PainNCT07313553
Prevention of Rebound Pain After Axillary Block
A study testing Saline and Dexamathsone 4mg/ml associated with experimental arm in people with Pain and Postoperative Care, run by University Tunis El Manar.
Trial summary
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative Care
- What is being tested?
- Saline and Dexamathsone 4mg/ml associated with experimental arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age between 18 and 75 years old.
- Patients are current for hand surgery under axillary plexus block.
- Patients classified ASA physical status I, II and III
Who cannot join
- - Contraindication to regional anesthesia.
- Patient's disapproval.
- Impaired cognition.
- Patients whose surgery must be done under general anesthesia (complex hand surgery or association of other)
- Allergy to paracetamol, dexamethasone or opioids
About this study
Official title: The Effect of Perineural Dexamethasone on Preventing Rebound Pain After Axillary Plexus Block in Hand Surgery
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.
Read the detailed description
After the arrival to the operation room, monitoring including pulse oximetry, electrocardiogram, and noninvasive blood pressure was applied.
An 18 or 16-gauge IV cannula was inserted and Ringer's lactate infusion was started at a rate of 5 mL per kg per hour.
Antibioprophylaxis was systematically administered with 2 grams ofCefazolin 30 minutes before induction.
All patients were given an ultrasound-guided single-injection axillary plexus block by experienced anesthesiologists.
Sedation with 2 mg midazolam intravenously before block was administered.
In the group Dexamethasone (D), patients received axillary plexus block with a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
In the group control (X), patients received a 30 mlof a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% containing 2 ml saline solution.
For the axillary plexus block, patients were placed in a supine positionwith the arm in 90° of abduction and the forearm in flexion.A high frequency linear probe was placed on the transverse axis, over the axillary fold.The axillary artery, vein, and nerves surrounding the artery were visualized after scanning distally and proximally. The block needle (50 mm, 22G) was inserted in-plane from anterior to posterior, parallel to the ultrasound probe.It was advanced toward the musculocutaneous nerve (MCN) and local anesthetic was injected.Then, the needle was retracted and redirected deep relative to the axillary artery and local anesthetic was injectedaround the posterior aspect of the axillary artery and finallythe needle was retracted and redirected superficial to the axillary artery and local anesthetic was injected.
Before the surgical incision, the effectiveness of the sensory blockade of the axillary plexus was evaluated by a cold test in the different territories.
Post-operatively, all patients were put on systematic paracetamol 1 g every 6 hours, without exceeding 4 grams per day.
when the postoperative pain score (NRS) was >3/10, intravenous tramadol 100 mg was administered.
- Conditions
- Pain, Postoperative Care
- Being tested
- Saline, Dexamathsone 4mg/ml associated with experimental arm
- Keywords
- axillary nerve block, dexamethesone, rebound pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
2 ml saline solution are added to 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%
Dexamathsone 4mg/ml associated with experimental armDrug
Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Axillary Plexus Block with dexametasone | Active comparator | In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone. Receives: Drug: Dexamathsone 4mg/ml associated with experimental arm |
| Axillary Plexus Block control | Placebo comparator | In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 2 mL of saline solution. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Rebound pain
The primary objective is the incidence of rebound pain, which was defined as severe pain (NRS ≥ 7) [Numerical rate scale from 0 no pain to 10 worst pain] at the surgical site during the first 48 hours postoperatively.
Measured: 1 hour postoperatively to 48 hours postoperatively
Secondary outcomes (5)
Pain score at rest
Pain score at rest using NRS [Numerical Rate Scale from 0 no pain to 10 worst pain
Measured: hour 1, hour 48 postoperative
Pain score at movement
Pain scores at mouvement using NRS [Numerical Rate Scale from 0 no pain to 10 worst pain
Measured: hour 1, hour 48 postoperative
The analgesic consumption
The number of rescue analgesic dose during the first 24 hours
Measured: hour 1, hour 24 postoperatively
Duration of motor block
The end of motor block was defined by a total flexion of fingers and arm.
