Injection Site IrritationPhase 4NCT01824758
Effect of Esmolol on Pain Due to Rocuronium
A Phase 4 study testing Lidocaine, Esmolol and rocuronium in people with Injection Site Irritation, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site Irritation
- What is being tested?
- Lidocaine, Esmolol and rocuronium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to May 2013
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA physical status I and II patients
- Undergoing general anesthesia for elective surgery
Who cannot join
- Known allergy to esmolol or lidocaine
- Chronic pain
- Pregnancy
- Withdrawal of consent by the patient
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Teaching and Research Hospital
Ankara, Altindag
About this study
Official title: The Effect of Esmolol on Pain Due to Rocuronium Injection Pain
90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0.5 mg/kg rocuronium.
Read the detailed description
Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.
- Conditions
- Injection Site Irritation
- Being tested
- Lidocaine, Esmolol, rocuronium, Placebo
- Keywords
- esmolol, injection pain, lidocaine, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Aritmal, Jetmonal
Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).
EsmololDrug
Also called brevibloc
Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)
rocuroniumDrug
0.05 mg/kg rocuronium
PlaceboDrug
Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| brevibloc (esmolol) | Experimental | Group E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL) Receives: Drug: Esmolol; Drug: rocuronium |
| Aritmal (Lidocaine) | Active comparator | Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL) Receives: Drug: Lidocaine; Drug: rocuronium |
| Placebo (NaCl 0.9%, 5 ml) | Placebo comparator | Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL) Receives: Drug: rocuronium; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The injection pain due to rocuronium
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
Measured: 1 month
Secondary outcomes (1)
Score on pain due to injection of rocuronium
Withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site IrritationStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Fakelma 05327079113, Principal investigator, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824758
- Sponsor's protocol ID
- ESM 0538
- Status last verified
- Oct 2019
- First submitted
- 1 Mar 2013
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esmolol on Pain Due to Rocuronium Injection Pain
- ClinicalTrials.gov ID
- NCT01824758
- Acronym / sponsor ID
- ESM 0538
- Conditions
- Injection Site Irritation
- Keywords
- esmolol, injection pain, lidocaine, rocuronium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Apr 2013 (estimated)
- 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.
90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0.5 mg/kg rocuronium.
Detailed description
Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| brevibloc (esmolol) | Experimental | Drug: Esmolol, Drug: rocuroniumGroup E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL) |
| Aritmal (Lidocaine) | Active comparator | Drug: Lidocaine, Drug: rocuroniumGroup E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL) |
| Placebo (NaCl 0.9%, 5 ml) | Placebo comparator | Drug: rocuronium, Drug: PlaceboGroup E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I and II patients
- Undergoing general anesthesia for elective surgery
Key exclusion criteria (4 listed)
- Known allergy to esmolol or lidocaine
- Chronic pain
- Pregnancy
- Withdrawal of consent by the patient
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 |
|---|---|---|
| LidocaineAlso: Aritmal, JetmonalGroup L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg). | Drug | Aritmal (Lidocaine) |
| EsmololAlso: breviblocGroup E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg) | Drug | brevibloc (esmolol) |
| rocuronium0.05 mg/kg rocuronium | Drug | Aritmal (Lidocaine), Placebo (NaCl 0.9%, 5 ml), brevibloc (esmolol) |
| PlaceboGroup C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg) | Drug | Placebo (NaCl 0.9%, 5 ml) |
Primary outcome
The injection pain due to rocuronium
Time frame: 1 month
Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).
1 secondary outcome
Score on pain due to injection of rocuronium
Time frame: 1 month
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 Oct 2019.
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.
Fakelma 05327079113 principal investigator
Diskapi Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine, Esmolol and rocuronium in people with Injection Site Irritation, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
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 Oct 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 injection pain due to rocuronium (time frame: 1 month). 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 Oct 2019.