Back to resultsEffect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hyaluronidase
Bupivacaine Injection
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
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: 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).
Sites / Locations
- Samar Rafik AminRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group H1
Group H2
Group C
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
the duration of analgesia
the interval between performing the block and the time of the first request for analgesia.
Secondary Outcome Measures
the postoperative pain severity
pain was assessed by the visual analog scale (VAS) pain score (range, 0-10; 0, no pain; 10, worst pain)
total morphine consumption
patient satisfaction
assessed on a four-point scale (1, excellent; 2, good; 3, fair; 4, poor)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05671172
Brief Title
Effect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group H1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group H2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hyaluronidase
Intervention Description
hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS
Primary Outcome Measure Information:
Title
the duration of analgesia
Description
the interval between performing the block and the time of the first request for analgesia.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
the postoperative pain severity
Description
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
Title
total morphine consumption
Time Frame
at 24 hours postoperatively
Title
patient satisfaction
Description
assessed on a four-point scale (1, excellent; 2, good; 3, fair; 4, poor)
Time Frame
at 24 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar R Amin
Phone
01287793991
Email
samar.rafik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elsayed M Abdelzaam
Email
sayedzim12@yahoo.com
Facility Information:
Facility Name
Samar Rafik Amin
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar R. Amin, lecturer
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Adding Hyaluronidase to Bupivacaine in Transversus Abdominis Plane Block for Cesarean Section
We'll reach out to this number within 24 hrs