Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block

NCT ID: NCT04000100

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2019-01-15

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

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

ultrasound- guided supraclavicular brachial plexus block

Intervention Type: 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

Neostigmine group

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

Group Type: ACTIVE_COMPARATOR

ultrasound- guided supraclavicular brachial plexus block

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ABEER HASSANIN

OTHER

Sponsor Role: lead

Responsible Party

ABEER HASSANIN

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ebrahim Abbas, MD

Role: STUDY_DIRECTOR

faculty of medicine

Locations

Minya university hospital

Minya, , Egypt

Countries

Egypt

Other Identifiers

72-7-2018

Identifier Type: -

Identifier Source: org_study_id