 72 hours postoperatively

  Three days postoperatively

Other Outcomes (1)

• Side effects due to postoperative opioid consumption, rescue analgesic requirements, hemodynamic parameters and satisfaction with analgesic method

  Three days postoperatively

Study Arms (2)

Group AS

ACTIVE COMPARATOR

The investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia

Procedure: Combine Adductor Canal & Sciatic Nerve Block; Drug: Bupivacaine and prilocaine hydrochloride

Group FS

ACTIVE COMPARATOR

The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia

Procedure: Combine Femoral & Sciatic Nerve Block; Drug: Bupivacaine and prilocaine hydrochloride

Interventions

Combine Adductor Canal & Sciatic Nerve Block PROCEDURE

The investigators will perform a combined adductor canal \& sciatic nerve block on that patient group for postoperative analgesia

Group AS

Combine Femoral & Sciatic Nerve Block PROCEDURE

The investigators will perform a combined femoral \& sciatic nerve block on that patient group for postoperative analgesia

Group FS

Bupivacaine and prilocaine hydrochloride DRUG

The investigators will perform a combined adductor canal \& sciatic nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride

Group AS

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages of 40-85
• ASA I-III
• Patients who will undergo total knee replacement surgery under general anesthesia

You may not qualify if:

• Patients with deformity and pathology in the thigh region
• Clinically known local anesthetic allergy
• Clinically diagnosis of opioid, alcohol and substance dependence
• Patients who cannot perceive and evaluate pain such as psychiatric illness, mental retardation, dementia
• Morbid obesity (body mass index\> 40 kg m2)

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

Related Publications (5)

• Auroy Y, Narchi P, Messiah A, Litt L, Rouvier B, Samii K. Serious complications related to regional anesthesia: results of a prospective survey in France. Anesthesiology. 1997 Sep;87(3):479-86. doi: 10.1097/00000542-199709000-00005.

  PMID: 9316950 BACKGROUND

• Sladjana UZ, Ivan JD, Bratislav SD. Microanatomical structure of the human sciatic nerve. Surg Radiol Anat. 2008 Nov;30(8):619-26. doi: 10.1007/s00276-008-0386-6. Epub 2008 Jul 23.

  PMID: 18648720 BACKGROUND

• Currin SS, Mirjalili SA, Meikle G, Stringer MD. Revisiting the surface anatomy of the sciatic nerve in the gluteal region. Clin Anat. 2015 Jan;28(1):144-9. doi: 10.1002/ca.22449. Epub 2014 Aug 8.

  PMID: 25131147 BACKGROUND

• Bozkurt M, Yilmazlar A, Bilgen OF. [Comparing the effects of analgesia techniques with controlled intravenous and epidural on postoperative pain and knee rehabilitation after total knee arthroplasty]. Eklem Hastalik Cerrahisi. 2009;20(2):64-70. Turkish.

  PMID: 19619108 BACKGROUND

• Gray AT, Collins AB. Ultrasound-guided saphenous nerve block. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):148; author reply 148. doi: 10.1053/rapm.2003.50000. No abstract available.

  PMID: 12677627 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases; Pain, Postoperative

Interventions

Bupivacaine; Prilocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 13, 2022
• Study Start: November 14, 2022
• Primary Completion: August 21, 2023
• Study Completion: October 23, 2023
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Two year within the publication date.

Locations

TU (1)