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Post Operative PainNCT06079047

Perineural Dexamethasone in the Adductor Canal Block

A study testing group Dexamethasone in people with Post Operative Pain, run by Olfa kaabachi, MD at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Post Operative Pain
What is being tested?
group Dexamethasone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTunisia
Study dates
15 Dec 2023to 31 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients scheduled for unilateral TKA
  • Surgery under spinal anesthesia
  • ASA class I, II, and III patients

Who cannot join

  • 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
Show all 9Show fewer
  • BMI > 45
  • Poorly controlled diabetic patients with HbA1c > 8%
  • Patients on corticosteroid therapy or who have received an intra-articular injection of corticosteroids

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • KAABACHI

    Tunis, La Mannouba, 2010

Other trials in Tunisia

About this study

Official title: Perineural Dexamethasone in the Adductor Canal Block for Postoperative Pain in Knee Arthroplasty Surgery

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.

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Read the 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:

  1. Paracetamol 1g IV every 6 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks
  2. Diclofenac sodium (50 mg) *2 per day for 5 days
  3. 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.

Being tested
group Dexamethasone, group Controle
Keywords
knee arthroplasty, glucocorticoids, adductor canal block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • group DexamethasoneProcedure or surgery

    Adductor canal block with dexamethasone

  • group ControleProcedure or surgery

    Adductor canal block with saline solution

Study groups in NCT06079047
Study groupRoleWhat they receive
group DexamethasoneExperimentaladductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of "dexamethasone" (8 mg)
Receives: Procedure: group Dexamethasone
group ControleActive comparatoradductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of 0.9% saline solution
Receives: Procedure: group Controle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. morphine consumption

    postoperative consumption of morphine

    Measured: 48 hours

Secondary outcomes (12)
  1. NRS at rest

    Numerical rate scale at rest [ NRS =0 no pain ; NRS =10 worse pain]

    Measured: 1 hour, 3 hours, 6 hours, 9 hours,12 hours, 24 hours, 36 hours and 48 hours postoperatively

  2. NRS on mouvement

    Numerical rate scale during knee flexion [ NRS =0 no pain ; NRS =10 worse pain]

    Measured: 1 hour, 3 hous, 6 hours, 9 hours,12 hours, 24 hours, 36 houes and 48 hours postoperatively

  3. knee mouvement

    Range of mouvement of the knee

    Measured: preoperatively, on day 1 and day 7 postoperatively

  4. walk

    Numbers of steps

    Measured: day 1 and day 2 postoperatively

  5. Patient's satisfaction

    3 level scale :0: not satisfied; 1: mild satisfaction; 2: satisfied

    Measured: 48 hours postoperatively

  6. Blood glucose level

    Blood glucose level

    Measured: 1 hour, 6 hours,12 hours,18 hours, 24 hours postoperatively

  7. pain at home

    NRS at mouvement [ NRS =0 no pain ; NRS =10 worsE pain]

    Measured: 7 days postoperatively

  8. quality of recovery

    QoR15 score [ 136-150 excellent recovery - 0-89 poor recovery]

    Measured: day one

  9. neuropathic Chronic pain

    DN4 questionnaire [ no neuropathic pain 0 - neuropathic pain >4]

    Measured: 6 MONTHS

  10. chronic pain

    NRS on mouvement [ NRS =0 no pain ; NRS =10 worse pain]

    Measured: 6 months

  11. postoperative quality of life

    SF-12 score [0 to 100, with higher scores indicating better physical and mental health functioning]

    Measured: 6 months

  12. knee fonction

    KOOS PS score [[0 to 100, with higher scores indicating better knee function]functioning]

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start15 Dec 2023
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079047
Sponsor's protocol ID
CE-IMKO- 111/2023
Status last verified
Feb 2024
First submitted
9 May 2023
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing group Dexamethasone in people with Post Operative Pain, run by Olfa kaabachi, MD at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

morphine consumption (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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