Pain, PostoperativeNCT04212611
Postoperative Analgesic Effects of Infraorbital Nerve Block in Cleft Palate Surgery
A study testing INFRA ORBITAL BLOCK in people with Pain, Postoperative, run by All India Institute of Medical Sciences, Rishikesh at 1 site in India.
Trial summary
Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- INFRA ORBITAL BLOCK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2019to 1 Mar 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in the age of 2-12 years
- Children undergoing elective surgery for cleft palate.
- Children who are conscious and willing to participate in the study.
- Children who speak and understand English, Hindi, local or others.
Who cannot join
- Patient's refusal
- Allergy to the amide group of local anaesthetic agent
- Patient on anticoagulants or bleeding disorder
- Underlying other significant systemic diseases.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
AIIMS Rishikesh
Rishikesh, Uttarakhand, 249203
Vijay Adabala, MD, 8977335129, vijay.adabala96@gmail.com
About this study
Official title: Evaluation of Postoperative Analgesic Effects of Infraorbital Nerve Block by Levobupivacaine vs Ropivacaine After Cleft Palate Surgery: A Double-blinded Randomized Trial
Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. After surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids.
Hence, regional block, using local anesthetics, becomes a good option in this surgery.
Read more
The supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .Levobupivacaine was developed after Ropivaciane was noted to be associated with less no of adverse events.. Ropivacaine has been used for peripheral block in children for surgical pain.
Though the use of Levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over Ropivacaine in cleft palate surgeries
Read the detailed description
When compared with ropivacaine, levobupivacaine is a newer, safer, longer acting local anesthetic with rapid onset and prolonged duration of analgesia and similar or more pronounced nerve blocking effects, depending on the concentration. Hence the present study is aimed to compare the effectiveness of 0.375% levobupivacaine and 0..375% ropivacaine in infra orbital block for cleft palate surgery.
- Conditions
- Pain, Postoperative
- Being tested
- INFRA ORBITAL BLOCK
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFRA ORBITAL BLOCKDrug
Also called Group L and Group R
Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) Receives: Drug: INFRA ORBITAL BLOCK |
| Group R | Experimental | Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% ropivacaine (group R). Receives: Drug: INFRA ORBITAL BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the pain score from base line using the verbal rating scale (scale range: 0-5; 0: no pain, 5: strongest pain) on the day of surgery, as well as on the first and second postoperative days.
Pain is measured using verbal rating scale
Measured: Till the second post operative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Mar 2019
- Primary completion20 Jan 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Rishikesh
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ADABALA VIJAY BABU, All India Institute of Medical Sciences, Rishikesh
- Investigators
- Vijay Adabala, MD, Principal investigator, AIIMS,Rishikesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212611
- Sponsor's protocol ID
- 12
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if study comes out with a positive result we will share the data with others
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Analgesic Effects of Infraorbital Nerve Block by Levobupivacaine vs Ropivacaine After Cleft Palate Surgery: A Double-blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT04212611
- Acronym / sponsor ID
- 12
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, RishikeshOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Jan 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 27 Dec 2019 (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.
Cleft palate repair is a common surgery in children.. As such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like Pierre Robin syndrome, Treacher Collins syndrome etc. After surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids.
Hence, regional block, using local anesthetics, becomes a good option in this surgery.
The supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .Levobupivacaine was developed after Ropivaciane was noted to be associated with less no of adverse events.. Ropivacaine has been used for peripheral block in children for surgical pain.
Though the use of Levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over Ropivacaine in cleft palate surgeries
Detailed description
When compared with ropivacaine, levobupivacaine is a newer, safer, longer acting local anesthetic with rapid onset and prolonged duration of analgesia and similar or more pronounced nerve blocking effects, depending on the concentration. Hence the present study is aimed to compare the effectiveness of 0.375% levobupivacaine and 0..375% ropivacaine in infra orbital block for cleft palate surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Drug: INFRA ORBITAL BLOCKBilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) |
| Group R | Experimental | Drug: INFRA ORBITAL BLOCKBilateral infra orbital blocks is performed using 2-3 mL of 0.375% ropivacaine (group R). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children in the age of 2-12 years
- Children undergoing elective surgery for cleft palate.
- Children who are conscious and willing to participate in the study.
- Children who speak and understand English, Hindi, local or others.
Key exclusion criteria (4 listed)
- Patient's refusal
- Allergy to the amide group of local anaesthetic agent
- Patient on anticoagulants or bleeding disorder
- Underlying other significant systemic diseases.
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 |
|---|---|---|
| INFRA ORBITAL BLOCKAlso: Group L and Group RBilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R). | Drug | Group L, Group R |
Primary outcome
change in the pain score from base line using the verbal rating scale (scale range: 0-5; 0: no pain, 5: strongest pain) on the day of surgery, as well as on the first and second postoperative days.
Time frame: Till the second post operative day.
Pain is measured using verbal rating scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Individual participant dataSharing planned: Yes. if study comes out with a positive result we will share the data with others
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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.
Vijay Adabala, MD principal investigator
AIIMS,Rishikesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INFRA ORBITAL BLOCK in people with Pain, Postoperative, run by All India Institute of Medical Sciences, Rishikesh at 1 site in India.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Dec 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AJIT KUMAR, MD (9910789377, ajitdr.ajit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the pain score from base line using the verbal rating scale (scale range: 0-5; 0: no pain, 5: strongest pain) on the day of surgery, as well as on the first and second postoperative days. (time frame: Till the second post operative day.). 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 27 Dec 2019.