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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gokhan Sertcakacilar, MD; Phone Number: 00905053130818; Email: drgokhansertcakacilar@gmail.com
• Study Contact Backup: Name: Bilal Kasapoglu, MD; Phone Number: 00905434836797; Email: bilalkasapoglu@hotmail.com

Study Locations

• Turkey
  • Bakirkoy
    • Istanbul, Bakirkoy, Turkey, 34147
      • Recruiting
      • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
      • Contact: Gokhan Sertcakacilar, MD; Phone Number: 00905053130818; Email: drgokhansertcakacilar@gmail.com
      • Principal Investigator: Gokhan Sertcakacilar
      • Sub-Investigator: Bilal Kasapoglu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group AS; 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; The investigators will perform a combined adductor canal & 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; 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
Active Comparator: Group FS; The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia	Procedure: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Anticipated): August 21, 2023
• Study Completion (Anticipated): October 23, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Femoral Nerve Block; Sciatic Nerve Block; Adductor Canal Block; General anesthesia; Orthopedic surgery; Post Operative Analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Musculoskeletal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine; Bupivacaine
• Other Study ID Numbers: 2022-361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data available from the publication date can start. NRS scores and Opioid consumption and side effects will be shared. If requested, data will be shared with anesthesiologists dealing with postoperative analgesia in patients undergoing total knee replacement surgery
• IPD Sharing Time Frame: Two year within the publication date.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No