CClinicalTrials.gg
CompletedNCT05671172Updated Sep 19, 2025

Effect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section

An interventional study of Hyaluronidase and Bupivacaine Injection in Pain, Postoperative, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Benha University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Pain, Postoperative

Browse trials for

03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 114 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • parturients who aged between 18-40 years old
  • with ASA physical status grade II and
  • scheduled for elective CS under spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    Group H1

    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.

    Drug: Hyaluronidase

  • Experimental
    Group H2

    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.

    Drug: Hyaluronidase

  • Placebo comparator
    Group C

    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.

    Drug: Bupivacaine Injection

Interventions

  • DrugHyaluronidase

    hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS

  • DrugBupivacaine Injection

    20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS

06

What researchers measure

Primary outcomes

  1. the duration of analgesia

    the interval between performing the block and the time of the first request for analgesia.

    Time frame: 24 hours postoperative

Secondary outcomes

  1. the postoperative pain severity

    pain was assessed by the visual analog scale (VAS) pain score (range, 0-10; 0, no pain; 10, worst pain)

    Time frame: every 0,2,4,8,12, up to 24 hours postoperative

  2. total morphine consumption

    Time frame: at 24 hours postoperatively

  3. patient satisfaction

    assessed on a four-point scale (1, excellent; 2, good; 3, fair; 4, poor)

    Time frame: at 24 hours postoperatively

07

Study locations

1 site
  • Samar Rafik Amin
    Banhā, Qalyubia Governorate 13511, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05671172
Lead sponsor
Benha University
Responsible party
Samar Rafik Mohamed Amin (Doctor, Benha University) — Principal investigator
First posted
Jan 4, 2023
Start date
May 15, 2023
Primary completion
Jan 10, 2024
Completion
Feb 10, 2024
Last update
Sep 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion