Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block

NCT04000100 | Completed

• 1 other identifier: 72-7-2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patients were randomly allocated into Two equal study groups each contain (40) patients : Patients in Group A received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline and patients in Group B received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg). The investigators found that neostigmine when used as an adjuvant to bupivacaine in ultrasound guided supraclavicular brachial plexus block has advantage over bupivacaine alone especially in the quality of sensory block and provide safe and effective post-operative analgesia in patients undergoing forearm surgeries

Conditions

Postoperative Pain

Keywords

Neostigmine; Bupivacaine; Supraclavicular brachial plexus block

Outcome Measures

Primary Outcomes (4)

• The onset of sensory blockade

  Onset time for sensory block was defined as the time interval between the end of local anesthetic administration untill complete sensory block by minutes

  Every 2 minutes for 30 minutes

• The onset of motor blockade

  Onset time for motor block was defined as the time interval between the end of local anesthetic administration until complete motor block by minutes

  Every 2 minutes for 30 minutes

• Duration of sensory blockade

  Duration of sensory block was defined as the time interval between the complete sensory block and complete resolution of anesthesia on all the nerves by hours

  Every 1 hour for 24 hours

• Duration of motor blockade

  the time interval from complete motor block to complete recovery of motor function of hand and forearm by hours

  Every 1 hour for 24 hours

Secondary Outcomes (2)

• Duration of analgesia (first request for analgesic)

  Every 30 minutes for 4 hours then every 2 hours for 24 hours

• Visual analogue pain score

  2,4,6,8,12,16,20 and 24 hours postoperative

Study Arms (2)

Control group

PLACEBO COMPARATOR

This group received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline

Procedure: ultrasound- guided supraclavicular brachial plexus block

Neostigmine group

ACTIVE COMPARATOR

This group received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg)

Procedure: ultrasound- guided supraclavicular brachial plexus block

Interventions

ultrasound- guided supraclavicular brachial plexus block PROCEDURE

Patient lie down supine with head turned 45 degrees to the contralateral side and ipsilateral arm adducted gently by the assistant and the shoulder kept down with flexed elbow. After sterile preparation of the skin and the ultrasound probe (12 MHz probe) were used, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the brachial plexus was seen at the supraclavicular region, it either appeared as 3 hypoechoic circles with hyperechoic outer rings or as a grape like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region figure

Control group; Neostigmine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA ( I-II)
• Age: from ≥18 years
• Sex: male or female
• type of operation : Forearm Orthopedic surgeries
• Type of anaesthesia : supraclavicular brachial plexus block
• Duration of operation : 60-90 min

You may not qualify if:

• Patient refusal for the procedure
• Any bleeding tendency
• Neurological deficits involving brachial plexus
• Patients with allergy to local anesthetics
• Local infection at the site of injection
• Patients on any sedatives or antipsychotics
• Body mass index \>35.

Sponsors & Collaborators

• ABEER HASSANIN: lead

Study Sites (1)

Minya university hospital

Minya, 611111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Ebrahim Abbas, MD

  faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 27, 2019
• Study Start: July 15, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From now
• Access Criteria: abeerhassanin@yahoo.com

Locations

EG (1)