Effect of DrugNCT04729842
Comparison Between Bupivacaine and Ropivacaine in Patients Undergoing Forearm Surgeries Under Brachial Plexus Block
A study testing Axillary Brachial plexus block in people with Effect of Drug, run by Assam Medical College.
Trial summary
This prospective comparative randomized study was done to compare Bupivacaine and Ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block. The study compares the onset and duration of sensory block, onset and duration of motor block and duration of analgesia between these two drugs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Axillary Brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Jun 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with ASA classes I and II who gave consent and were candidates for elective forearm surgeries.
Who cannot join
- Any allergic reactions to ropivacaine, bupivacaine and lignocaine.
- All patients with hypertension, cardiac, hepatic or renal diseases.
- Pregnant women, drug abusers and psychiatric patients.
- Patient who had an anatomical or vascular abnormality in the upper extremity.
- Bleeding diathesis.
- Local infection of the axilla.
- Patient refusal.
About this study
Official title: Comparison Between Bupivacaine and Ropivacaine in Patients Undergoing Forearm Surgeries Under Axillary Brachial Plexus Block: A Prospective Comparative Randomized Study
This prospective comparative randomized study was done to compare Bupivacaine and Ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block. The study compares the onset and duration of sensory block, onset and duration of motor block and duration of analgesia between these two drugs.
Read the detailed description
This is a prospective comparative randomized study to compare Bupivacaine and Ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block. A sample size of 100 was considered who are meeting the inclusion and exclusion criteria were selected, and divided into two groups of 50 each using computer-generated randomization and allocation concealment was done using sealed sequentially numbered containers opaque envelope technique (SNOSE). One group will receive Bupivacaine and the other Ropivacaine. Patients were blind to the study. In the Bupivacaine group, 30 ml of 0.5% bupivacaine was injected equally divided and injected in four nerves (musculocutaneous, median, radial and ulnar nerves). In the Ropivacaine group, 30 ml of a solution containing 0.5% ropivacaine was equally divided and injected in the four nerves. Sensory block was tested with a 22-gauge hypodermic needle by using the pinprick test and compared with the contralateral hand. Sensory block was graded as Grade 0: Sharp pin felt, Grade 1: Analgesia, dull sensation felt and Grade 2: Anaesthesia, no sensation felt. Motor function was assessed as per the modified Bromage scale. 0: Able to raise the extended arm to 90 degrees for a full 2 sec, 1: Able to flex the elbow and move the fingers but unable to raise the extended arm, 2: Unable to flex the elbow but able to move the fingers and 3: Unable to move the arm, elbow or fingers. The onset of sensory blockade was assessed by the time from the completion of injection of the study drug till the loss of pinprick sensation. It was assessed every minute. The onset of motor blockade was assessed when there was Grade 1 motor blockade. It was assessed every minute. Duration of sensory blockade was assessed by the time between onset of sensory blockade and return of dull sensation to pinprick. .It was assessed every 15 minutes. Duration of motor blockade was assessed by the time between onset of motor blockade and time at which patients could first move their fingers. It was assessed every 15minutes. Duration of analgesia is the time interval between the onset of sensory block and the patient's first analgesic request. The rescue analgesia in the form of inj. Diclofenac sodium (1.5 mg/kg) intramuscularly was given. Block was considered to have failed when sensory anaesthesia was not achieved within 30 min. General anaesthesia was given subsequently to these patients and was excluded from the study. Again, a patient showing an allergic reaction to the intervention were also withdrawn from the study.
Statistical Analysis - Normally distributed quantitative data were presented as mean ± SD, whereas data not normally distributed were presented as median (IQR). While comparing quantitative data between the two groups, for normally distributed quantitative data, Independent student t-test was used, on the other hand, Mann-Whitney test was used. For comparing qualitative variable chi-square or Fischer exact test was applied as appropriate. In case of repeated measure data, mixed effect ANOVA was used. For all test P value of < 0.05 was considered as significant and P-value < 0.001 was considered as highly significant. SPSS version 21 (IBM, Newyork) was used for data analysis.
