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

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

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 .

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: conventional analgesia; Procedure: ultrasound guided erector spinae plane block; Procedure: ultrasound guided paravertebral block

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: R 97/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No