Measured: hour 1 postoperatively, 12 hours after nerve block
Blood glucose level
level of glucose in serum blood
Measured: after nerve block, 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start12 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfa kaabachi, MD, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313553
- Sponsor's protocol ID
- IMKO-CE-2023-004
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perineural Dexamethasone on Preventing Rebound Pain After Axillary Plexus Block in Hand Surgery
- ClinicalTrials.gov ID
- NCT07313553
- Acronym / sponsor ID
- IMKO-CE-2023-004
- Conditions
- Pain, Postoperative Care
- Keywords
- axillary nerve block, dexamethesone, rebound pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 12 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Jan 2026 (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.
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.
Detailed description
After the arrival to the operation room, monitoring including pulse oximetry, electrocardiogram, and noninvasive blood pressure was applied.
An 18 or 16-gauge IV cannula was inserted and Ringer's lactate infusion was started at a rate of 5 mL per kg per hour.
Antibioprophylaxis was systematically administered with 2 grams ofCefazolin 30 minutes before induction.
All patients were given an ultrasound-guided single-injection axillary plexus block by experienced anesthesiologists.
Sedation with 2 mg midazolam intravenously before block was administered.
In the group Dexamethasone (D), patients received axillary plexus block with a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
In the group control (X), patients received a 30 mlof a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% containing 2 ml saline solution.
For the axillary plexus block, patients were placed in a supine positionwith the arm in 90° of abduction and the forearm in flexion.A high frequency linear probe was placed on the transverse axis, over the axillary fold.The axillary artery, vein, and nerves surrounding the artery were visualized after scanning distally and proximally. The block needle (50 mm, 22G) was inserted in-plane from anterior to posterior, parallel to the ultrasound probe.It was advanced toward the musculocutaneous nerve (MCN) and local anesthetic was injected.Then, the needle was retracted and redirected deep relative to the axillary artery and local anesthetic was injectedaround the posterior aspect of the axillary artery and finallythe needle was retracted and redirected superficial to the axillary artery and local anesthetic was injected.
Before the surgical incision, the effectiveness of the sensory blockade of the axillary plexus was evaluated by a cold test in the different territories.
Post-operatively, all patients were put on systematic paracetamol 1 g every 6 hours, without exceeding 4 grams per day.
when the postoperative pain score (NRS) was >3/10, intravenous tramadol 100 mg was administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary Plexus Block with dexametasone | Active comparator | Drug: Dexamathsone 4mg/ml associated with experimental armIn the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone. |
| Axillary Plexus Block control | Placebo comparator | Other: SalineIn the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 2 mL of saline solution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age between 18 and 75 years old.
Key exclusion criteria (5 listed)
- - Contraindication to regional anesthesia.
- Patient's disapproval.
- Impaired cognition.
- Patients whose surgery must be done under general anesthesia (complex hand surgery or association of other)
- Allergy to paracetamol, dexamethasone or opioids
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 |
|---|---|---|
| Saline2 ml saline solution are added to 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% | Other | Axillary Plexus Block control |
| Dexamathsone 4mg/ml associated with experimental armIntervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone. | Drug | Axillary Plexus Block with dexametasone |
Primary outcome
incidence of Rebound pain
Time frame: 1 hour postoperatively to 48 hours postoperatively
The primary objective is the incidence of rebound pain, which was defined as severe pain (NRS ≥ 7) [Numerical rate scale from 0 no pain to 10 worst pain] at the surgical site during the first 48 hours postoperatively.
5 secondary outcomes
Pain score at rest
Time frame: hour 1, hour 48 postoperative
Pain score at movement
Time frame: hour 1, hour 48 postoperative
The analgesic consumption
Time frame: hour 1, hour 24 postoperatively
Duration of motor block
Time frame: hour 1 postoperatively, 12 hours after nerve block
Blood glucose level
Time frame: after nerve block, 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Saline and Dexamathsone 4mg/ml associated with experimental arm in people with Pain and Postoperative Care, run by University Tunis El Manar.
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 5 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: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
incidence of Rebound pain (time frame: 1 hour postoperatively to 48 hours postoperatively). 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 2 Jan 2026.