Dexamethasone as an Adjuvant in Supraclavicular Block

NCT ID: NCT04345588

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Dexamethasone Efficacy as an Adjuvant in Supraclavicular Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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group received dexamethasone perineural

injection dexamethasone 0.05 mg/kg perineural.

Group Type ACTIVE_COMPARATOR

Dexamethasone injection

Intervention Type 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

injection dexamethasone 0.05 mg/kg intravenously.

Group Type ACTIVE_COMPARATOR

Dexamethasone injection

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Islam Mohamed Abdel Hamid Ali

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Islam Mohamed Abdel Hamid, post graduated

Role: PRINCIPAL_INVESTIGATOR

Golinar Mohamed Fathy, professor

Role: STUDY_DIRECTOR

Ahmed Mohamed Abdel Moteleb, lecturer

Role: STUDY_DIRECTOR

Central Contacts

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Islam Mohamed Abdel Hamid, post graduated

Role: CONTACT

01142191441

Ahmed Mohamed Abdel Moteleb, lecturer

Role: CONTACT

01003167713

References

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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.

Reference Type BACKGROUND
PMID: 21956081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19282714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27365698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15599137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16189333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2379387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20659915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16368840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21799397 (View on PubMed)

Related Links

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https://europepmc.org/article/med/15781541

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.

https://europepmc.org/article/PMC/6775833

Comparative Study of Effectiveness of Tramadol and Butorphanol as Adjuvants to Levobupivacaine for Supraclavicular Brachial Plexus Block.

https://www.ijss-sn.com/uploads/2/0/1/5/20153321/ijss_mar_oa07_-_2018.pdf

Kulenkampff D. Anesthesia of the brachial plexus. Zentralbl Chir 1911;38:1337-40.

Other Identifiers

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Dexamethasone as an Adjuvant

Identifier Type: -

Identifier Source: org_study_id

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