- Conditions
- Effect of Drug
- Being tested
- Axillary Brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary Brachial plexus blockProcedure or surgery
Also called Brachial plexus block for forearm surgeries
Brachial plexus block via axillary route was administered using 30 ml of 0.5% Bupivacaine in group B and 30 ml of 0.5% Ropivacaine in Group R
| Study group | Role | What they receive |
|---|---|---|
| Group - B , Patients who recieved Bupivacaine | Active comparator | 30 ml of 0.5% bupivacaine was injected equally divided and injected in four nerves (musculocutaneous, median, radial and ulnar nerves) Receives: Procedure: Axillary Brachial plexus block |
| Group - R , Patients who received Ropivacaine | Active comparator | 30 ml of a solution containing 0.5% ropivacaine was equally divided and injected in the four nerves (musculocutaneous, median, radial and ulnar nerves) Receives: Procedure: Axillary Brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of sensory block
Sensory block was tested with a 22-gauge hypodermic needle by using the pinprick test and compared with the contra-lateral hand. Sensory block was graded as Grade 0: Sharp pin felt, Grade 1: Analgesia, dull sensation felt and Grade 2: Anaesthesia, no sensation felt.
Measured: Time in minutes from the completion of injection of the study drug till the loss of pinprick sensation. The estimated time frame from injection of study drug to onset of sensory block is 15 minutes.
Duration of sensory block
Duration was assessed from loss of pinprick sensation to return of sensation.
Measured: Time in minutes between onset of sensory blockade and return of dull sensation to pin prick. The estimated time frame for duration of sensory block is 540 minutes.
Secondary outcomes (3)
Onset of motor block
Motor function was assessed as per modified Bromage Scale . 0: Able to raise the extended arm to 90o for a full 2 sec, 1: Able to flex the elbow and move the fingers but unable to raise the extended arm, 2: Unable to flex the elbow but able to move the fingers and 3: Unable to move the arm, elbow or fingers .
Measured: Time from the completion of injection of the study drug till the patient is unable to move his fingers. The estimated time frame for onset of motor block is 20 minutes.
Duration of motor block
Duration was assessed from loss of motor function till the return of the function.
Measured: Time in minutes between onset of motor blockade and time at which patient could first move their fingers. The estimated time frame for duration of motor block is 480 minutes.
Duration of analgesia
Duration was assessed from the onset of loss of sensory function till the patient feels pain. The rescue analgesia in the form of inj. Diclofenac sodium (1.5 mg/kg) intramuscularly was given.
Measured: Time in minutes between onset of sensory block and patient's first analgesic request. Time frame for duration of analgesia is 600 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jul 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugStudies 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
- Model description
- a prospective randomized single-blind study. Patients were blind to the study of drugs. Blinding was achieved by the examiner of the study. Participants were randomly allocated into two groups (Group - B i.e. Bupivacaine Group and Group - R i.e. Ropivacaine group) using computer-generated randomization and allocation concealment was done using sealed sequentially numbered containers opaque envelope technique (SNOSE)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Karuna Kumar Das, Assam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729842
- Sponsor's protocol ID
- AssamMC
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brennan F, Lohman D, Gwyther L. Access to Pain Management as a Human Right. Am J Public Health. 2019 Jan;109(1):61-65. doi: 10.2105/AJPH.2018.304743.
PubMed 32941757Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
PubMed 19282714Armstrong KP, Cherry RA. Brachial plexus anesthesia compared to general anesthesia when a block room is available. Can J Anaesth. 2004 Jan;51(1):41-4. doi: 10.1007/BF03018545.
PubMed 14709459Clarkson CW, Hondeghem LM. Mechanism for bupivacaine depression of cardiac conduction: fast block of sodium channels during the action potential with slow recovery from block during diastole. Anesthesiology. 1985 Apr;62(4):396-405.
