Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy

Study Overview
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Brief Summary
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The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg Group 2: bupivacaine 0.25% Group3: control group A prospective Randomized Interventional double-blind study.

Detailed Description
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Optimal dynamic analgesia is recognized as the key to enhanced recovery following open abdominal surgery. In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard. Various techniques have tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and trans muscular quadratus lumborum analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for providing analgesia following ventral hernia repair. The unique feature of the ultrasound-guided truncal blocks is that in all of these techniques, in contrast to peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is injected in a particular muscle plane, in which the injectate spreads and reaches the intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.

Official Title
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Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: bupivacaine
* Drug: dexamethasone
* Drug: placebo to dexamethasone
* Drug: placebo to bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy Exclusion Criteria: Participants had known sensitivity to bupivacaine Participants had difficulty in intubation Participants were on chronic pain medication or already on long-term opioids Participants smokers Participants with disabilities who were unable to communicate pain levels refuse to consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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
Interventional Model Description: A prospective Randomized Interventional double-blind study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine and dexamethasone<br>Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline. | Drug: bupivacaine<br>* Bilateral TAP block with 20 ml of 0.25% bupivacaine<br>* Other names: Active Comparator;Drug: dexamethasone<br>* Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.<br>* Other names: active comparator;|
| Active Comparator: bupivacaine and placebo to dexamethasone<br>Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone | Drug: bupivacaine<br>* Bilateral TAP block with 20 ml of 0.25% bupivacaine<br>* Other names: Active Comparator;Drug: placebo to dexamethasone<br>* Bilateral TAP block with placebo to dexamethasone.<br>|
| Placebo Comparator: control group<br>Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone | Drug: placebo to dexamethasone<br>* Bilateral TAP block with placebo to dexamethasone.<br>Drug: placebo to bupivacaine<br>* Bilateral TAP block with placebo to bupivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score for pain during movement | movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain | 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score for pain during rest | ranging from 0 to 10, where 0 no pain and 10 maximum pain | 24 hours postoperative | 
| number of patients need Fentanyl consumption | calculation of the number of patients need Fentanyl consumption | 24 hours postoperative | 
| number of days patients stay in hospital | calculation of number of days patients stay in hospital | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae plane block, total abdominal hysterectomy, dexamethasone