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

Surgery Clinical Trial

Official title:

Comparing Combined Adductor Canal & Sciatic Nerve Block and Femoral & Sciatic Nerve Block for Postoperative Analgesia in Patients Undergoing Total Knee Replacement Surgery; A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648708
• Other study ID #: 2022-361
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: October 23, 2023

Study information

• Verified date: November 2022
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: Gokhan Sertcakacilar, MD
• Phone: 00905053130818
• Email: drgokhansertcakacilar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: October 23, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder
• Pain, Postoperative
• Post Operative Pain
• Surgery
• Total Knee Replacement

Intervention

Procedure:
• Combine Adductor Canal & Sciatic Nerve Block
The investigators will perform a combined adductor canal & sciatic nerve block on that patient group for postoperative analgesia
• Combine Femoral & Sciatic Nerve Block
The investigators will perform a combined femoral & sciatic nerve block on that patient group for postoperative analgesia

Drug:
• 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
• 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

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects due to postoperative opioid consumption, rescue analgesic requirements, hemodynamic parameters and satisfaction with analgesic method	Opioid side effects ( Nausea, Vomiting, Constipation, Itching, Mental cloudiness, Sweating, Fatigue, Drowsiness ) will be evaluated and noted as none-mild-moderate-severe for 72 hours	Three days postoperatively
Primary	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	The secondary outcome measure will be total opioid consumption in the first 72 hours 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	Three days postoperatively