The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block

NCT04554862 | Completed Phase 4

• 1 other identifier: M419
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Despite many regional anesthetic techniques have been described for anesthesia of the brachial plexus which is responsible for the sensory and motor innervation of entire upper limb, still, supraclavicular block (SCB) is the regional anesthetic technique of choice. SCB has been described as the spinal anesthesia of the upper limb as it offers dense anesthesia of the brachial plexus for the surgical procedures below the arm from elbow to hand. Although the SCB has a high incidence of complications like pneumothorax, the use of ultrasound-guided block improved the safety for the patient. There are several adjuvants have been added to SCB aiming for prolongation of the duration of peripheral nerve block as fentanyl, alpha 2 adrenergic agonist (Dexmedetomidine, Clonidine), tramadol, ketorolac and Magnesium sulfate. Magnesium has anti-nociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli. Non-Steroidal Anti-Inflammatory drugs (NSAID) inhibit synthesis of prostaglandins from arachnoid acid in phospholipid membranes resulting in decreased afferent nociceptive signals from the site of surgery. There are a lot of studies supported the analgesic effect when NSAIDs are concentrated at a peripheral site compared to the systemic administration therapy. Ketorolac is a parenteral NSAIDs. Studies have shown that ketorolac as an adjuvant to local anesthetics during peripheral nerve block enhanced duration and quality of analgesia.

Conditions

Postoperative Pain

Keywords

Magnesium; Ketorolac; Supraclavicular block

Outcome Measures

Primary Outcomes (1)

• the cumulative morphine consumption

  In milligrams

  At 24 hours postoperative

Secondary Outcomes (17)

• numerical rating scale (NRS) of postoperative pain

  at 1 hour in the post-anesthesia care unit (PACU)

• numerical rating scale (NRS) of postoperative pain

  at 4 hours postoperative

• numerical rating scale (NRS) of postoperative pain

  at 8 hours postoperative

• numerical rating scale (NRS) of postoperative pain

  at 12 hours postoperative

• numerical rating scale (NRS) of postoperative pain

  at 24 hours postoperative

Study Arms (2)

the intervention group (M) magnesium sulfate

ACTIVE COMPARATOR

a 6ml of magnesium sulfate 10% (600mg) will be added to 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block

Drug: Magnesium sulfate; Procedure: supraclavicular block

the intervention group (K) ketorolac

ACTIVE COMPARATOR

a 2ml of ketorolac (30mg) will be added to 4ml of normal saline and 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block

Drug: Ketorolac Tromethamine; Procedure: supraclavicular block

Interventions

Magnesium sulfate DRUG

magnesium sulfate will be added to the block

Also known as: magnesium 10%

the intervention group (M) magnesium sulfate

Ketorolac Tromethamine DRUG

ketorolac will be added to the block

Also known as: ketorolac

the intervention group (K) ketorolac

supraclavicular block PROCEDURE

it is done by ultrasound- guided

the intervention group (K) ketorolac; the intervention group (M) magnesium sulfate

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status from I to III participants who were scheduled for surgical procedures of the arm from elbow to hand

You may not qualify if:

• Patient refusal.
• Contraindication to regional anesthesia (coagulopathy, allergy to the local anesthetic or any adjuvants added, severe thrombocytopenia, pre-existing neuropathy in the operative limb, infection at puncture site).
• Sepsis.
• Pregnant or lactating women.
• Hepatic or renal dysfunction.
• Any drug or opioid abuse.
• Surgical procedures for more than 3h.
• Advanced cardiac diseases.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (5)

• Mukherjee K, Das A, Basunia SR, Dutta S, Mandal P, Mukherjee A. Evaluation of Magnesium as an adjuvant in Ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded randomized controlled study. J Res Pharm Pract. 2014 Oct;3(4):123-9. doi: 10.4103/2279-042X.145387.

  PMID: 25535620 BACKGROUND

• Mirkheshti A, Saadatniaki A, Salimi A, Manafi Rasi A, Memary E, Yahyaei H. Effects of dexmedetomidine versus ketorolac as local anesthetic adjuvants on the onset and duration of infraclavicular brachial plexus block. Anesth Pain Med. 2014 Aug 2;4(3):e17620. doi: 10.5812/aapm.17620. eCollection 2014 Aug.

  PMID: 25237638 BACKGROUND

• Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.

  PMID: 22012543 BACKGROUND

• Reinhart DJ, Stagg KS, Walker KG, Wang WP, Parker CM, Jackson HH, Walker EB. Postoperative analgesia after peripheral nerve block for podiatric surgery: clinical efficacy and chemical stability of lidocaine alone versus lidocaine plus ketorolac. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):506-13. doi: 10.1053/rapm.2000.7624.

  PMID: 11009237 BACKGROUND

• Akhondzade R, Nesioonpour S, Gousheh M, Soltani F, Davarimoghadam M. The Effect of Magnesium Sulfate on Postoperative Pain in Upper Limb Surgeries by Supraclavicular Block Under Ultrasound Guidance. Anesth Pain Med. 2017 Jun 10;7(3):e14232. doi: 10.5812/aapm.14232. eCollection 2017 Jun.

  PMID: 28924560 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate; Ketorolac Tromethamine; Ketorolac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Safaa G Ragab, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 18, 2020
• Study Start: October 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

EG (1)