RegionalNCT07074691
Regional and Intravenous Dexamethasone in The Prophylaxis of Rebound Pain After Supraclavicular Block in Upper Limb Surgeries
A study testing Regional Dexamethasone and Intravenous Dexamethasone in people with Regional and Intravenous, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the effect of regional and intravenous Dexamethasone in the prophylaxis of rebound pain after supraclavicular block in upper limb surgeries. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Regional, Intravenous, Dexamethasone
- What is being tested?
- Regional Dexamethasone and Intravenous Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Feb 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) class I-II.
- Undergoing upper limb surgeries.
Who cannot join
- Patient refusal.
- History of allergy to drugs used.
- ASA class more than II ( III-IV-..).
- Uncooperative patient.
- Patients on chronic pain medications.
- Coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Regional and Intravenous Dexamethasone in The Prophylaxis of Rebound Pain After Supraclavicular Block in Upper Limb Surgeries: A Double-Blinded Study
This study aimed to compare the effect of regional and intravenous Dexamethasone in the prophylaxis of rebound pain after supraclavicular block in upper limb surgeries.
Read the detailed description
Rebound pain is defined as "a transient acute increase in postoperative pain which occurs following resolution of a peripheral nerve block (PNB)" or as a phenomenon where a quantifiable difference is seen in the pain scores when the PNB is working compared to when its effect is resolved.
The supraclavicular block is a regional anesthetic technique used as an alternative or adjunct to general anesthesia or used for postoperative pain control for upper extremity surgeries (mid-humerus through the hand).
Dexamethasone, an adjunct used to prolong the duration of neural blockade when administered regionally or systemically, is thought to reduce pain sensitization by inhibiting sensory transmission of nociceptive C-fibers at the dorsal root ganglion and reducing prostaglandin synthesis, thereby suppressing hyperalgesia.
- Conditions
- Regional, Intravenous, Dexamethasone, Prophylaxis, Rebound Pain, Supraclavicular Block
- Being tested
- Regional Dexamethasone, Intravenous Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional DexamethasoneDrug
Patients were generally anesthetized, then a supraclavicular block is given (0.5% bupivacaine + dexamethasone 8 mg regionally), total volume = 20 mL (18 mL 0.5% bupivacaine + 2 mL dexamethasone).
Intravenous DexamethasoneDrug
Patients were generally anesthetized, and then a supraclavicular block was administered (0.5% bupivacaine), with a total volume of 20 mL (18 mL of 0.5% bupivacaine and 2 mL of normal saline).
| Study group | Role | What they receive |
|---|---|---|
| Regional Dexamethasone group | Experimental | Patients were generally anesthetized, then a supraclavicular block is given (0.5% bupivacaine + dexamethasone 8 mg regionally), total volume = 20 mL (18 mL 0.5% bupivacaine + 2 mL dexamethasone). Receives: Drug: Regional Dexamethasone |
| Intravenous Dexamethasone group | Experimental | Patients were generally anesthetized, and then a supraclavicular block was administered (0.5% bupivacaine), with a total volume of 20 mL (18 mL of 0.5% bupivacaine and 2 mL of normal saline). Receives: Drug: Intravenous Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first request of analgesia
Time to the first request of analgesia was recorded from the end of surgery till the first dose of pethidine administrated.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Degree of pain
All patients were familiarized with the Numeric Rating Scale (NRS) from 0 to 10, with 0 representing no pain and 10 representing maximum intolerable pain. NRS score will be assessed and recorded at 30 minutes, 2, 6, 12, 18, 24 hours postoperatively.
Measured: 24 hours postoperatively
Patient Satisfaction
Postoperative Patient Satisfaction measured in " 4 scale patient satisfaction score" ( 1 = highly satisfied , 2 = fairly satisfied , 3 = little satisfied , 4 = non satisfied ).
Measured: 24 hours postoperatively
Total Analgesics consumption
Pethidine 50 mg intravenous was given as postoperative rescue analgesia when the Numeric Rating Scale (NRS) score was≥ 4.
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as nausea, vomiting, hypotension and bradycardia were recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Mar 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RegionalStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal AbdElNaby Ramadan Hamada, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074691
- Sponsor's protocol ID
- 36264MS507/2/24
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Regional and Intravenous Dexamethasone in The Prophylaxis of Rebound Pain After Supraclavicular Block in Upper Limb Surgeries: A Double-Blinded Study
- ClinicalTrials.gov ID
- NCT07074691
- Acronym / sponsor ID
- 36264MS507/2/24
- Conditions
- Regional, Intravenous, Dexamethasone, Prophylaxis, Rebound Pain, Supraclavicular Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 20 Jul 2025 (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 study aimed to compare the effect of regional and intravenous Dexamethasone in the prophylaxis of rebound pain after supraclavicular block in upper limb surgeries.
Detailed description
Rebound pain is defined as "a transient acute increase in postoperative pain which occurs following resolution of a peripheral nerve block (PNB)" or as a phenomenon where a quantifiable difference is seen in the pain scores when the PNB is working compared to when its effect is resolved.
The supraclavicular block is a regional anesthetic technique used as an alternative or adjunct to general anesthesia or used for postoperative pain control for upper extremity surgeries (mid-humerus through the hand).
Dexamethasone, an adjunct used to prolong the duration of neural blockade when administered regionally or systemically, is thought to reduce pain sensitization by inhibiting sensory transmission of nociceptive C-fibers at the dorsal root ganglion and reducing prostaglandin synthesis, thereby suppressing hyperalgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Dexamethasone group | Experimental | Drug: Regional DexamethasonePatients were generally anesthetized, then a supraclavicular block is given (0.5% bupivacaine + dexamethasone 8 mg regionally), total volume = 20 mL (18 mL 0.5% bupivacaine + 2 mL dexamethasone). |
| Intravenous Dexamethasone group | Experimental | Drug: Intravenous DexamethasonePatients were generally anesthetized, and then a supraclavicular block was administered (0.5% bupivacaine), with a total volume of 20 mL (18 mL of 0.5% bupivacaine and 2 mL of normal saline). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) class I-II.
- Undergoing upper limb surgeries.
Key exclusion criteria (6 listed)
- Patient refusal.
- History of allergy to drugs used.
- ASA class more than II ( III-IV-..).
- Uncooperative patient.
- Patients on chronic pain medications.
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 |
|---|---|---|
| Regional DexamethasonePatients were generally anesthetized, then a supraclavicular block is given (0.5% bupivacaine + dexamethasone 8 mg regionally), total volume = 20 mL (18 mL 0.5% bupivacaine + 2 mL dexamethasone). | Drug | Regional Dexamethasone group |
| Intravenous DexamethasonePatients were generally anesthetized, and then a supraclavicular block was administered (0.5% bupivacaine), with a total volume of 20 mL (18 mL of 0.5% bupivacaine and 2 mL of normal saline). | Drug | Intravenous Dexamethasone group |
Primary outcome
Time to the first request of analgesia
Time frame: 24 hours postoperatively
Time to the first request of analgesia was recorded from the end of surgery till the first dose of pethidine administrated.
4 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Patient Satisfaction
Time frame: 24 hours postoperatively
Total Analgesics consumption
Time frame: 24 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
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 20 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Regional Dexamethasone and Intravenous Dexamethasone in people with Regional and Intravenous, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 6 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 20 Jul 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 Egypt. 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?
Time to the first request of analgesia (time frame: 24 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 20 Jul 2025.