Verapamil in Supraclavicular Brachial Plexus Block

Not Applicable

• Conditions: Regional Anesthesia Morbidity
• Interventions: Diagnostic Test: complete blood count; Diagnostic Test: prothrombin time; Diagnostic Test: prothrombin concentration; Drug: Verapamil

• Registration Number: NCT05183997
• Lead Sponsor: Assiut University

Brief Summary

Supraclavicular brachial plexus block (SCBPB) is the common approach to provide surgical anesthesia of upper limb. The effects of single-injection brachial plexus nerve blocks recede after several hours unmasking the moderate to- severe pain of the surgical insult.

Detailed Description

Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, a2 agonists (i.e. clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone.

The investigators will use calcium channel blocker as adjuvant to bupivacaine in supraclavicular block. Calcium plays an important role in analgesia produced by local anesthetics. The activation of N-methyl-D-aspartate receptors may lead to calcium entry into cells and potentiation of spinal cord and plays a role in pain formation. Hence, calcium channel blockers may prevent central sensitization and provide better sensory motor block characteristics. Verapamil, a calcium channel blocker can potentiate analgesic action of local anesthetics and reduce postoperative pain and analgesic consumption. Few studies were there using 2.5 mg of verapamil, showing no effect on onset and duration of sensory motor block. Hence, the investigators have used 5 mg of verapamil as adjuvant to bupivacaine. The primary aim of the study was to know whether verapamil (5 mg) as adjuvant to bupivacaine in supraclavicular brachial plexus block would delay the need of rescue analgesia.

Study Timeline

• Study First Submitted: 2021-10-08
• Status Verified: 2022-01
• Study Start: 2022-01
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA I-II patients older than 18years and scheduled for forearm and hand surgeries like :

  1. fracture radius and ulna.
  2. cut wrists.

Exclusion Criteria

1. allergy to the study drugs,
2. skin infection at site of needle puncture,
3. significant organ dysfunction, coagulopathy, drug or alcohol abuse, epilepsy, and psychiatric illness that would interfere with perception and assessment of pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (A) : 30 patients (control group):	complete blood count	Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .
Group (A) : 30 patients (control group):	prothrombin time	Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .
Group (A) : 30 patients (control group):	prothrombin concentration	Patient will receive 20 to 30 ml bupivacaine plus 2 ml of normal saline .
Group (B) : 30 patients (verapamil group):	complete blood count	Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.
Group (B) : 30 patients (verapamil group):	prothrombin time	Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.
Group (B) : 30 patients (verapamil group):	prothrombin concentration	Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.
Group (B) : 30 patients (verapamil group):	Verapamil	Patient will receive 20 to 30 ml bupivacaine plus 5 mg of verapamil diluted in 2 ml of normal saline.

Primary Outcome Measures

Name	Time	Method
duration of postoperative analgesia.	in first 24 hours	blinded observer will collect the Visual Analogue Score (VAS) for pain scored from Zero to ten where 0= no pain and 10 = the worst pain imaginable for acute post-operative pain.