PubMed 2580463Hickey R, Hoffman J, Ramamurthy S. A comparison of ropivacaine 0.5% and bupivacaine 0.5% for brachial plexus block. Anesthesiology. 1991 Apr;74(4):639-42. doi: 10.1097/00000542-199104000-00002.
PubMed 2008942De Andres J, Sala-Blanch X. Peripheral nerve stimulation in the practice of brachial plexus anesthesia: a review. Reg Anesth Pain Med. 2001 Sep-Oct;26(5):478-83. doi: 10.1053/rapm.2001.26485. No abstract available.
PubMed 11561271Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002 Feb 16;359(9306):614-8. doi: 10.1016/S0140-6736(02)07750-4.
PubMed 11867132Cline E, Franz D, Polley RD, Maye J, Burkard J, Pellegrini J. Analgesia and effectiveness of levobupivacaine compared with ropivacaine in patients undergoing an axillary brachial plexus block. AANA J. 2004 Oct;72(5):339-45.
PubMed 15529729Thornton KL, Sacks MD, Hall R, Bingham R. Comparison of 0.2% ropivacaine and 0.25% bupivacaine for axillary brachial plexus blocks in paediatric hand surgery. Paediatr Anaesth. 2003 Jun;13(5):409-12. doi: 10.1046/j.1460-9592.2003.01065.x.
PubMed 12791114Kooloth RA, Patel SN, Mehta MK. A comparison of 0.5% Ropivacaine and 0.5% Bupivacaine in supraclavicular brachial plexus block -. National Journal of Medical Research. 2015;5(1):67-70.
Kaur A, Singh RB, Tripathi RK, Choubey S. Comparision between bupivacaine and ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block: a prospective randomized study. J Clin Diagn Res. 2015 Jan;9(1):UC01-6. doi: 10.7860/JCDR/2015/10556.5446. Epub 2015 Jan 1.
PubMed 25738062Rathod H, Parikh H, Upadhayaya RM. Comparative study of 0.375% bupivacaine and 0.375% ropivacaine in brachial plexus block via supraclavicular approach. Int Jour of Biomed Res. 2015 Feb 28;6(2):77-82.
Modak S, Basantwani S. Comparative study of 0.5% ropivacaine and 0.5% bupivacaine for brachial plexus block by supraclavicular approach for upper limb surgeries. International Journal of Basic & Clinical Pharmacology. 2017 Jan 5;5(4):1205-9.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bupivacaine and Ropivacaine in Patients Undergoing Forearm Surgeries Under Axillary Brachial Plexus Block: A Prospective Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT04729842
- Acronym / sponsor ID
- AssamMC
- Conditions
- Effect of Drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assam Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 29 Jan 2021 (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.
This prospective comparative randomized study was done to compare Bupivacaine and Ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block. The study compares the onset and duration of sensory block, onset and duration of motor block and duration of analgesia between these two drugs.
Detailed description
This is a prospective comparative randomized study to compare Bupivacaine and Ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block. A sample size of 100 was considered who are meeting the inclusion and exclusion criteria were selected, and divided into two groups of 50 each using computer-generated randomization and allocation concealment was done using sealed sequentially numbered containers opaque envelope technique (SNOSE). One group will receive Bupivacaine and the other Ropivacaine. Patients were blind to the study. In the Bupivacaine group, 30 ml of 0.5% bupivacaine was injected equally divided and injected in four nerves (musculocutaneous, median, radial and ulnar nerves). In the Ropivacaine group, 30 ml of a solution containing 0.5% ropivacaine was equally divided and injected in the four nerves. Sensory block was tested with a 22-gauge hypodermic needle by using the pinprick test and compared with the contralateral hand. Sensory block was graded as Grade 0: Sharp pin felt, Grade 1: Analgesia, dull sensation felt and Grade 2: Anaesthesia, no sensation felt. Motor function was assessed as per the modified Bromage scale. 0: Able to raise the extended arm to 90 degrees for a full 2 sec, 1: Able to flex the elbow and move the fingers but unable to raise the extended arm, 2: Unable to flex the elbow but able to move the fingers and 3: Unable to move the arm, elbow or fingers. The onset of sensory blockade was assessed by the time from the completion of injection of the study drug till the loss of pinprick sensation. It was assessed every minute. The onset of motor blockade was assessed when there was Grade 1 motor blockade. It was assessed every minute. Duration of sensory blockade was assessed by the time between onset of sensory blockade and return of dull sensation to pinprick. .It was assessed every 15 minutes. Duration of motor blockade was assessed by the time between onset of motor blockade and time at which patients could first move their fingers. It was assessed every 15minutes. Duration of analgesia is the time interval between the onset of sensory block and the patient's first analgesic request. The rescue analgesia in the form of inj. Diclofenac sodium (1.5 mg/kg) intramuscularly was given. Block was considered to have failed when sensory anaesthesia was not achieved within 30 min. General anaesthesia was given subsequently to these patients and was excluded from the study. Again, a patient showing an allergic reaction to the intervention were also withdrawn from the study.
