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

Phase 3

Completed

• Conditions: Analgesia
• Interventions: Drug: conventional analgesia; Procedure: ultrasound guided erector spinae plane block; Procedure: ultrasound guided paravertebral block

• Registration Number: NCT05448469
• Lead Sponsor: Ain Shams University

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-07
• Study Start: 2022-07-10
• Status Verified: 2022-12
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia	conventional analgesia	general anesthesia plus conventional analgesia
general anesthesia+ bilateral US guided erector spinae plane block	ultrasound guided erector spinae plane block	General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9
general anesthesia+ bilateral US guided paravertebral block	ultrasound guided paravertebral block	General anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10

Primary Outcome Measures

Name	Time	Method
First time to analgesic requirement	1st 24 hour	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.

Secondary Outcome Measures

Name	Time	Method
total analgesic consumption	1st 24 hour	The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.
Numerical rating scale (NRS)	1st 24 hour	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.

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt