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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04345588
Other study ID # Dexamethasone as an Adjuvant
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date January 1, 2021
Est. completion date June 1, 2022

Study information

Verified date April 2020
Source Assiut University
Contact Islam Mohamed Abdel Hamid, post graduated
Phone 01142191441
Email drislamelmelegy110@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms

  • Dexamethasone Efficacy as an Adjuvant in Supraclavicular Block

Intervention

Drug:
Dexamethasone injection
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Jarbo K, Batra YK, Panda NB. Brachial plexus block with midazolam and bupivacaine improves analgesia. Can J Anaesth. 2005 Oct;52(8):822-6. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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