Statistical Analysis - Normally distributed quantitative data were presented as mean ± SD, whereas data not normally distributed were presented as median (IQR). While comparing quantitative data between the two groups, for normally distributed quantitative data, Independent student t-test was used, on the other hand, Mann-Whitney test was used. For comparing qualitative variable chi-square or Fischer exact test was applied as appropriate. In case of repeated measure data, mixed effect ANOVA was used. For all test P value of < 0.05 was considered as significant and P-value < 0.001 was considered as highly significant. SPSS version 21 (IBM, Newyork) was used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a prospective randomized single-blind study. Patients were blind to the study of drugs. Blinding was achieved by the examiner of the study. Participants were randomly allocated into two groups (Group - B i.e. Bupivacaine Group and Group - R i.e. Ropivacaine group) using computer-generated randomization and allocation concealment was done using sealed sequentially numbered containers opaque envelope technique (SNOSE)
| Arm | Type | Receives |
|---|---|---|
| Group - B , Patients who recieved Bupivacaine | Active comparator | Procedure: Axillary Brachial plexus block30 ml of 0.5% bupivacaine was injected equally divided and injected in four nerves (musculocutaneous, median, radial and ulnar nerves) |
| Group - R , Patients who received Ropivacaine | Active comparator | Procedure: Axillary Brachial plexus block30 ml of a solution containing 0.5% ropivacaine was equally divided and injected in the four nerves (musculocutaneous, median, radial and ulnar nerves) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with ASA classes I and II who gave consent and were candidates for elective forearm surgeries.
Key exclusion criteria (7 listed)
- Any allergic reactions to ropivacaine, bupivacaine and lignocaine.
- All patients with hypertension, cardiac, hepatic or renal diseases.
- Pregnant women, drug abusers and psychiatric patients.
- Patient who had an anatomical or vascular abnormality in the upper extremity.
- Bleeding diathesis.
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 |
|---|---|---|
| Axillary Brachial plexus blockAlso: Brachial plexus block for forearm surgeriesBrachial plexus block via axillary route was administered using 30 ml of 0.5% Bupivacaine in group B and 30 ml of 0.5% Ropivacaine in Group R | Procedure or surgery | Group - B , Patients who recieved Bupivacaine, Group - R , Patients who received Ropivacaine |
Primary outcome
Onset of sensory block
Time frame: Time in minutes from the completion of injection of the study drug till the loss of pinprick sensation. The estimated time frame from injection of study drug to onset of sensory block is 15 minutes.
Sensory block was tested with a 22-gauge hypodermic needle by using the pinprick test and compared with the contra-lateral hand. Sensory block was graded as Grade 0: Sharp pin felt, Grade 1: Analgesia, dull sensation felt and Grade 2: Anaesthesia, no sensation felt.
Duration of sensory block
Time frame: Time in minutes between onset of sensory blockade and return of dull sensation to pin prick. The estimated time frame for duration of sensory block is 540 minutes.
Duration was assessed from loss of pinprick sensation to return of sensation.
