Dexamethasone Efficacy as an Adjuvant in Supraclavicular BlockPhase 2NCT04345588
Dexamethasone as an Adjuvant in Supraclavicular Block
A Phase 2 study testing Dexamethasone injection in people with Dexamethasone Efficacy as an Adjuvant in Supraclavicular Block, run by Assiut University.
Trial summary
The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dexamethasone Efficacy as an Adjuvant in Supraclavicular Block
- What is being tested?
- Dexamethasone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jun 2022
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients between 18 and 60 years of age 2. Both male and female gender 3. ASA physical status Classes I and II patients 4. Patients posted for upper limb surgery below shoulder.
Who cannot join
- 1. Patient refusal 2. Patients with bleeding disorders and those on anticoagulant therapy 3. History of allergy to local anesthetics 4. Infection at the site of block 5. Neuro deficit involving brachial plexus 6. Pregnant women 7. Patients with psychiatric behavior 8. ASA physical status Classes III and IV patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Analgesic Efficacy of Dexamethasone as an Adjuvant in Supraclavicular Block With Intravenous Dexamethasone After Supraclavicular Block in Patients Undergoing Forearm Surgeries
The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia .
Read the detailed description
Acute postoperative pain can be effectively controlled with the use of peripheral nerve blocks. Use of additives further prolongs the duration of analgesia For upper limb surgeries below shoulder joint, the brachial plexus block using supraclavicular approach introduced by Kulenkampff has gained popularity. Supraclavicular approach to brachial plexus block is useful for procedures done at or below the level of elbow.
This technique involves the deposition of local anesthetic near the brachial plexus approached from immediately above the clavicle. Brachial plexus is formed by ventral rami of C5, C6, C7, C8, and T1 which forms the roots.These then continue distally to form trunks, divisions, cords,and branches Local anesthetics used alone in supraclavicular block provide analgesia for 4-8 h.
The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia. Intravenous dexamethasone is also useful in attenuating the postoperative need for analgesics in different clinical settings even in the absence of any nerve blocks.
Hence, it is logical to compare the duration of analgesia with the use of dexamethasone in the setting of supraclavicular brachial plexus block, dexamethasone given either perineurally or intravenously.
- Being tested
- Dexamethasone injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone injectionDrug
we use injection lignocaine 10 mL, injection bupivacaine 0.5% 20 mL, 5 mL normal saline (NS). In group , injection dexamethasone 0.05 mg/kg will be added to the solution along with IV NS 1cc while the other group will receive 0.05 mg/kg injection dexamethasone intravenously.
| Study group | Role | What they receive |
|---|---|---|
| group received dexamethasone perineural | Active comparator | injection dexamethasone 0.05 mg/kg perineural. Receives: Drug: Dexamethasone injection |
| group received dexamethasone intravenous | Active comparator | injection dexamethasone 0.05 mg/kg intravenously. Receives: Drug: Dexamethasone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexamethasone efficacy as an Adjuvant in Supraclavicular Block
we will assess the efficacy of dexamethasone in supraclavicular anaethesia in terms of duration of analgesia and onset of motor and sensory block.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dexamethasone Efficacy as an Adjuvant in Supraclavicular BlockStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A convenience sample of 60 male and female adult patients will be taken, the patients will be classified into two equal groups , In all patients, we use injection lignocaine 10 mL, injection bupivacaine 0.5% 20 mL, 5 mL normal saline (NS). In one group , injection dexamethasone 0.05 mg/kg will be added to the solution along with IV NS 1cc while the other group will receive 0.05 mg/kg injection dexamethasone intravenously. Duration of analgesia, onset of sensory block, and onset of motor block will be studied.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohamed Abdel Hamid Ali, Assiut University
- Investigators
- Islam Mohamed Abdel Hamid, post graduated, Principal investigatorGolinar Mohamed Fathy, professor, Study directorAhmed Mohamed Abdel Moteleb, lecturer, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345588
- Sponsor's protocol ID
- Dexamethasone as an Adjuvant
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
PubMed 21956081Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
PubMed 19282714Lalla RK, Anant S, Nanda HS. Verapamil as an Adjunct to Local Anaesthetic for Brachial Plexus Blocks. Med J Armed Forces India. 2010 Jan;66(1):22-4. doi: 10.1016/S0377-1237(10)80086-3. Epub 2011 Jul 21.
