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

Primary Purpose

Orthopedic Disorder, Total Knee Replacement, Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combine Adductor Canal & Sciatic Nerve Block
Combine Femoral & Sciatic Nerve Block
Bupivacaine and prilocaine hydrochloride
Bupivacaine and prilocaine hydrochloride
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Orthopedic Disorder focused on measuring Femoral Nerve Block, Sciatic Nerve Block, Adductor Canal Block, General anesthesia, Orthopedic surgery, Post Operative Analgesia

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group AS

Group FS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2022
Last Updated
December 16, 2022
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05648708
Brief Title
Combined Adductor&Sciatic Nerve Block vs Femoral&Sciatic Nerve Block in Total Knee Replacement Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
August 21, 2023 (Anticipated)
Study Completion Date
October 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group AS
Arm Type
Active Comparator
Arm Description
The investigators will perform an adductor canal block and sciatic nerve block on that patient group for postoperative analgesia
Arm Title
Group FS
Arm Type
Active Comparator
Arm Description
The investigators will perform femoral and sciatic nerve blocks on that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Combine Adductor Canal & Sciatic Nerve Block
Intervention Description
The investigators will perform a combined adductor canal & sciatic nerve block on that patient group for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Combine Femoral & Sciatic Nerve Block
Intervention Description
The investigators will perform a combined femoral & sciatic nerve block on that patient group for postoperative analgesia
Intervention Type
Drug
Intervention Name(s)
Bupivacaine and prilocaine hydrochloride
Intervention Description
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
Intervention Name(s)
Bupivacaine and prilocaine hydrochloride
Intervention Description
The investigators will perform a combined femoral & sciatic nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride
Primary Outcome Measure Information:
Title
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
Description
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
Time Frame
72 hours postoperatively
Secondary Outcome Measure Information:
Title
The secondary outcome measure will be total opioid consumption in the first 72 hours postoperatively
Description
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
Time Frame
Three days postoperatively
Other Pre-specified Outcome Measures:
Title
Side effects due to postoperative opioid consumption, rescue analgesic requirements, hemodynamic parameters and satisfaction with analgesic method
Description
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
Time Frame
Three days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gokhan Sertcakacilar, MD
Phone
00905053130818
Email
drgokhansertcakacilar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bilal Kasapoglu, MD
Phone
00905434836797
Email
bilalkasapoglu@hotmail.com
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gokhan Sertcakacilar, MD
Phone
00905053130818
Email
drgokhansertcakacilar@gmail.com
First Name & Middle Initial & Last Name & Degree
Gokhan Sertcakacilar
First Name & Middle Initial & Last Name & Degree
Bilal Kasapoglu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
9316950
Citation
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.
Results Reference
background
PubMed Identifier
18648720
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.
Results Reference
background
PubMed Identifier
25131147
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.
Results Reference
background
PubMed Identifier
19619108
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.
Results Reference
background
PubMed Identifier
12677627
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.
Results Reference
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Combined Adductor&Sciatic Nerve Block vs Femoral&Sciatic Nerve Block in Total Knee Replacement Surgery

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