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CompletedNCT06079047Updated Nov 18, 2025

Perineural Dexamethasone in the Adductor Canal Block

An interventional study of group Dexamethasone and group Controle in Post Operative Pain, sponsored by Olfa kaabachi, MD. Completed at 1 site in Tunisia. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Olfa kaabachi, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Sex
All
01

Study 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.

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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.

02

Conditions studied

  • Post Operative Pain

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Keywords

  • knee arthroplasty
  • glucocorticoids
  • adductor canal block
03

In context

Pain, Postoperative

5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 66 is below the median of 75 across 4,346 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Olfa kaabachi, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    group Dexamethasone

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

    Procedure: group Dexamethasone

  • Active comparator
    group Controle

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

    Procedure: group Controle

Interventions

  • Proceduregroup Dexamethasone

    Adductor canal block with dexamethasone

  • Proceduregroup Controle

    Adductor canal block with saline solution

06

What researchers measure

Primary outcomes

  1. morphine consumption

    postoperative consumption of morphine

    Time frame: 48 hours

Secondary outcomes

  1. NRS at rest

    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

  2. NRS on mouvement

    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

  3. knee mouvement

    Range of mouvement of the knee

    Time frame: preoperatively, on day 1 and day 7 postoperatively

  4. walk

    Numbers of steps

    Time frame: day 1 and day 2 postoperatively

  5. Patient's satisfaction

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

    Time frame: 48 hours postoperatively

  6. Blood glucose level

    Blood glucose level

    Time frame: 1 hour, 6 hours,12 hours,18 hours, 24 hours postoperatively

  7. pain at home

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

    Time frame: 7 days postoperatively

  8. quality of recovery

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

    Time frame: day one

  9. neuropathic Chronic pain

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

    Time frame: 6 MONTHS

  10. chronic pain

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

    Time frame: 6 months

  11. postoperative quality of life

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

    Time frame: 6 months

  12. knee fonction

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

    Time frame: 6 months

07

Study locations

1 site
  • KAABACHI
    Tunis, La Mannouba 2010, Tunisia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06079047
Lead sponsor
Olfa kaabachi, MD
Responsible party
Olfa kaabachi, MD (PROFESSOR, University Tunis El Manar) — Sponsor-investigator
First posted
Oct 12, 2023
Start date
Dec 15, 2023
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025
Last update
Nov 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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