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Perineural Dexamethasone in the Adductor Canal Block

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
group Dexamethasone
group Controle
Sponsored by
Olfa kaabachi, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring knee arthroplasty, glucocorticoids, adductor canal block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients scheduled for unilateral TKA Surgery under spinal anesthesia ASA class I, II, and III patients Exclusion Criteria: Patient refusal to participate in the study Contraindication to regional anesthesia Allergies to the products used Bilateral TKA Revision TKA TKA in the context of inflammatory or post-traumatic disease BMI > 45 Poorly controlled diabetic patients with HbA1c > 8% Patients on corticosteroid therapy or who have received an intra-articular injection of corticosteroids

Sites / Locations

  • KAABACHI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group Dexamethasone

group Controle

Arm Description

adductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of "dexamethasone" (8 mg)

adductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of 0.9% saline solution

Outcomes

Primary Outcome Measures

morphine consumption
postoperative consumption of morphine

Secondary Outcome Measures

NRS at rest
Numerical rate scale at rest [ NRS =0 no pain ; NRS =10 worse pain]
NRS on mouvement
Numerical rate scale during knee flexion [ NRS =0 no pain ; NRS =10 worse pain]
knee mouvement
Range of mouvement of the knee
walk
Numbers of steps
Patient's satisfaction
3 level scale :0: not satisfied; 1: mild satisfaction; 2: satisfied
Blood glucose level
Blood glucose level
pain at home
NRS at mouvement [ NRS =0 no pain ; NRS =10 worsE pain]
quality of recovery
QoR15 score [ 136-150 excellent recovery - 0-89 poor recovery]
neuropathic Chronic pain
DN4 questionnaire [ no neuropathic pain 0 - neuropathic pain >4]
chronic pain
NRS on mouvement [ NRS =0 no pain ; NRS =10 worse pain]
postoperative quality of life
SF-12 score [0 to 100, with higher scores indicating better physical and mental health functioning]
knee fonction
KOOS PS score [[0 to 100, with higher scores indicating better knee function]functioning]

Full Information

First Posted
May 9, 2023
Last Updated
October 9, 2023
Sponsor
Olfa kaabachi, MD
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1. Study Identification

Unique Protocol Identification Number
NCT06079047
Brief Title
Perineural Dexamethasone in the Adductor Canal Block
Official Title
Perineural Dexamethasone in the Adductor Canal Block for Postoperative Pain in Knee Arthroplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olfa kaabachi, MD

