Acquired Deformity of ElbowNCT04666337
Fentanyl Versus Tramadol as Co-administrator to Bupivacaine
A study testing ultrasound-guided supraclavicular brachial plexus blockade in people with Acquired Deformity of Elbow and Forearm, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Supraclavicular brachial plexus approach is an alternative technique to general anesthesia resulting in a fast onset of a reliable blockage of the brachial plexus. The use of ultrasound for the performance of supraclavicular block has become the gold standard since it enables the clinician to deposit the local… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acquired Deformity of Elbow, Forearm, Hand
- What is being tested?
- ultrasound-guided supraclavicular brachial plexus blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2019to 30 Sep 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I/II. scheduled for forearm or hand surgery
Who cannot join
- bleeding disorders
- patients who got opioid analgesics or monoamine oxidase inhibitors before surgery,
- history of seizures, respiratory or cardiac diseases
- local infections at the site where the needle for the block is to be inserted
- a pregnant woman
- the block effect was partial and required supplementary anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons
Supraclavicular brachial plexus approach is an alternative technique to general anesthesia resulting in a fast onset of a reliable blockage of the brachial plexus. The use of ultrasound for the performance of supraclavicular block has become the gold standard since it enables the clinician to deposit the local anesthetic close to the nerves in real-time that improves the success rate with a safety margin. Adjuvants are added to local anesthetic in Supraclavicular Brachial Plexus Blockade to improve the quality of nerve blocks and the duration of analgesia. It should be noted that no adjuvant has been approved by the Food and Drug Administration (FDA) for the prolongation of peripheral nerve blocks
Read the detailed description
There are multiple controversies among the previous studies for the use of different opioids as adjuvants for brachial plexus blockade to improve various block characteristics. Moreover, limited studies estimate the pons and cons of tramadol versus fentanyl as co-administrator to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade.
In our study, we aim to assess the utility of fentanyl versus tramadol as co-administrator to bupivacaine in ultrasound-guided supraclavicular brachial plexus blockade in upper limb surgeries in a prospective randomized controlled fashion. The primary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on the onset and duration of sensory and motor block and the secondary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on postoperative analgesia, time of the request to rescue analgesia, postoperative analgesic consumption, and complications.
The patients were aged between 18 and 60, both gender, and the American Society of Anesthesiologists (ASA) physical status I/II. However, patients who had bleeding disorders got opioid analgesics or monoamine oxidase inhibitors before surgery, had a history of seizures, respiratory or cardiac diseases, local infections at the site where needle for the block is to be inserted, pregnant woman and in whom the block effect was partial and required supplementary anesthesia were excluded from the study.
Patients were randomly allocated into three groups for ultrasound-guided supraclavicular brachial plexus block. Randomization was established using the computer-generated closed envelopes method.
Group B (bupivacaine group): patients received 20 ml bupivacaine 0.5% plus 2 ml normal saline Group F (fentanyl group): patients received 20 ml bupivacaine 0.5% plus fentanyl (1µg/kg-2 ml) Group T (tramadol group): patients received 20 ml bupivacaine 0.5% plus tramadol (1mg/kg-2 ml)
- Conditions
- Acquired Deformity of Elbow, Forearm, Hand, Wrist
- Being tested
- ultrasound-guided supraclavicular brachial plexus blockade
- Keywords
- Supraclavicular Brachial Plexus Blockade, Fentanyl, Tramadol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided supraclavicular brachial plexus blockadeProcedure or surgery
Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe. The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side. In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view. After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe. Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
| Study group | Role | What they receive |
|---|---|---|
| Group B (bupivacaine group) | Active comparator | patients received 20 ml bupivacaine 0.5% plus normal saline (2ml) Receives: Procedure: ultrasound-guided supraclavicular brachial plexus blockade |
| Group F (fentanyl group) | Active comparator | patients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml) Receives: Procedure: ultrasound-guided supraclavicular brachial plexus blockade |
| Group T (tramadol group) | Active comparator | patients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml) Receives: Procedure: ultrasound-guided supraclavicular brachial plexus blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of sensory block in minutes
After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).
Measured: 40 minutes
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.
Measured: 40 minutes
Duration of sensory block in hours
It's the time from sensory block onset to the time of restoration of sensation at the surgical site
Measured: 24 hours
Duration of motor block in hours
It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.
Measured: 24 hours
Secondary outcomes (6)
Visual analog scale (VAS): the VAS consisted of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you ever have" = (10 cm).
Patients were asked to rate their pain intensity at 1, 2, 4, 6, 12, 18, and 24 h after the block
Measured: 24 hours
Postoperative first analgesic request time in hours
was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm.
Measured: 24 hours
Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
was given when VAS ≥ 4 cm
Measured: 24 hours
Mean blood pressure in mmHg
was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block
Measured: 24 hours
heart rate in beats / minute
was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block.
