Anesthesia, LocalPhase 4NCT03721081
Local Anesthesia for Pediatric Cochlear Implant
A Phase 4 study testing Lidocaine 1%/Epi 1:200000 and Na Cl 0.9%/Epi 1:200000 in people with Anesthesia, Local, run by Wahba bakhet at 1 site in Egypt.
Trial summary
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Lidocaine 1%/Epi 1:200000 and Na Cl 0.9%/Epi 1:200000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2014to 26 Aug 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA I-II physical status,
- age between 1 and 6 year,
Who cannot join
- known allergy to local anesthetics,
- predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Local Anesthetic Infiltration Reduces Opioid Requirements Without Attenuation of the Intraoperative Evoked Stapedial Reflex Thresholds in Pediatric Cochlear Implant Surgery
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Local anesthesia (LA) is commonly used as an adjunct to general anesthesia in children; however, otologists are usually reluctant in the use of LA as it can cause abolishment of the electrical stapedial reflex threshold (ESRT).
Read the detailed description
Seventy children (1-6 years) undergoing CI were recruited. Children were divided into two groups. The LA group received subcutaneous infiltration of 0.5 ml/kg lidocaine 1% in adrenaline 1:200,000 and the CT group received 0.5 ml/kg of Na CI 0.9% in adrenaline 1:200,000. The primary outcome was number of patients requiring rescue analgesia (tramadol) during the first 24-h postoperative. Secondary outcomes were haemodynamic variables, the ESRT, intraoperative anesthetic requirements, time to LMA removal, time to total recovery, pain scores, time to first rescue analgesia and incidence of vomiting.
- Conditions
- Anesthesia, Local
- Being tested
- Lidocaine 1%/Epi 1:200000, Na Cl 0.9%/Epi 1:200000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1%/Epi 1:200000Drug
Also called Xylocaine 1%/Epi 1:200000
Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Lidocaine 1%/Epi 1:200000 Inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.
Na Cl 0.9%/Epi 1:200000Other
Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Na CI 0.9%/Epi 1:200000 inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.
| Study group | Role | What they receive |
|---|---|---|
| Na Cl 0.9%/Epi 1:200000 | Placebo comparator | Subcutaneous infiltration of Na Cl 0.9%/Epi 1:200000 Receives: Other: Na Cl 0.9%/Epi 1:200000 |
| Lidocaine 1%/Epi 1:200000 | Active comparator | Subcutaneous infiltration of Lidocaine 1%/Epi 1:200000 Receives: Drug: Lidocaine 1%/Epi 1:200000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients requiring rescue opioid analgesia (Tramal)
Post-operative Pain assessed by the pediatric observational Faces, Legs, Activity, Cry Consolability (FLACC) score with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
Measured: During the length of hospital stay post surgery (on average 24 hours)
Secondary outcomes (6)
The operative time
Minutes
Measured: Intraoperative
The anesthesia time.
Minutes
Measured: Intraoperative
Heart rate
beats per minute
Measured: Intraoperative
mean arterial blood pressure
mm Hg
Measured: Intraoperative
ESRT responses
The surgeon assessed ESRT response at the basal, middle, and apical areas of the electrode array by visual monitoring of the stapedius muscle using direct microscopic examination
Measured: Intraoperative
Anesthetic consumption
propofol and remifentanil requirement after the bolus
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Aug 2014
- Primary completion26 Aug 2016
- Study completion26 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wahba bakhet
- Sponsor type
- University, hospital or other
- Collaborators
- Bahteem Specialized Hospital
- Responsible party
- Sponsor-investigator, Wahba bakhet, Ain Shams University
- Investigators
- wahba Z Bakhet, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721081
- Sponsor's protocol ID
- WBAKHET-LA
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Local Anesthetic Infiltration Reduces Opioid Requirements Without Attenuation of the Intraoperative Evoked Stapedial Reflex Thresholds in Pediatric Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT03721081
- Acronym / sponsor ID
- WBAKHET-LA
- Conditions
- Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wahba bakhetUniversity, hospital or other
- Collaborators
- Bahteem Specialized Hospital
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- 26 Aug 2016 (actual)
- First posted
- 26 Oct 2018 (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.
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Local anesthesia (LA) is commonly used as an adjunct to general anesthesia in children; however, otologists are usually reluctant in the use of LA as it can cause abolishment of the electrical stapedial reflex threshold (ESRT).
Detailed description
Seventy children (1-6 years) undergoing CI were recruited. Children were divided into two groups. The LA group received subcutaneous infiltration of 0.5 ml/kg lidocaine 1% in adrenaline 1:200,000 and the CT group received 0.5 ml/kg of Na CI 0.9% in adrenaline 1:200,000. The primary outcome was number of patients requiring rescue analgesia (tramadol) during the first 24-h postoperative. Secondary outcomes were haemodynamic variables, the ESRT, intraoperative anesthetic requirements, time to LMA removal, time to total recovery, pain scores, time to first rescue analgesia and incidence of vomiting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Na Cl 0.9%/Epi 1:200000 | Placebo comparator | Other: Na Cl 0.9%/Epi 1:200000Subcutaneous infiltration of Na Cl 0.9%/Epi 1:200000 |
| Lidocaine 1%/Epi 1:200000 | Active comparator | Drug: Lidocaine 1%/Epi 1:200000Subcutaneous infiltration of Lidocaine 1%/Epi 1:200000 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II physical status,
- age between 1 and 6 year,
Key exclusion criteria (2 listed)
- known allergy to local anesthetics,
- predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.
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 |
|---|---|---|
| Lidocaine 1%/Epi 1:200000Also: Xylocaine 1%/Epi 1:200000Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Lidocaine 1%/Epi 1:200000 Inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution. | Drug | Lidocaine 1%/Epi 1:200000 |
| Na Cl 0.9%/Epi 1:200000Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Na CI 0.9%/Epi 1:200000 inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution. | Other | Na Cl 0.9%/Epi 1:200000 |
Primary outcome
number of patients requiring rescue opioid analgesia (Tramal)
Time frame: During the length of hospital stay post surgery (on average 24 hours)
Post-operative Pain assessed by the pediatric observational Faces, Legs, Activity, Cry Consolability (FLACC) score with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
6 secondary outcomes
The operative time
Time frame: Intraoperative
The anesthesia time.
Time frame: Intraoperative
Heart rate
Time frame: Intraoperative
mean arterial blood pressure
Time frame: Intraoperative
ESRT responses
Time frame: Intraoperative
Anesthetic consumption
Time frame: Intraoperative
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 29 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
wahba Z Bakhet, MD principal investigator
Ain Shams University
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 1%/Epi 1:200000 and Na Cl 0.9%/Epi 1:200000 in people with Anesthesia, Local, run by Wahba bakhet 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 2 inclusion and 2 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 29 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 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.
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?
number of patients requiring rescue opioid analgesia (Tramal) (time frame: During the length of hospital stay post surgery (on average 24 hours)). 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 29 Oct 2019.