Pain, PostoperativeNCT05671172
Effect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section
A study testing Hyaluronidase and Bupivacaine Injection in people with Pain, Postoperative, run by Benha University at 1 site in Egypt.
Trial summary
Since TAP block needs to affect several nerves in single tissue plane with a single prick, hyaluronidase is expected to aid greatly in the spread of the LA and help the block. However, there have not been adequate studies to establish the efficacy of adding hyaluronidase in lateral TAP after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Hyaluronidase and Bupivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 10 Feb 2024
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- parturients who aged between 18-40 years old
- with ASA physical status grade II and
- scheduled for elective CS under spinal anesthesia
Who cannot join
- patients with ASA grade III or IV,
- refusal to participate,
- emergency CS or complicated pregnancy,
- those with bleeding disorders or on anticoagulants,
- those with severe respiratory and cardiovascular diseases,
- having any local infection at the injection site,
- history of allergy to one of the used drugs,
- obese patients (body mass index ≥ 30 kg/m2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Two Different Doses of Hyaluronidase to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Post-cesarean Section Analgesia; A Randomized Controlled Double Blinded Study.
Since TAP block needs to affect several nerves in single tissue plane with a single prick, hyaluronidase is expected to aid greatly in the spread of the LA and help the block. However, there have not been adequate studies to establish the efficacy of adding hyaluronidase in lateral TAP after cesarean section. Hence, the present study was carried out to evaluate the efficacy of hyaluronidase in different concentrations added to bupivacaine in US-guided bilateral lateral TAP block.
- Conditions
- Pain, Postoperative
- Being tested
- Hyaluronidase, Bupivacaine Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaluronidaseDrug
hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS
Bupivacaine InjectionDrug
20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS
| Study group | Role | What they receive |
|---|---|---|
| Group H1 | Experimental | patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 750 IU hyaluronidase as an adjuvant in each side after closing skin. Receives: Drug: Hyaluronidase |
| Group H2 | Experimental | patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 1500 IU hyaluronidase as an adjuvant in each side after closing skin. Receives: Drug: Hyaluronidase |
| Group C | Placebo comparator | patients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline without any adjuvant in each side after closing skin. Receives: Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of analgesia
the interval between performing the block and the time of the first request for analgesia.
Measured: 24 hours postoperative
Secondary outcomes (3)
the postoperative pain severity
pain was assessed by the visual analog scale (VAS) pain score (range, 0-10; 0, no pain; 10, worst pain)
Measured: every 0,2,4,8,12, up to 24 hours postoperative
total morphine consumption
Measured: at 24 hours postoperatively
patient satisfaction
assessed on a four-point scale (1, excellent; 2, good; 3, fair; 4, poor)
Measured: at 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 Jan 2023
- Study start15 May 2023
- Primary completion10 Jan 2024
- Study completion10 Feb 2024
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.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671172
- Sponsor's protocol ID
- RC 4-8-2022
- Status last verified
- Sep 2025
- First submitted
- 1 Jan 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Two Different Doses of Hyaluronidase to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Post-cesarean Section Analgesia; A Randomized Controlled Double Blinded Study.
- ClinicalTrials.gov ID
- NCT05671172
- Acronym / sponsor ID
- RC 4-8-2022
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 4 Jan 2023 (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.
Since TAP block needs to affect several nerves in single tissue plane with a single prick, hyaluronidase is expected to aid greatly in the spread of the LA and help the block. However, there have not been adequate studies to establish the efficacy of adding hyaluronidase in lateral TAP after cesarean section. Hence, the present study was carried out to evaluate the efficacy of hyaluronidase in different concentrations added to bupivacaine in US-guided bilateral lateral TAP block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group H1 | Experimental | Drug: Hyaluronidasepatients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 750 IU hyaluronidase as an adjuvant in each side after closing skin. |
| Group H2 | Experimental | Drug: Hyaluronidasepatients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline containing 1500 IU hyaluronidase as an adjuvant in each side after closing skin. |
| Group C | Placebo comparator | Drug: Bupivacaine Injectionpatients will received TAB block with 19 ml bupivacaine 0.25 % plus 1 ml 0.9% normal saline without any adjuvant in each side after closing skin. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- parturients who aged between 18-40 years old
- with ASA physical status grade II and
- scheduled for elective CS under spinal anesthesia
Key exclusion criteria (8 listed)
- patients with ASA grade III or IV,
- refusal to participate,
- emergency CS or complicated pregnancy,
- those with bleeding disorders or on anticoagulants,
- those with severe respiratory and cardiovascular 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 |
|---|---|---|
| Hyaluronidasehyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS | Drug | Group H1, Group H2 |
| Bupivacaine Injection20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS | Drug | Group C |
Primary outcome
the duration of analgesia
Time frame: 24 hours postoperative
the interval between performing the block and the time of the first request for analgesia.
3 secondary outcomes
the postoperative pain severity
Time frame: every 0,2,4,8,12, up to 24 hours postoperative
total morphine consumption
Time frame: at 24 hours postoperatively
patient satisfaction
Time frame: at 24 hours postoperatively
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 19 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronidase and Bupivacaine Injection in people with Pain, Postoperative, run by Benha University 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 3 inclusion and 8 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 19 Sep 2025. 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.
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?
the duration of analgesia (time frame: 24 hours postoperative). 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 19 Sep 2025.