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USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tramadol
Morfin
Sponsored by
Siirt Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Adductor canal block, Infiltration popliteal artery capsule knee block, Tramadol, Bupivacaine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: aged between 18-75 years who were scheduled for elective total knee arthroplasty in Bolu Abant Izzet Baysal University Training and Research Hospital Orthopaedics and Traumatology Clinics Exclusion Criteria: Patients with hypersensitivity to the drugs to be used in the study or the substances in their composition pregnant women severe cardiac, pulmonary, hepatic, and renal disease a history of chronic opioid use and chronic pain syndrome patients who were not suitable for regional anesthesia (bleeding diathesis, infection in the procedure area), and those who could not apply patient controlled anesthesia

Sites / Locations

  • Bolu Abant İzzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

adductor canal block and infiltration popliteal artery capsule knee block

Control

Arm Description

Adductor canal block and infiltration popliteal artery capsule knee block were performed accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application.

No block performed

Outcomes

Primary Outcome Measures

tramadol consumption
tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours
using morphine as rescue analgesia
rescue analgesia was evaluated for 0-1 hour, 1-12 hours, and 12-24, the number of patients who used morphine

Secondary Outcome Measures

Full Information

First Posted
July 4, 2023
Last Updated
July 13, 2023
Sponsor
Siirt Training and Research Hospital
Collaborators
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05956275
Brief Title
USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia
Official Title
Comparison Between USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia in Total Knee Prosthesis Under General Anesthesia: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siirt Training and Research Hospital
Collaborators
Abant Izzet Baysal University

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
The purpose was to evaluate the effect of USG-guided adductor canal block and infiltration popliteal artery capsule knee block combination on postoperative analgesia before total knee arthroplasty.
Detailed Description
In the present study, the purpose was to evaluate the effect of Ultrasound(USG)-guided adductor canal block(ACB) and infiltration popliteal artery capsule knee block(IPACK) combination on postoperative analgesia before total knee arthroplasty(TKA). A total of 40 patients,who were aged 18-75 with the American Society of Anesthesiologists score(ASA) I-III physical status,and who were scheduled for TKA under general anesthesia,were included in the present study.ACB and IPACK were performed in group A(ACB+IPACK) accompanied by USG, Bupivacaine and 10 mL of 0.9% sodium chloride were applied in each block application.No block was applied to the patients in group B.Patient-controlled analgesia was administered to both groups 30 minutes before the end of the surgery.Tramadol HCL was infused at a concentration of 4mg/ml.A bolus of 20 mg of tramadol hydrochloride was given with a lock-in interval of 30 minutes.Postoperative systolic arterial pressure(SAP),diastolic arterial pressure(DAP),mean arterial pressure(MAP),heart rate(HR),visual analog scale(VAS),analgesic consumption,nausea,vomiting, and patient satisfaction scores were recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Adductor canal block, Infiltration popliteal artery capsule knee block, Tramadol, Bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adductor canal block and infiltration popliteal artery capsule knee block
Arm Type
Active Comparator
Arm Description
Adductor canal block and infiltration popliteal artery capsule knee block were performed accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
No block performed
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
ACB and IPACK were performed in USG-guided adductor canal block and infiltration popliteal artery capsule knee block accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application.
Intervention Type
Drug
Intervention Name(s)
Morfin
Intervention Description
No block was applied to the patients in control
Primary Outcome Measure Information:
Title
tramadol consumption
Description
tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours
Time Frame
24 hours
Title
using morphine as rescue analgesia
Description
rescue analgesia was evaluated for 0-1 hour, 1-12 hours, and 12-24, the number of patients who used morphine
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged between 18-75 years who were scheduled for elective total knee arthroplasty in Bolu Abant Izzet Baysal University Training and Research Hospital Orthopaedics and Traumatology Clinics Exclusion Criteria: Patients with hypersensitivity to the drugs to be used in the study or the substances in their composition pregnant women severe cardiac, pulmonary, hepatic, and renal disease a history of chronic opioid use and chronic pain syndrome patients who were not suitable for regional anesthesia (bleeding diathesis, infection in the procedure area), and those who could not apply patient controlled anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kutay Engin Özturan, Professor
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cengiz Işık, Professor
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Asım İlker İtal, MD
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mustafa Türkoğlu, MD
Organizational Affiliation
Bolu Abant İzzet Baysal University
Official's Role
Study Chair
Facility Information:
Facility Name
Bolu Abant İzzet Baysal University
City
Bolu
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study is a thesis that I did and presented two years ago. The raw data has not been backed up after going through statistical analysis.
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USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia

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