Postoperative PainNCT04000100
Neostigmine for Ultrasound Guided Supraclavicular Brachial Plexus Block
A study testing ultrasound- guided supraclavicular brachial plexus block in people with Postoperative Pain, run by ABEER HASSANIN at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ultrasound- guided supraclavicular brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2018to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- ultrasound- guided supraclavicular brachial plexus block
- Keywords
- Neostigmine, Bupivacaine, Supraclavicular brachial plexus block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound- guided supraclavicular brachial plexus blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | This group received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline Receives: Procedure: ultrasound- guided supraclavicular brachial plexus block |
| Neostigmine group | Active comparator | This group received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg) Receives: Procedure: ultrasound- guided supraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Every 1 hour for 24 hours
Secondary outcomes (2)
Duration of analgesia (first request for analgesic)
The time from local anesthetic administration to the patient's first request for analgesic medication by hours
Measured: 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)
Measured: 2,4,6,8,12,16,20 and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start15 Jul 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABEER HASSANIN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ABEER HASSANIN, Minia University
- Investigators
- Ebrahim Abbas, MD, Study director, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000100
- Sponsor's protocol ID
- 72-7-2018
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data can be shared
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect OF Adding Neostigmine to Bupivacaine for Ultrasound Guided Supraclavicular Brachial Plexus Block in Forearm Surgeries
- ClinicalTrials.gov ID
- NCT04000100
- Acronym / sponsor ID
- 72-7-2018
- Conditions
- Postoperative Pain
- Keywords
- Neostigmine, Bupivacaine, Supraclavicular brachial plexus block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ABEER HASSANINUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: ultrasound- guided supraclavicular brachial plexus blockThis group received supraclavicular block using 25mL of 0. 5% bupivacaine and 1 mL normal saline |
| Neostigmine group | Active comparator | Procedure: ultrasound- guided supraclavicular brachial plexus blockThis group received 25 mL 0. 5% bupivacaine and 1 mL neostigmine (0.5 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA ( I-II)
- Age: from ≥18 years
- Sex: male or female
- type of operation : Forearm Orthopedic surgeries
- Type of anaesthesia : supraclavicular brachial plexus block
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound- guided supraclavicular brachial plexus blockPatient 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 | Procedure or surgery | Control group, Neostigmine group |
Primary outcome
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
2 secondary outcomes
Duration of analgesia (first request for analgesic)
Time frame: Every 30 minutes for 4 hours then every 2 hours for 24 hours
Visual analogue pain score
Time frame: 2,4,6,8,12,16,20 and 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: Yes. all data can be shared
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebrahim Abbas, MD study director
faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound- guided supraclavicular brachial plexus block in people with Postoperative Pain, run by ABEER HASSANIN at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The onset of sensory blockade (time frame: Every 2 minutes for 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.