PubMed 27365698Clerc S, Vuilleumier H, Frascarolo P, Spahn DR, Gardaz JP. Is the effect of inguinal field block with 0.5% bupivacaine on postoperative pain after hernia repair enhanced by addition of ketorolac or S(+) ketamine? Clin J Pain. 2005 Jan-Feb;21(1):101-5. doi: 10.1097/00002508-200501000-00012.
PubMed 15599137Jarbo K, Batra YK, Panda NB. Brachial plexus block with midazolam and bupivacaine improves analgesia. Can J Anaesth. 2005 Oct;52(8):822-6. doi: 10.1007/BF03021776.
PubMed 16189333Hargreaves KM, Costello A. Glucocorticoids suppress levels of immunoreactive bradykinin in inflamed tissue as evaluated by microdialysis probes. Clin Pharmacol Ther. 1990 Aug;48(2):168-78. doi: 10.1038/clpt.1990.132.
PubMed 2379387Hong JY, Han SW, Kim WO, Kim EJ, Kil HK. Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy. Br J Anaesth. 2010 Oct;105(4):506-10. doi: 10.1093/bja/aeq187. Epub 2010 Jul 20.
PubMed 20659915Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a.
PubMed 16368840De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PubMed 21799397
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Dexamethasone as an Adjuvant in Supraclavicular Block With Intravenous Dexamethasone After Supraclavicular Block in Patients Undergoing Forearm Surgeries
- ClinicalTrials.gov ID
- NCT04345588
- Acronym / sponsor ID
- Dexamethasone as an Adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 14 Apr 2020 (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.
The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia .
Detailed description
Acute postoperative pain can be effectively controlled with the use of peripheral nerve blocks. Use of additives further prolongs the duration of analgesia For upper limb surgeries below shoulder joint, the brachial plexus block using supraclavicular approach introduced by Kulenkampff has gained popularity. Supraclavicular approach to brachial plexus block is useful for procedures done at or below the level of elbow.
This technique involves the deposition of local anesthetic near the brachial plexus approached from immediately above the clavicle. Brachial plexus is formed by ventral rami of C5, C6, C7, C8, and T1 which forms the roots.These then continue distally to form trunks, divisions, cords,and branches Local anesthetics used alone in supraclavicular block provide analgesia for 4-8 h.
The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia. Intravenous dexamethasone is also useful in attenuating the postoperative need for analgesics in different clinical settings even in the absence of any nerve blocks.
Hence, it is logical to compare the duration of analgesia with the use of dexamethasone in the setting of supraclavicular brachial plexus block, dexamethasone given either perineurally or intravenously.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A convenience sample of 60 male and female adult patients will be taken, the patients will be classified into two equal groups , In all patients, we use injection lignocaine 10 mL, injection bupivacaine 0.5% 20 mL, 5 mL normal saline (NS). In one group , injection dexamethasone 0.05 mg/kg will be added to the solution along with IV NS 1cc while the other group will receive 0.05 mg/kg injection dexamethasone intravenously. Duration of analgesia, onset of sensory block, and onset of motor block will be studied.
| Arm | Type | Receives |
|---|---|---|
| group received dexamethasone perineural | Active comparator | Drug: Dexamethasone injectioninjection dexamethasone 0.05 mg/kg perineural. |
| group received dexamethasone intravenous | Active comparator | Drug: Dexamethasone injectioninjection dexamethasone 0.05 mg/kg intravenously. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Patients between 18 and 60 years of age 2. Both male and female gender 3. ASA physical status Classes I and II patients 4. Patients posted for upper limb surgery below shoulder.