4. Oversight

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

5. Study Description

Brief Summary
Postoperative pain management in total knee arthroplasty (TKA) surgery is a real challenge for the anesthesiologist. Effective pain control must be provided while preserving the mobility to ensure early rehabilitation. The adductor canal block is an effective way to induce sensory block without motor block. However, the major disadvantage of this block is the duration of sensory block which may be insufficient for postoperative pain management in TKA surgery. Many studies have focused on finding molecules that can prolong sensory block without the need for a perineural catheter and dexamethasone is among the most studied molecules(1, 2). Hence, our study aims to evaluate the added value of perineural dexamethasone in the adductor canal block in TKA surgery. [
Detailed Description
Using a computer-generated sequence of random numbers, the patients included will be randomly allocated to get an adductor canal block using : Group D: 10 ml of 0.5% bupivacaine + 10 ml of 0.9% normal saline solution + 8 mg of dexamethasone (equivalent to 2 ml) Group C: 10 ml of 0.5% bupivacaine + 10 ml of 0.9% normal saline solution + 2 ml of 0.9% normal saline solution All patients included in the study will initially be evaluated at the anesthesia outpatient clinic with correction of any existing health issues. A pre-anesthesia visit will be conducted the day before the procedure for all patients, providing them with information about the protocol of our study and obtaining their consent to participate. Upon arrival at the operating room, non-invasive monitoring of blood pressure, pulse oximetry, and ECG tracing will be performed and also a blood glucose level measurement. An 18-gauge peripheral intravenous line will be established, and 0.03 mg per kg midazolam was administrated. All patients will receive spinal anesthesia. Depending on the patient's condition, investigators will opte for: A single shot spinal anesthesia using 0.5% bupivacaine (11 mg) with fentanyl (25 µg) for patients under 65 years of age with ASA I and II Continuous spinal anesthesia with drug titration for patients over 65 years of age or with ASA III classification. None of patients will receive intravenous dexamethasone during the perioperative period. The decision to use a tourniquet and use of cement will be left to the surgeon. In the immediate postoperative period, all patients will receive an adductor canal block with a high-frequency probe. The patients will be positioned in a supine position with the leg slightly externally rotated. The probe will be placed transversely on the inguinal fold. The femoral vessels (artery and vein) will be identified. The different muscular structures delimiting the adductor canal will be visualized: the sartorius muscle that covers the femoral artery and the medial vastus muscle laterally. The saphenous nerve, which is usually hyperechoic, is located most often at the lateral edge of the artery in the fascia between the sartorius and medial vastus muscles. A 100 mm neurostimulation needle was used and 22 ml solution was injected into the adductor canal. Patients will be transferred to continuous care unit for 48 hours. Post operative analgesia will include: Paracetamol 1g IV every 6 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks Diclofenac sodium (50 mg) *2 per day for 5 days PCA morphine (Patient Controlled Analgesia), as a rescue analgesia. The first rise will be allowed on day 1 (18 h postoperatively) and the patient will be asked to wander with a walking frame for a distance of at least 3 meters (about 10 steps). The patient will be considered ready for discharge after completing protocol endpoints and walking at least 3 meters without support.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
knee arthroplasty, glucocorticoids, adductor canal block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group Dexamethasone
Arm Type
Experimental
Arm Description
adductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of "dexamethasone" (8 mg)
Arm Title
group Controle
Arm Type
Active Comparator
Arm Description
adductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of 0.9% saline solution
Intervention Type
Procedure
Intervention Name(s)
group Dexamethasone
Intervention Description
Adductor canal block with dexamethasone
Intervention Type
Procedure
Intervention Name(s)
group Controle
Intervention Description
Adductor canal block with saline solution
Primary Outcome Measure Information:
Title
morphine consumption
Description
postoperative consumption of morphine
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
NRS at rest
Description
Numerical rate scale at rest [ NRS =0 no pain ; NRS =10 worse pain]
Time Frame
1 hour, 3 hours, 6 hours, 9 hours,12 hours, 24 hours, 36 hours and 48 hours postoperatively
Title
NRS on mouvement
Description
Numerical rate scale during knee flexion [ NRS =0 no pain ; NRS =10 worse pain]
Time Frame
1 hour, 3 hous, 6 hours, 9 hours,12 hours, 24 hours, 36 houes and 48 hours postoperatively
Title
knee mouvement
Description
Range of mouvement of the knee
Time Frame
preoperatively, on day 1 and day 7 postoperatively
Title
walk
Description
Numbers of steps
Time Frame
day 1 and day 2 postoperatively
Title
Patient's satisfaction
Description
3 level scale :0: not satisfied; 1: mild satisfaction; 2: satisfied
Time Frame
48 hours postoperatively
Title
Blood glucose level
Description
Blood glucose level
Time Frame
1 hour, 6 hours,12 hours,18 hours, 24 hours postoperatively
Title
pain at home
Description
NRS at mouvement [ NRS =0 no pain ; NRS =10 worsE pain]
Time Frame
7 days postoperatively
Title
quality of recovery
Description
QoR15 score [ 136-150 excellent recovery - 0-89 poor recovery]
Time Frame
day one
Title
neuropathic Chronic pain
Description
DN4 questionnaire [ no neuropathic pain 0 - neuropathic pain >4]
Time Frame
6 MONTHS
Title
chronic pain
Description
NRS on mouvement [ NRS =0 no pain ; NRS =10 worse pain]
Time Frame
6 months
Title
postoperative quality of life
Description
SF-12 score [0 to 100, with higher scores indicating better physical and mental health functioning]
Time Frame
6 months
Title
knee fonction
Description
KOOS PS score [[0 to 100, with higher scores indicating better knee function]functioning]
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for unilateral TKA Surgery under spinal anesthesia ASA class I, II, and III patients Exclusion Criteria: Patient refusal to participate in the study Contraindication to regional anesthesia Allergies to the products used Bilateral TKA Revision TKA TKA in the context of inflammatory or post-traumatic disease BMI > 45 Poorly controlled diabetic patients with HbA1c > 8% Patients on corticosteroid therapy or who have received an intra-articular injection of corticosteroids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
OLFA KAABACHI, MD
Phone
216 98317381
Email
olfa.kaabachi@gnet.tn
Facility Information:
Facility Name
KAABACHI
City
Tunis
State/Province
La Mannouba
ZIP/Postal Code
2010
Country
Tunisia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
olfa KAABACHI, MD
Phone
216 98317381
Email
olfa.kaabach@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Perineural Dexamethasone in the Adductor Canal Block

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