Local Anesthesia AdjuvantsNCT05767827
Effect of Dexmedetomidine As Adjuvant to Ropivacaine for Brachial Plexus Block
A study testing ropivacaine, lidocaine with adrenaline and Dexmedetomidine, ropivacaine, lidocaine with adrenaline in people with Local Anesthesia Adjuvants and Upper Extremity Fracture, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
Trial summary
Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Local Anesthesia Adjuvants, Upper Extremity Fracture, Brachial Plexus Block
- What is being tested?
- ropivacaine, lidocaine with adrenaline and Dexmedetomidine, ropivacaine, lidocaine with adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNepal
- Study dates
- 1 Feb 2023to 30 Aug 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I and II patients, weight 45 to 74 kg
- Elective upper limb surgery under brachial plexus block
Who cannot join
- known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine
- Pregnant or lactating mothers
- Hepatic, renal or cardiopulmonary abnormalities
- Long term analgesic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.
- Being tested
- ropivacaine, lidocaine with adrenaline, Dexmedetomidine, ropivacaine, lidocaine with adrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine, lidocaine with adrenalineDrug
Group R includes 0.35% ropivacaine 20ml, 1.5 % lidocaine with adrenaline 10ml
Dexmedetomidine, ropivacaine, lidocaine with adrenalineDrug
Dexmedetomidine 1mcg/kg and 0.35% ropivacaine with normal saline (20ml), 1.5% lidocaine with adrenaline (10ml) in group RD
| Study group | Role | What they receive |
|---|---|---|
| Group R | Active comparator | 0.35% ropivacaine 20ml, 1.5% lidocaine with adrenaline 10ml = 30 ml Receives: Drug: ropivacaine, lidocaine with adrenaline |
| Group RD | Experimental | 0.35% ropivacaine and 1mcg/ kg dexmedetomidine (20 ml), 1.5% lidocaine with adrenaline (10ml) = 30 ml Receives: Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine
Analgesia will be assessed with the help of Visual analogue score ( VAS). VAS greater than 3 will be given inj.ketorolac 30mg IV.
Measured: 5 months
Assess the onset of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
Sensory block assessed by 3point scale
0 normal sensation
- loss of sensation of pinprick
- loss of sensation of touch Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0).Motor blockade assessed by modified Bromage scale (MBS)
0-able to raise extended arm to 90 degree for full two seconds
- able to flex elbow, move fingers but unable to raise extended arm
- unable to flex elbow but able to move fingers
- unable to move arm, elbow, fingers Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).
Measured: 5 months
Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0).
Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).
Measured: 5months
Secondary outcomes (1)
Assess any complications of study drugs
Complications like bradycardia assessed by continue ECG monitoring, Hypotension will be assessed by NIBP
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Feb 2023
- Primary completion30 Jul 2023
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anesthesia AdjuvantsStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepal Medical College and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Yadav, Nepal Medical College and Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767827
- Sponsor's protocol ID
- NepalMCTH
- Status last verified
- Aug 2024
- First submitted
- 14 Feb 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine As Adjuvant to Ropivacaine for Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT05767827
- Acronym / sponsor ID
- NepalMCTH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nepal Medical College and Teaching HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 14 Mar 2023 (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.
Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R | Active comparator | Drug: ropivacaine, lidocaine with adrenaline0.35% ropivacaine 20ml, 1.5% lidocaine with adrenaline 10ml = 30 ml |
| Group RD | Experimental | Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline0.35% ropivacaine and 1mcg/ kg dexmedetomidine (20 ml), 1.5% lidocaine with adrenaline (10ml) = 30 ml |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I and II patients, weight 45 to 74 kg
- Elective upper limb surgery under brachial plexus block
Key exclusion criteria (4 listed)
- known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine
- Pregnant or lactating mothers
- Hepatic, renal or cardiopulmonary abnormalities
- Long term analgesic therapy
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 |
|---|---|---|
| ropivacaine, lidocaine with adrenalineGroup R includes 0.35% ropivacaine 20ml, 1.5 % lidocaine with adrenaline 10ml | Drug | Group R |
| Dexmedetomidine, ropivacaine, lidocaine with adrenalineDexmedetomidine 1mcg/kg and 0.35% ropivacaine with normal saline (20ml), 1.5% lidocaine with adrenaline (10ml) in group RD | Drug | Group RD |
Primary outcome
Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine
Time frame: 5 months
Analgesia will be assessed with the help of Visual analogue score ( VAS). VAS greater than 3 will be given inj.ketorolac 30mg IV.
Assess the onset of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
Time frame: 5 months
Sensory block assessed by 3point scale 0 normal sensation 1. loss of sensation of pinprick 2. loss of sensation of touch Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0).Motor blockade assessed by modified Bromage scale (MBS) 0-able to raise extended arm to 90 degree for full two seconds 1. able to flex elbow, move fingers but unable to raise extended arm 2. unable to flex elbow but able to move fingers 3. unable to move arm, elbow, fingers Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).
Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine
Time frame: 5months
Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0). Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0).
1 secondary outcome
Assess any complications of study drugs
Time frame: 5 months
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 4 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine, lidocaine with adrenaline and Dexmedetomidine, ropivacaine, lidocaine with adrenaline in people with Local Anesthesia Adjuvants and Upper Extremity Fracture, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
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 2 inclusion and 4 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 4 Sep 2024. 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 Nepal. 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?
Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine (time frame: 5 months). The study lists 3 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 4 Sep 2024.