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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Hyaluronidase
* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group H1<br>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<br>* hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS<br>|
| Experimental: Group H2<br>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<br>* hyaluronidase will be applied as adjuvant to bupivacaine in transversus abdominis plane block to enhance the postoperative analgesic effect after CS<br>|
| Placebo Comparator: Group C<br>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<br>* 20ml bupivacaine will be injected without additives in the transversus abdominis plane block on each side for postoperative analgesic after CS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the duration of analgesia | the interval between performing the block and the time of the first request for analgesia. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the postoperative pain severity | pain was assessed by the visual analog scale (VAS) pain score (range, 0-10; 0, no pain; 10, worst pain) | every 0,2,4,8,12, up to 24 hours postoperative | 
| total morphine consumption |  | at 24 hours postoperatively | 
| patient satisfaction | assessed on a four-point scale (1, excellent; 2, good; 3, fair; 4, poor) | at 24 hours postoperatively |