Perioperative Complication PainNCT04614259
Perioperative Pain Management for Cleft Lip in Children
A study testing Bupivacain and i.v. analgesia in people with Perioperative Complication Pain, run by Cairo University.
Trial summary
Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group. Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Complication Pain
- What is being tested?
- Bupivacain and i.v. analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2020to Dec 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 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- good physical condition.
- Age 6 months to 3 years.
- Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .
Who cannot join
- Children posted for combined procedures like congenital heart correction with palatoplasty .
- Parents refusal .
- Bleeding disorders( platelets count < 100.000 , international ratio >1.5).
- Skin lesions or wounds at site of needle insertion .
- Co-morbidities as congenital heart disease , lung pathology or central nervous system
- Known hypersensitivity to local anesthetics or opioids .
About this study
Official title: Perioperative Pain Management for Cleft Lip Repair in Children, Bilateral Infraorbital Nerve Block Versus Conventional Methods( Combined IV Fentanyl With Peri Incisional Infiltration). A Randomized Comparative Study
Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.
- Conditions
- Perioperative Complication Pain
- Being tested
- Bupivacain, i.v. analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
The infraorbital foramen was located at the floor of the orbital rim at about the level of the pupil,The upper lip was folded back and a finger is placed externally at the level of the infraorbital foramen to prevent the needle from the cephalad insertion in the globe of the eye. A 27-gauge needle was bent about 70 degree to ease the insertion through the buccal mucosa over the maxillary process, towards the infraorbital foramen.
After careful aspiration the local anesthetic was injected (injection of 3 ml 0.25% bupivacaine in 1:200.000 adrenaline ,1.5 ml on each side). [104] Pressure was needed to be applied for one minute to the area as there is loose adventitious tissue that can lead to swelling and ecchymosis
i.v. analgesiaCombination product
Using inhalational induction with sevoflurane as tolerated , atracurium 0.5mg/kg to facilitate endotracheal intubation and fentanyl 1 mcg/kg ,Mechanical ventilation was adjusted to maintain 30 to 35 mmHg end-tidal carbon dioxide, anesthesia was maintained with 1.5 % isoflurane and atracurium (0.1 mg/kg every 30 minutes) ,all patients were received intraoperative diclofenac sodium 0.5 mg/kg intramuscular .
Blood pressure and heart rate were measured 5 minutes after endotracheal intubation and every 15 minutes till recovery from the anesthesia then every 15 min in the postoperative care unite for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| intravenous analgesia | Experimental | Not described Receives: Combination Product: i.v. analgesia |
| infraorbital nerve block | Experimental | Not described Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Total rescue doses of morphine
Measured: 24 huors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start15 Nov 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perioperative Complication PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsonbaty, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614259
- Sponsor's protocol ID
- N 49-2018/Ms
- Status last verified
- Nov 2020
- First submitted
- 21 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not share
Publications
Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
PubMed 460932Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
PubMed 16118385Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
Doyle E, Hudson I. Anesthesia for primary repair of cleft lip and cleft palate: a review of 244 procedures. Paediatr Anaesth 1992; 2: 139-145.
Takemura H, Yasumoto K, Toi T, Hosoyamada A. Correlation of cleft type with incidence of perioperative respiratory complications in infants with cleft lip and palate. Paediatr Anaesth. 2002 Sep;12(7):585-8. doi: 10.1046/j.1460-9592.2002.00906.x.
PubMed 12358652
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pain Management for Cleft Lip Repair in Children, Bilateral Infraorbital Nerve Block Versus Conventional Methods( Combined IV Fentanyl With Peri Incisional Infiltration). A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04614259
- Acronym / sponsor ID
- N 49-2018/Ms
- Conditions
- Perioperative Complication Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Nov 2020 (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.
Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous analgesia | Experimental | Combination Product: i.v. analgesia |
| infraorbital nerve block | Experimental | Drug: Bupivacain |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- good physical condition.
- Age 6 months to 3 years.
- Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .
Key exclusion criteria (6 listed)
- Children posted for combined procedures like congenital heart correction with palatoplasty .
- Parents refusal .
- Bleeding disorders( platelets count < 100.000 , international ratio >1.5).
- Skin lesions or wounds at site of needle insertion .
- Co-morbidities as congenital heart disease , lung pathology or central nervous system
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 |
|---|---|---|
| BupivacainThe infraorbital foramen was located at the floor of the orbital rim at about the level of the pupil,The upper lip was folded back and a finger is placed externally at the level of the infraorbital foramen to prevent the needle from the cephalad insertion in the globe of the eye. A 27-gauge needle was bent about 70 degree to ease the insertion through the buccal mucosa over the maxillary process, towards the infraorbital foramen. After careful aspiration the local anesthetic was injected (injection of 3 ml 0.25% bupivacaine in 1:200.000 adrenaline ,1.5 ml on each side). [104] Pressure was needed to be applied for one minute to the area as there is loose adventitious tissue that can lead to swelling and ecchymosis | Drug | infraorbital nerve block |
| i.v. analgesiaUsing inhalational induction with sevoflurane as tolerated , atracurium 0.5mg/kg to facilitate endotracheal intubation and fentanyl 1 mcg/kg ,Mechanical ventilation was adjusted to maintain 30 to 35 mmHg end-tidal carbon dioxide, anesthesia was maintained with 1.5 % isoflurane and atracurium (0.1 mg/kg every 30 minutes) ,all patients were received intraoperative diclofenac sodium 0.5 mg/kg intramuscular . Blood pressure and heart rate were measured 5 minutes after endotracheal intubation and every 15 minutes till recovery from the anesthesia then every 15 min in the postoperative care unite for 30 minutes | Combination product | intravenous analgesia |
Primary outcome
Postoperative opioid consumption
Time frame: 24 huors
Total rescue doses of morphine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 460932Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
- Background: PubMed 16118385Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
- BackgroundTremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
- BackgroundDoyle E, Hudson I. Anesthesia for primary repair of cleft lip and cleft palate: a review of 244 procedures. Paediatr Anaesth 1992; 2: 139-145.
- Background: PubMed 12358652Takemura H, Yasumoto K, Toi T, Hosoyamada A. Correlation of cleft type with incidence of perioperative respiratory complications in infants with cleft lip and palate. Paediatr Anaesth. 2002 Sep;12(7):585-8. doi: 10.1046/j.1460-9592.2002.00906.x.
- Individual participant dataSharing planned: No. Do not share
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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 Bupivacain and i.v. analgesia in people with Perioperative Complication Pain, run by Cairo University.
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 3 inclusion and 6 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 4 Nov 2020. 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?
Results are not available in the source record.
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?
Postoperative opioid consumption (time frame: 24 huors). 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 NCT04614259, which also lists 5 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 4 Nov 2020.