Key exclusion criteria (1 listed)
- 1. Patient refusal 2. Patients with bleeding disorders and those on anticoagulant therapy 3. History of allergy to local anesthetics 4. Infection at the site of block 5. Neuro deficit involving brachial plexus 6. Pregnant women 7. Patients with psychiatric behavior 8. ASA physical status Classes III and IV patients
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 |
|---|---|---|
| Dexamethasone injectionwe use injection lignocaine 10 mL, injection bupivacaine 0.5% 20 mL, 5 mL normal saline (NS). In group , injection dexamethasone 0.05 mg/kg will be added to the solution along with IV NS 1cc while the other group will receive 0.05 mg/kg injection dexamethasone intravenously. | Drug | group received dexamethasone intravenous, group received dexamethasone perineural |
Primary outcome
Dexamethasone efficacy as an Adjuvant in Supraclavicular Block
Time frame: 2 years
we will assess the efficacy of dexamethasone in supraclavicular anaethesia in terms of duration of analgesia and onset of motor and sensory block.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 21956081Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
- Background: PubMed 19282714Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
- Background: PubMed 27365698Lalla RK, Anant S, Nanda HS. Verapamil as an Adjunct to Local Anaesthetic for Brachial Plexus Blocks. Med J Armed Forces India. 2010 Jan;66(1):22-4. doi: 10.1016/S0377-1237(10)80086-3. Epub 2011 Jul 21.
- Background: PubMed 15599137Clerc S, Vuilleumier H, Frascarolo P, Spahn DR, Gardaz JP. Is the effect of inguinal field block with 0.5% bupivacaine on postoperative pain after hernia repair enhanced by addition of ketorolac or S(+) ketamine? Clin J Pain. 2005 Jan-Feb;21(1):101-5. doi: 10.1097/00002508-200501000-00012.
- Background: PubMed 16189333Jarbo K, Batra YK, Panda NB. Brachial plexus block with midazolam and bupivacaine improves analgesia. Can J Anaesth. 2005 Oct;52(8):822-6. doi: 10.1007/BF03021776.
- Background: PubMed 2379387Hargreaves KM, Costello A. Glucocorticoids suppress levels of immunoreactive bradykinin in inflamed tissue as evaluated by microdialysis probes. Clin Pharmacol Ther. 1990 Aug;48(2):168-78. doi: 10.1038/clpt.1990.132.
- Background: PubMed 20659915Hong JY, Han SW, Kim WO, Kim EJ, Kil HK. Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy. Br J Anaesth. 2010 Oct;105(4):506-10. doi: 10.1093/bja/aeq187. Epub 2010 Jul 20.
- Background: PubMed 16368840Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a.
- Background: PubMed 21799397De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
- Iohom G, Machmachi A, Diarra DP, Khatouf M, Boileau S, Dap F, et al.The effects of clonidine added to mepivacaine for paronychia surgery under axillary brachial plexus block. Anesth Analg 2005;100:1179-83.Link provided by the sponsor.
- Comparative Study of Effectiveness of Tramadol and Butorphanol as Adjuvants to Levobupivacaine for Supraclavicular Brachial Plexus Block.Link provided by the sponsor.
- Kulenkampff D. Anesthesia of the brachial plexus. Zentralbl Chir 1911;38:1337-40.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Islam Mohamed Abdel Hamid, post graduated principal investigator
Golinar Mohamed Fathy, professor study director
Ahmed Mohamed Abdel Moteleb, lecturer study director
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone injection in people with Dexamethasone Efficacy as an Adjuvant in Supraclavicular Block, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Islam Mohamed Abdel Hamid, post graduated (01142191441, drislamelmelegy110@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexamethasone efficacy as an Adjuvant in Supraclavicular Block (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345588, which also lists 9 linked publications.
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 14 Apr 2020.