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.
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.
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:
- 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.
- Conditions
- Post Operative Pain
- 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 group | Role | What they receive |
|---|---|---|
| group Dexamethasone | Experimental | adductor 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 Controle | Active comparator | adductor 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.
morphine consumption
postoperative consumption of morphine
Measured: 48 hours
Secondary outcomes (12)
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
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
knee mouvement
Range of mouvement of the knee
Measured: preoperatively, on day 1 and day 7 postoperatively
walk
Numbers of steps
Measured: day 1 and day 2 postoperatively
Patient's satisfaction
3 level scale :0: not satisfied; 1: mild satisfaction; 2: satisfied
Measured: 48 hours postoperatively
Blood glucose level
Blood glucose level
Measured: 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]
Measured: 7 days postoperatively
quality of recovery
QoR15 score [ 136-150 excellent recovery - 0-89 poor recovery]
Measured: day one
neuropathic Chronic pain
DN4 questionnaire [ no neuropathic pain 0 - neuropathic pain >4]
Measured: 6 MONTHS
chronic pain
NRS on mouvement [ NRS =0 no pain ; NRS =10 worse pain]
Measured: 6 months
postoperative quality of life
SF-12 score [0 to 100, with higher scores indicating better physical and mental health functioning]
Measured: 6 months
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.
- First posted12 Oct 2023
- Study start15 Dec 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Olfa kaabachi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olfa kaabachi, MD, University Tunis El Manar
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Dexamethasone in the Adductor Canal Block for Postoperative Pain in Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT06079047
- Acronym / sponsor ID
- CE-IMKO- 111/2023
- Conditions
- Post Operative Pain
- Keywords
- knee arthroplasty, glucocorticoids, adductor canal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Olfa kaabachi, MDUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group Dexamethasone | Experimental | Procedure: group Dexamethasoneadductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of "dexamethasone" (8 mg) |
| group Controle | Active comparator | Procedure: group Controleadductor canal block with 10 ml of 0.5% "bupivacaine" + 10 ml of 0.9% saline solution + 2 ml of 0.9% saline solution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for unilateral TKA
- Surgery under spinal anesthesia
- ASA class I, II, and III patients
Key exclusion criteria (9 listed)
- Patient refusal to participate in the study
- Contraindication to regional anesthesia
- Allergies to the products used
- Bilateral TKA
- Revision TKA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group DexamethasoneAdductor canal block with dexamethasone | Procedure or surgery | group Dexamethasone |
| group ControleAdductor canal block with saline solution | Procedure or surgery | group Controle |
Primary outcome
morphine consumption
Time frame: 48 hours
postoperative consumption of morphine
12 secondary outcomes
NRS at rest
Time frame: 1 hour, 3 hours, 6 hours, 9 hours,12 hours, 24 hours, 36 hours and 48 hours postoperatively
NRS on mouvement
Time frame: 1 hour, 3 hous, 6 hours, 9 hours,12 hours, 24 hours, 36 houes and 48 hours postoperatively
knee mouvement
Time frame: preoperatively, on day 1 and day 7 postoperatively
walk
Time frame: day 1 and day 2 postoperatively
Patient's satisfaction
Time frame: 48 hours postoperatively
Blood glucose level
Time frame: 1 hour, 6 hours,12 hours,18 hours, 24 hours postoperatively
pain at home
Time frame: 7 days postoperatively
quality of recovery
Time frame: day one
neuropathic Chronic pain
Time frame: 6 MONTHS
chronic pain
Time frame: 6 months
postoperative quality of life
Time frame: 6 months
knee fonction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.