Measured: 24 hours
peripheral oxygen saturation
was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Feb 2019
- Primary completion31 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Deformity of ElbowStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, huda fahmy, Aswan University Hospital
- Investigators
- huda fahmy, ph D, Principal investigator, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666337
- Sponsor's protocol ID
- 337/2/19
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons
- ClinicalTrials.gov ID
- NCT04666337
- Acronym / sponsor ID
- 337/2/19
- Conditions
- Acquired Deformity of Elbow, Forearm, Hand, Wrist
- Keywords
- Supraclavicular Brachial Plexus Blockade, Fentanyl, Tramadol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 14 Dec 2020 (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.
Supraclavicular brachial plexus approach is an alternative technique to general anesthesia resulting in a fast onset of a reliable blockage of the brachial plexus. The use of ultrasound for the performance of supraclavicular block has become the gold standard since it enables the clinician to deposit the local anesthetic close to the nerves in real-time that improves the success rate with a safety margin. Adjuvants are added to local anesthetic in Supraclavicular Brachial Plexus Blockade to improve the quality of nerve blocks and the duration of analgesia. It should be noted that no adjuvant has been approved by the Food and Drug Administration (FDA) for the prolongation of peripheral nerve blocks
Detailed description
There are multiple controversies among the previous studies for the use of different opioids as adjuvants for brachial plexus blockade to improve various block characteristics. Moreover, limited studies estimate the pons and cons of tramadol versus fentanyl as co-administrator to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade.
In our study, we aim to assess the utility of fentanyl versus tramadol as co-administrator to bupivacaine in ultrasound-guided supraclavicular brachial plexus blockade in upper limb surgeries in a prospective randomized controlled fashion. The primary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on the onset and duration of sensory and motor block and the secondary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on postoperative analgesia, time of the request to rescue analgesia, postoperative analgesic consumption, and complications.
The patients were aged between 18 and 60, both gender, and the American Society of Anesthesiologists (ASA) physical status I/II. However, patients who had bleeding disorders got opioid analgesics or monoamine oxidase inhibitors before surgery, had a history of seizures, respiratory or cardiac diseases, local infections at the site where needle for the block is to be inserted, pregnant woman and in whom the block effect was partial and required supplementary anesthesia were excluded from the study.
Patients were randomly allocated into three groups for ultrasound-guided supraclavicular brachial plexus block. Randomization was established using the computer-generated closed envelopes method.
Group B (bupivacaine group): patients received 20 ml bupivacaine 0.5% plus 2 ml normal saline Group F (fentanyl group): patients received 20 ml bupivacaine 0.5% plus fentanyl (1µg/kg-2 ml) Group T (tramadol group): patients received 20 ml bupivacaine 0.5% plus tramadol (1mg/kg-2 ml)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B (bupivacaine group) | Active comparator | Procedure: ultrasound-guided supraclavicular brachial plexus blockadepatients received 20 ml bupivacaine 0.5% plus normal saline (2ml) |
| Group F (fentanyl group) | Active comparator | Procedure: ultrasound-guided supraclavicular brachial plexus blockadepatients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml) |
| Group T (tramadol group) | Active comparator | Procedure: ultrasound-guided supraclavicular brachial plexus blockadepatients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I/II. scheduled for forearm or hand surgery
Key exclusion criteria (6 listed)
- bleeding disorders
- patients who got opioid analgesics or monoamine oxidase inhibitors before surgery,
- history of seizures, respiratory or cardiac diseases
- local infections at the site where the needle for the block is to be inserted
- a pregnant woman
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 blockadeUltrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe. The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side. In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view. After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe. Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery. | Procedure or surgery | Group B (bupivacaine group), Group F (fentanyl group), Group T (tramadol group) |
Primary outcome
Onset time of sensory block in minutes
Time frame: 40 minutes
After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
Time frame: 40 minutes
the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.
Duration of sensory block in hours
Time frame: 24 hours
It's the time from sensory block onset to the time of restoration of sensation at the surgical site
Duration of motor block in hours
Time frame: 24 hours
It's the time from motor block onset to the restoration of global mobility in the hand and the wrist.
6 secondary outcomes
Visual analog scale (VAS): the VAS consisted of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you ever have" = (10 cm).
Time frame: 24 hours
Postoperative first analgesic request time in hours
Time frame: 24 hours
Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
Time frame: 24 hours
Mean blood pressure in mmHg
Time frame: 24 hours
heart rate in beats / minute
Time frame: 24 hours
peripheral oxygen saturation
Time frame: 24 hours
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 16 Dec 2020.
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.
huda fahmy, ph D principal investigator
Aswan University
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 blockade in people with Acquired Deformity of Elbow and Forearm, run by Aswan University Hospital 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 1 inclusion and 6 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 16 Dec 2020. 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. 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?
Onset time of sensory block in minutes (time frame: 40 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 16 Dec 2020.