Clinical trial NCT04000100: Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block
Official title: Effect OF Adding Neostigmine to Bupivacaine for Ultrasound Guided Supraclavicular Brachial Plexus Block in Forearm Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Neostigmine
Bupivacaine
Supraclavicular brachial plexus block
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: The onset of sensory blockade
timeFrame: Every 2 minutes for 30 minutes
measure: The onset of motor blockade
timeFrame: Every 2 minutes for 30 minutes
measure: Duration of sensory blockade
timeFrame: Every 1 hour for 24 hours
measure: Duration of motor blockade
timeFrame: Every 1 hour for 24 hours
Secondary outcomes:
measure: Duration of analgesia (first request for analgesic)
timeFrame: Every 30 minutes for 4 hours then every 2 hours for 24 hours
measure: Visual analogue pain score
timeFrame: 2,4,6,8,12,16,20 and 24 hours postoperative
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya university hospital
Study officials:
affiliation: faculty of medicine
name: Ebrahim Abbas, MD
role: STUDY_DIRECTOR
References: