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Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block

A

ABEER HASSANIN

Status

Completed

Conditions

Postoperative Pain

Treatments

Procedure: ultrasound- guided supraclavicular brachial plexus block

Study type

Interventional

Funder types

Other

Identifiers

NCT04000100
72-7-2018

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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