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Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Pain | Procedure: ultrasound- guided supraclavicular brachial plexus block | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | Effect OF Adding Neostigmine to Bupivacaine for Ultrasound Guided Supraclavicular Brachial Plexus Block in Forearm Surgeries |
| Actual Study Start Date : | July 15, 2018 |
| Actual Primary Completion Date : | January 15, 2019 |
| Actual Study Completion Date : | January 15, 2019 |
| 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 |
- The onset of sensory blockade [ Time Frame: Every 2 minutes for 30 minutes ]Onset time for sensory block was defined as the time interval between the end of local anesthetic administration untill complete sensory block by minutes
- The onset of motor blockade [ Time Frame: Every 2 minutes for 30 minutes ]Onset time for motor block was defined as the time interval between the end of local anesthetic administration until complete motor block by minutes
- Duration of sensory blockade [ Time Frame: Every 1 hour for 24 hours ]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
- Duration of motor blockade [ Time Frame: Every 1 hour for 24 hours ]the time interval from complete motor block to complete recovery of motor function of hand and forearm by hours
- Duration of analgesia (first request for analgesic) [ Time Frame: Every 30 minutes for 4 hours then every 2 hours for 24 hours ]The time from local anesthetic administration to the patient's first request for analgesic medication by hours
- Visual analogue pain score [ Time Frame: 2,4,6,8,12,16,20 and 24 hours postoperative ]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)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
| Egypt | |
| Minya university hospital | |
| Minya, Egypt, 611111 | |
| Study Director: | Ebrahim Abbas, MD | faculty of medicine |
| Tracking Information | |||||||||||||
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| First Submitted Date ICMJE | June 14, 2019 | ||||||||||||
| First Posted Date ICMJE | June 27, 2019 | ||||||||||||
| Last Update Posted Date | August 7, 2019 | ||||||||||||
| Actual Study Start Date ICMJE | July 15, 2018 | ||||||||||||
| Actual Primary Completion Date | January 15, 2019 (Final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | |||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block | ||||||||||||
| Official Title ICMJE | Effect OF Adding Neostigmine to Bupivacaine for Ultrasound Guided Supraclavicular Brachial Plexus Block in Forearm Surgeries | ||||||||||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Other |
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| Condition ICMJE | Postoperative Pain | ||||||||||||
| Intervention ICMJE | 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 |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Actual Enrollment ICMJE |
80 | ||||||||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||||||||
| Actual Study Completion Date ICMJE | January 15, 2019 | ||||||||||||
| Actual Primary Completion Date | January 15, 2019 (Final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Listed Location Countries ICMJE | Egypt | ||||||||||||
| Removed Location Countries | |||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT04000100 | ||||||||||||
| Other Study ID Numbers ICMJE | 72-7-2018 | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | ABEER HASSANIN, Minia University | ||||||||||||
| Study Sponsor ICMJE | ABEER HASSANIN | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| PRS Account | Minia University | ||||||||||||
| Verification Date | August 2019 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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