Tab Block QaulityEarly Phase 1NCT06839391
Effect of Hyaluronidase in Different Doses Added to Bupivacaine on TAB Block Quality During CS
A Early Phase 1 study testing Hyaluronidase in people with Tab Block Qaulity, run by Benha University.
Trial summary
evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tab Block Qaulity
- What is being tested?
- Hyaluronidase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Apr 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant 20-45 y medical free
Who cannot join
- • Hepatic.
- Renal.
- Diabetic.
- Hypertensive.
- Cardiovascular dysfunction.
About this study
evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS
Read the detailed description
Hyaluronidase acts by catalyzing the hydrolysis of hyaluronan, decreased its viscosity, and enchasing the tissue permeability. So, this makes it a suitable additive for other drugs to speed up their distribution and delivery especially in ophthalmic surgery. Several studies showed that multiple injection techniques of TAB block were more successful with a faster onset of anesthesia and higher success rates, with a change in the incidence of complications.
This double-blinded randomized prospective study was conducted to evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS . The primary outcome of this study was the duration of sensory block, while secondary outcomes included the onset of sensory block, success rate, total doses of intraoperative rescue analgesia, number of patients needed for postoperative rescue analgesia, and complications.
- Conditions
- Tab Block Qaulity
- Being tested
- Hyaluronidase
- Keywords
- hyaluronidase-bupivacaine-TAB block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaluronidaseDrug
Effect of hyaluronidases in different doses added to bupivacaine on quality of ultrasound-guided TAB block during CS ,
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | After skin closure, they got TAB block with 20 cc of 0.25 percent bupivacaine on each side without any adjuvant. Receives: Drug: Hyaluronidase |
| group II | Experimental | obtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 500 IU (100 IU/ml) of hyaluronidase (Hynidase) as an adjuvant on each side. Receives: Drug: Hyaluronidase |
| GROUP III | Experimental | obtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 1000 IU (200 IU/ml) hyaluronidase (Hynidase) as an adjuvant on each side. Receives: Drug: Hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
postoperatively pain assesment
Measured: 2-6-10-16-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tab Block QaulityStudies of the same condition, open and under way.
- More trials run by Benha 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed said MOSTAFA elmeligy, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839391
- Sponsor's protocol ID
- TAB BLOCK QAULITY
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Keeler JF, Simpson KH, Ellis FR, Kay SP. Effect of addition of hyaluronidase to bupivacaine during axillary brachial plexus block. Br J Anaesth. 1992 Jan;68(1):68-71. doi: 10.1093/bja/68.1.68.
PubMed 1739571Koh WU, Min HG, Park HS, Karm MH, Lee KK, Yang HS, Ro YJ. Use of hyaluronidase as an adjuvant to ropivacaine to reduce axillary brachial plexus block onset time: a prospective, randomised controlled study. Anaesthesia. 2015 Mar;70(3):282-9. doi: 10.1111/anae.12879. Epub 2014 Oct 28.
PubMed 25347936Kumar CM, Macachor J. Hyaluronidase for brachial plexus block. Anaesthesia. 2015 Sep;70(9):1097-8. doi: 10.1111/anae.13186. No abstract available.
PubMed 26263864
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronidase in Different Doses Added to Bupivacaine on TAB Block Quality During CS
- ClinicalTrials.gov ID
- NCT06839391
- Acronym / sponsor ID
- TAB BLOCK QAULITY
- Conditions
- Tab Block Qaulity
- Keywords
- hyaluronidase-bupivacaine-TAB block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 Feb 2025 (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.
evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS
Detailed description
Hyaluronidase acts by catalyzing the hydrolysis of hyaluronan, decreased its viscosity, and enchasing the tissue permeability. So, this makes it a suitable additive for other drugs to speed up their distribution and delivery especially in ophthalmic surgery. Several studies showed that multiple injection techniques of TAB block were more successful with a faster onset of anesthesia and higher success rates, with a change in the incidence of complications.
This double-blinded randomized prospective study was conducted to evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS . The primary outcome of this study was the duration of sensory block, while secondary outcomes included the onset of sensory block, success rate, total doses of intraoperative rescue analgesia, number of patients needed for postoperative rescue analgesia, and complications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Drug: HyaluronidaseAfter skin closure, they got TAB block with 20 cc of 0.25 percent bupivacaine on each side without any adjuvant. |
| group II | Experimental | Drug: Hyaluronidaseobtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 500 IU (100 IU/ml) of hyaluronidase (Hynidase) as an adjuvant on each side. |
| GROUP III | Experimental | Drug: Hyaluronidaseobtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 1000 IU (200 IU/ml) hyaluronidase (Hynidase) as an adjuvant on each side. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant 20-45 y medical free
Key exclusion criteria (5 listed)
- • Hepatic.
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 |
|---|---|---|
| HyaluronidaseEffect of hyaluronidases in different doses added to bupivacaine on quality of ultrasound-guided TAB block during CS , | Drug | GROUP III, group I, group II |
Primary outcome
visual analogue scale
Time frame: 2-6-10-16-24 hours postoperatively
postoperatively pain assesment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 1739571Keeler JF, Simpson KH, Ellis FR, Kay SP. Effect of addition of hyaluronidase to bupivacaine during axillary brachial plexus block. Br J Anaesth. 1992 Jan;68(1):68-71. doi: 10.1093/bja/68.1.68.
- Background: PubMed 25347936Koh WU, Min HG, Park HS, Karm MH, Lee KK, Yang HS, Ro YJ. Use of hyaluronidase as an adjuvant to ropivacaine to reduce axillary brachial plexus block onset time: a prospective, randomised controlled study. Anaesthesia. 2015 Mar;70(3):282-9. doi: 10.1111/anae.12879. Epub 2014 Oct 28.
- Background: PubMed 26263864Kumar CM, Macachor J. Hyaluronidase for brachial plexus block. Anaesthesia. 2015 Sep;70(9):1097-8. doi: 10.1111/anae.13186. No abstract available.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyaluronidase in people with Tab Block Qaulity, run by Benha 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 1 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: opening soon, as of the sponsor's last update on 21 Feb 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
visual analogue scale (time frame: 2-6-10-16-24 hours postoperatively). 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 NCT06839391, which also lists 3 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 21 Feb 2025.