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

NCT ID: NCT05648708

Last Updated: 2025-06-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-10-23

Brief Summary

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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.

Detailed Description

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As a result of the power analysis investigators conducted for this study, the minimum sample size was calculated as 34 people for each group, 68 people in total, at the 95% confidence interval.

68 patients who meet the inclusion criteria will be included in our study. Patients will be randomized and divided into 2 groups. Accordingly, femoral and sciatic nerve blocks will be applied to 34 patients, and adductor canal and sciatic nerve blocks will be applied to 34 patients.

Conditions

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Orthopedic Disorder Total Knee Replacement Post Operative Pain Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group AS

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

Group Type ACTIVE_COMPARATOR

Combine Adductor Canal & Sciatic Nerve Block

Intervention Type PROCEDURE

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

Bupivacaine and prilocaine hydrochloride

Intervention Type 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 FS

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

Group Type ACTIVE_COMPARATOR

Combine Femoral & Sciatic Nerve Block

Intervention Type PROCEDURE

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

Bupivacaine and prilocaine hydrochloride

Intervention Type DRUG

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

Interventions

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Combine Adductor Canal & Sciatic Nerve Block

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

Intervention Type PROCEDURE

Combine Femoral & Sciatic Nerve Block

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

Intervention Type PROCEDURE

Bupivacaine and prilocaine hydrochloride

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

Intervention Type DRUG

Bupivacaine and prilocaine hydrochloride

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gokhan Sertcakacilar, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 9316950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18648720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25131147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19619108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12677627 (View on PubMed)

Other Identifiers

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2022-361

Identifier Type: -

Identifier Source: org_study_id

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