Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy

Study Overview
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Brief Summary
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There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .

Official Title
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Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial

Conditions
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Analgesia

Intervention / Treatment
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* Procedure: ultrasound guided erector spinae plane block
* Procedure: ultrasound guided paravertebral block
* Drug: conventional analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions physical status American Society of Anesthesiologists (ASA) II or III. Exclusion Criteria: Patients who refuse to participate patients with body mass index (BMI) >35 kg/m2 infection at the site of injection coagulopathy, severe thrombocytopenia <50×103 spine deformity history of opioid dependence polytrauma patients with dorsal spine fracture urgent abdominal exploration for splenectomy in heamodynamically unstable patients history of allergy to opioids or local anesthetics history of allergy to opioids, or local anaesthetics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: general anesthesia+ bilateral US guided erector spinae plane block<br>General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9 | Procedure: ultrasound guided erector spinae plane block<br>* patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.<br>|
| Active Comparator: general anesthesia+ bilateral US guided paravertebral block<br>General anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10 | Procedure: ultrasound guided paravertebral block<br>* patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.<br>|
| Active Comparator: general anesthesia<br>general anesthesia plus conventional analgesia | Drug: conventional analgesia<br>* patients will receive combined general anesthesia and conventional analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First time to analgesic requirement | all patients received an IV -PCA system (Accufuser M8P, 60 mL; Woo Young Meditech Co, S.Korea). PCA was prepared with 60 mL of isotonic saline containing 60 mg morphine, and the selected system was adjusted to infuse a 1 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off. Breakthrough pain was managed with 2mg morphine. | 1st 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total analgesic consumption | The total dose of rescue analgesics(morphine) required in 24 hours will be recorded. | 1st 24 hour | 
| Numerical rating scale (NRS) | All patients will be monitored in the postoperative period for pain by the NRS score at rest and movement at immediate postoperative (0 min), 30 min, 1, 2, 6,12, and 24 hours. | 1st 24 hour |