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Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

Primary Purpose

Knee Replacement, Total, Pain, Postoperative, Anesthesia, Regional

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Bupivacaine Injection

About this trial

This is an interventional treatment trial for Knee Replacement, Total focused on measuring femoral nerve block, adductor canal block, total knee arthroplasty

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

ASA(American Society of Anesthesiologists) Classification I-II
Age: <55 years
Unilateral total knee arthroplasty

Exclusion Criteria:

Does not approve the study
Pregnant
Emergency
ASA III-IV
History of local anesthetic allergy
Infection in the block area
Coagulation disorder
Morbid obesity (body mass index> 40 kg / m²)
Severe organ failure
Previous neurological deficit
Psychiatric disease
History of chronic pain

Sites / Locations

SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Femoral group

Adductor group

Arm Description

Outcomes

Primary Outcome Measures

Tramadol consumption

Postoperative tramadol consumption with patient controlled analgesia

VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain)

VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is less than four is adequate analgesia

Rescue analgesic requirement

If VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is is four or more, paracetamol 1000 mg is administered

Secondary Outcome Measures

Postoperative nausea and vomiting

Frequency of postoperative nausea and vomiting

Full Information

NCT ID

NCT04286035

First Posted

February 21, 2020

Last Updated

March 11, 2020

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04286035

Brief Title

Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

Official Title

Comparison of the Effects of Femoral Nerve Block and Adductor Canal Block on Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

April 2, 2019 (Actual)

Primary Completion Date

September 29, 2019 (Actual)

Study Completion Date

October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The frequency of femoral nerve block and adductor canal block for analgesia after TKA(total knee arthroplasty) increases with the use of ultrasonography in regional anesthesia. In this study, we aimed to compare the effects of femoral nerve block and adductor canal block on postoperative analgesia in patients undergoing unilateral knee arthroplasty.

6. Conditions and Keywords

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

Knee Replacement, Total, Pain, Postoperative, Anesthesia, Regional

Keywords

femoral nerve block, adductor canal block, total knee arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Femoral group

Arm Type

Active Comparator

Arm Title

Adductor group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Injection

Intervention Description

Femoral nerve block with 20 ml %0.375 bupivacaine

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Injection

Intervention Description

Adductor canal block with 20 ml %0.375 bupivacaine

Primary Outcome Measure Information:

Title

Tramadol consumption

Description

Postoperative tramadol consumption with patient controlled analgesia

Time Frame

24 hours after operation

Title

VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain)

Description

VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is less than four is adequate analgesia

Time Frame

24 hours after operation

Title

Rescue analgesic requirement

Description

If VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is is four or more, paracetamol 1000 mg is administered

Time Frame

24 hours after operation

Secondary Outcome Measure Information:

Title

Postoperative nausea and vomiting

Description

Frequency of postoperative nausea and vomiting

Time Frame

24 hours after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA(American Society of Anesthesiologists) Classification I-II Age: <55 years Unilateral total knee arthroplasty Exclusion Criteria: Does not approve the study Pregnant Emergency ASA III-IV History of local anesthetic allergy Infection in the block area Coagulation disorder Morbid obesity (body mass index> 40 kg / m²) Severe organ failure Previous neurological deficit Psychiatric disease History of chronic pain

Facility Information:

Facility Name

SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

City

Istanbul

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

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