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

Not Applicable

Recruiting

• Conditions: Orthopedic Disorder; Total Knee Replacement; Post Operative Pain; Surgery
• Interventions: Procedure: Combine Adductor Canal & Sciatic Nerve Block; Procedure: Combine Femoral & Sciatic Nerve Block; Drug: Bupivacaine and prilocaine hydrochloride

• Registration Number: NCT05648708
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-14
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-13
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-20
• Primary Completion: 2023-08-21
• Study Completion: 2023-10-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group AS	Combine Adductor Canal & Sciatic Nerve Block	The investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia
Group AS	Bupivacaine and prilocaine hydrochloride	The investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia
Group FS	Combine Femoral & Sciatic Nerve Block	The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia
Group FS	Bupivacaine and prilocaine hydrochloride	The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)	72 hours postoperatively	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

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measure will be total opioid consumption in the first 72 hours postoperatively	Three days postoperatively	PCA device will be prepared with 4 mg tramadol (400 mg/100 cc) per ml and total opioid consumption for 72 hours will be noted

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 Istanbul, Bakirkoy, Turkey