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
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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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:
The patient will be considered ready for discharge after completing protocol endpoints and walking at least 3 meters without support.
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 →Olfa kaabachi, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
Adductor canal block with dexamethasone
Adductor canal block with saline solution
morphine consumption
postoperative consumption of morphine
Time frame: 48 hours
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
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
knee mouvement
Range of mouvement of the knee
Time frame: preoperatively, on day 1 and day 7 postoperatively
walk
Numbers of steps
Time frame: day 1 and day 2 postoperatively
Patient's satisfaction
3 level scale :0: not satisfied; 1: mild satisfaction; 2: satisfied
Time frame: 48 hours postoperatively
Blood glucose level
Blood glucose level
Time frame: 1 hour, 6 hours,12 hours,18 hours, 24 hours postoperatively
pain at home
NRS at mouvement \[ NRS =0 no pain ; NRS =10 worsE pain\]
Time frame: 7 days postoperatively
quality of recovery
QoR15 score \[ 136-150 excellent recovery - 0-89 poor recovery\]
Time frame: day one
neuropathic Chronic pain
DN4 questionnaire \[ no neuropathic pain 0 - neuropathic pain \>4\]
Time frame: 6 MONTHS
chronic pain
NRS on mouvement \[ NRS =0 no pain ; NRS =10 worse pain\]
Time frame: 6 months
postoperative quality of life
SF-12 score \[0 to 100, with higher scores indicating better physical and mental health functioning\]
Time frame: 6 months
knee fonction
KOOS PS score \[\[0 to 100, with higher scores indicating better knee function\]functioning\]
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Olfa kaabachi, MD