Anesthesia, LocalNCT04782960
Subconjunctival Bupivacaine in Strabismus Surgery
A study testing Iocal anaesthetic bupivacaine in people with Anesthesia, Local, run by Fayoum University.
Trial summary
This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Iocal anaesthetic bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to May 2021
- 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 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients aged 14 _30 years old with body mass index 18_28kg/m.
- American Anaesthesiologist Association physical states I,II.
- singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.
Who cannot join
- were patients with chronic pain.
- ocular hypertension.
- inability to communicate.
- history of hematological disease.
- allergy to local anesthetic drugs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia
This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.
Read the detailed description
40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.
- Conditions
- Anesthesia, Local
- Being tested
- Iocal anaesthetic bupivacaine, Placebo
- Keywords
- Subconjunctival bupivacaine., Strabismus surgery., Postoperative analgesia.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iocal anaesthetic bupivacaineDrug
Also called Group (p)
Local anaesthetic Subconjunctival bupivacaine
PlaceboDrug
Also called Group (s)
0.9 saline
| Study group | Role | What they receive |
|---|---|---|
| 20 patients receive Subconjunctival bupivacaine of the end of the surgery | Active comparator | 20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score Receives: Drug: Iocal anaesthetic bupivacaine |
| 20 patients receive Subconjunctival placebo in the end of operation | Placebo comparator | 20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) pain score
Range, 0_10;0,no pain ;10,worst pain
Measured: 5 minutes after extubation
Secondary outcomes (1)
Nausea and vomiting
Operation related side effect
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
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.
- More trials run by Fayoum 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abeer shaban, Fayoum University
- Investigators
- Mohammad A Hamed, MD, Study director, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782960
- Sponsor's protocol ID
- Subconjunctival bupivacaine
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- 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 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subconjunctival Bupivacaine Injection in Squint Surgery for Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT04782960
- Acronym / sponsor ID
- Subconjunctival bupivacaine
- Conditions
- Anesthesia, Local
- Keywords
- Subconjunctival bupivacaine., Strabismus surgery., Postoperative analgesia.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 4 Mar 2021 (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.
This study aimed to assess the effectiveness of the Subconjunctival bupivacaine on postoperative pain in Strabismus surgery under general anaesthesia.
Detailed description
40 patients will schedule for elective Strabismus surgery under general anaesthesia and randomly allocated into two groups to receive Subconjunctival 0.5%Bupivacaine group(B) or Subconjunctival placebo 0.9% normal saline group at the end of the surgery and assess the postoperative pain at 0th,30th, 60th,2nd h, 4h,6h,12h,24h.and post operative nausea and vomiting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 patients receive Subconjunctival bupivacaine of the end of the surgery | Active comparator | Drug: Iocal anaesthetic bupivacaine20 patients receive Subconjunctival bupivacaine in the end of operation and monitoring postoperative pain score |
| 20 patients receive Subconjunctival placebo in the end of operation | Placebo comparator | Drug: Placebo20 patients receive Subconjunctival placebo in the end of operation and monitoring postoperative pain score |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All patients aged 14 _30 years old with body mass index 18_28kg/m.
- American Anaesthesiologist Association physical states I,II.
- singed informed consent to participate in the study and were scheduled for strabismus operations under general anaesthesia.
Key exclusion criteria (5 listed)
- were patients with chronic pain.
- ocular hypertension.
- inability to communicate.
- history of hematological disease.
- allergy to local anesthetic drugs.
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 |
|---|---|---|
| Iocal anaesthetic bupivacaineAlso: Group (p)Local anaesthetic Subconjunctival bupivacaine | Drug | 20 patients receive Subconjunctival bupivacaine of the end of the surgery |
| PlaceboAlso: Group (s)0.9 saline | Drug | 20 patients receive Subconjunctival placebo in the end of operation |
Primary outcome
Visual analog scale (VAS) pain score
Time frame: 5 minutes after extubation
Range, 0_10;0,no pain ;10,worst pain
1 secondary outcome
Nausea and vomiting
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Local
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
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.
Mohammad A Hamed, MD study director
Fayoum University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Iocal anaesthetic bupivacaine in people with Anesthesia, Local, run by Fayoum 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 5 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 Mar 2021. 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. 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.
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 Abeer Sh Goda (01005151706, Asg06@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) pain score (time frame: 5 minutes after extubation). 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 Mar 2021.