Dexamethasone as an Adjuvant in Supraclavicular Block

NCT04345588 | Unknown Phase 2

• 1 other identifier: Dexamethasone as an Adjuvant
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia .

Conditions

Dexamethasone Efficacy as an Adjuvant in Supraclavicular Block

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

group received dexamethasone perineural

ACTIVE COMPARATOR

injection dexamethasone 0.05 mg/kg perineural.

Drug: Dexamethasone injection

group received dexamethasone intravenous

ACTIVE COMPARATOR

injection dexamethasone 0.05 mg/kg intravenously.

Drug: Dexamethasone injection

Interventions

Dexamethasone injection DRUG

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.

group received dexamethasone intravenous; group received dexamethasone perineural

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 21956081 BACKGROUND

• Neal 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.

  PMID: 19282714 BACKGROUND

• Lalla 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.

  PMID: 27365698 BACKGROUND

• Clerc 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.

  PMID: 15599137 BACKGROUND

• Jarbo 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.

  PMID: 16189333 BACKGROUND

• Hargreaves 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.

  PMID: 2379387 BACKGROUND

• Hong 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.

  PMID: 20659915 BACKGROUND

• Movafegh 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.

  PMID: 16368840 BACKGROUND

• De 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.

  PMID: 21799397 BACKGROUND

Related Links

• 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.
• Comparative Study of Effectiveness of Tramadol and Butorphanol as Adjuvants to Levobupivacaine for Supraclavicular Brachial Plexus Block.
• Kulenkampff D. Anesthesia of the brachial plexus. Zentralbl Chir 1911;38:1337-40.

MeSH Terms

Interventions

Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Islam Mohamed Abdel Hamid, post graduated

  PRINCIPAL INVESTIGATOR

• Golinar Mohamed Fathy, professor

  STUDY DIRECTOR

• Ahmed Mohamed Abdel Moteleb, lecturer

  STUDY DIRECTOR

Central Study Contacts

Islam Mohamed Abdel Hamid, post graduated

CONTACT

01142191441; drislamelmelegy110@gmail.com

Ahmed Mohamed Abdel Moteleb, lecturer

CONTACT

01003167713; Ahmedteleb12283@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share