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

NCT05448469 | Completed Phase 3

• 1 other identifier: R 97/2022
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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 .

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• total analgesic consumption

  1st 24 hour

• Numerical rating scale (NRS)

  1st 24 hour

Study Arms (3)

general anesthesia+ bilateral US guided erector spinae plane block

ACTIVE COMPARATOR

General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9

Procedure: ultrasound guided erector spinae plane block

general anesthesia+ bilateral US guided paravertebral block

ACTIVE COMPARATOR

General anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10

Procedure: ultrasound guided paravertebral block

general anesthesia

ACTIVE COMPARATOR

general anesthesia plus conventional analgesia

Drug: conventional analgesia

Interventions

ultrasound guided erector spinae plane block PROCEDURE

patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.

general anesthesia+ bilateral US guided erector spinae plane block

ultrasound guided paravertebral block PROCEDURE

patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.

general anesthesia+ bilateral US guided paravertebral block

conventional analgesia DRUG

patients will receive combined general anesthesia and conventional analgesia

general anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 7, 2022
• Study Start: July 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

EG (1)