3 secondary outcomes
Onset of motor block
Time frame: Time from the completion of injection of the study drug till the patient is unable to move his fingers. The estimated time frame for onset of motor block is 20 minutes.
Duration of motor block
Time frame: Time in minutes between onset of motor blockade and time at which patient could first move their fingers. The estimated time frame for duration of motor block is 480 minutes.
Duration of analgesia
Time frame: Time in minutes between onset of sensory block and patient's first analgesic request. Time frame for duration of analgesia is 600 minutes
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 10 Feb 2021.
- Background: PubMed 32941757Brennan F, Lohman D, Gwyther L. Access to Pain Management as a Human Right. Am J Public Health. 2019 Jan;109(1):61-65. doi: 10.2105/AJPH.2018.304743.
- Background: PubMed 19282714Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
- Background: PubMed 14709459Armstrong KP, Cherry RA. Brachial plexus anesthesia compared to general anesthesia when a block room is available. Can J Anaesth. 2004 Jan;51(1):41-4. doi: 10.1007/BF03018545.
- Background: PubMed 2580463Clarkson CW, Hondeghem LM. Mechanism for bupivacaine depression of cardiac conduction: fast block of sodium channels during the action potential with slow recovery from block during diastole. Anesthesiology. 1985 Apr;62(4):396-405.
- Background: PubMed 2008942Hickey R, Hoffman J, Ramamurthy S. A comparison of ropivacaine 0.5% and bupivacaine 0.5% for brachial plexus block. Anesthesiology. 1991 Apr;74(4):639-42. doi: 10.1097/00000542-199104000-00002.
- Background: PubMed 11561271De Andres J, Sala-Blanch X. Peripheral nerve stimulation in the practice of brachial plexus anesthesia: a review. Reg Anesth Pain Med. 2001 Sep-Oct;26(5):478-83. doi: 10.1053/rapm.2001.26485. No abstract available.
- Background: PubMed 11867132Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002 Feb 16;359(9306):614-8. doi: 10.1016/S0140-6736(02)07750-4.
- Background: PubMed 15529729Cline E, Franz D, Polley RD, Maye J, Burkard J, Pellegrini J. Analgesia and effectiveness of levobupivacaine compared with ropivacaine in patients undergoing an axillary brachial plexus block. AANA J. 2004 Oct;72(5):339-45.
- Background: PubMed 12791114Thornton KL, Sacks MD, Hall R, Bingham R. Comparison of 0.2% ropivacaine and 0.25% bupivacaine for axillary brachial plexus blocks in paediatric hand surgery. Paediatr Anaesth. 2003 Jun;13(5):409-12. doi: 10.1046/j.1460-9592.2003.01065.x.
- BackgroundKooloth RA, Patel SN, Mehta MK. A comparison of 0.5% Ropivacaine and 0.5% Bupivacaine in supraclavicular brachial plexus block -. National Journal of Medical Research. 2015;5(1):67-70.
- Results publication: PubMed 25738062Kaur A, Singh RB, Tripathi RK, Choubey S. Comparision between bupivacaine and ropivacaine in patients undergoing forearm surgeries under axillary brachial plexus block: a prospective randomized study. J Clin Diagn Res. 2015 Jan;9(1):UC01-6. doi: 10.7860/JCDR/2015/10556.5446. Epub 2015 Jan 1.
- Results publicationRathod H, Parikh H, Upadhayaya RM. Comparative study of 0.375% bupivacaine and 0.375% ropivacaine in brachial plexus block via supraclavicular approach. Int Jour of Biomed Res. 2015 Feb 28;6(2):77-82.
- OpenEpi - Toolkit Shell for Developing New Applications \[Internet\].Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary Brachial plexus block in people with Effect of Drug, run by Assam Medical College.
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 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 of sensory block (time frame: Time in minutes from the completion of injection of the study drug till the loss of pinprick sensation. The estimated time frame from injection of study drug to onset of sensory block is 15 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04729842, which also lists 13 linked publications.
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 10 Feb 2021.