Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block

Effect OF Adding Neostigmine to Bupivacaine for Ultrasound Guided Supraclavicular Brachial Plexus Block in Forearm Surgeries

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: ultrasound- guided supraclavicular brachial plexus block

Detailed Description

All patients were assessed with regards to:

Hemodynamics (heart rate, Bp) and oxygen saturation were recorded preoperatively just before the block as a baseline value, immediately after the block 5, 20, 30,40,45 , 60 minutes during the operative time and 1, 2, 4, 6, 9 and 12 hours after end of operation.

Onset time of sensory block, Onset time of motor block, Duration of sensory block, and Duration of motor block.

Pain assessment using a scoring system based on the visual analogue pain scale(VAS) measured at the following time intervals 0, 2, 4, 6, 9, 12 and 24 post operatively, time to first analgesic requirement (in hours) and total analgesic consumption was monitored in the two groups for 24 hours in ward.

The incidence of adverse effects whether related to the drugs used in the technique or related to the technique itself were recorded.

The results of this study found that demographic (age, sex, weight and ASA classification and surgical duration were statistically insignificant between the two groups.

Hemodynamics (HR and Bp) were statistically significant between the groups .They were lower in Neostigmine groups.

As regard onset of sensory and motor block were clinically and significantly earlier in group B than group A ( p < 0,05) and the same for duration of sensory and motor block were clinically and significantly longer in group B than in group A ( P < 0,05 ). Regarding Visual Analogue Pain Scale (VAS), while comparing the two groups, the differences were significant at 9 and 12 hours after surgery for the favor of the neostigmine groups . The time to first analgesic request was significantly longer in group B than group A.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 611111
    • Minya university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; This group received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline	Procedure: ultrasound- guided supraclavicular brachial plexus block; 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
Active Comparator: Neostigmine group; This group received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg)	Procedure: ultrasound- guided supraclavicular brachial plexus block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia (first request for analgesic)	The time from local anesthetic administration to the patient's first request for analgesic medication by hours	Every 30 minutes for 4 hours then every 2 hours for 24 hours
Visual analogue pain score	Pain intensity was assessed using Visual analogue pain score. The Visual analogue pain score is consisted of a straight ,vertical 10-cm line; the bottom point represented "no pain"=(0 cm) and the top "the worst pain you could ever have =(10 cm)	2,4,6,8,12,16,20 and 24 hours postoperative

Collaborators and Investigators

• Sponsor: ABEER HASSANIN
• Investigators: Study Director: Ebrahim Abbas, MD, Faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Bupivacaine; Neostigmine; Supraclavicular brachial plexus block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 72-7-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all data can be shared
• IPD Sharing Time Frame: From now
• IPD Sharing Access Criteria: abeerhassanin@yahoo.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No