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NCT Number: NCT05448469

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

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 .

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

conventional analgesia

Drug

patients will receive combined general anesthesia and conventional analgesia

Primary outcomes

  1. First time to analgesic requirement

    Time frame: 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 outcomes

  1. total analgesic consumption

    Time frame: 1st 24 hour

    The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.

  2. Numerical rating scale (NRS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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