Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients

Assiut University

Status and phase: Completed; Phase 3

Conditions: Pediatric Cancer

Treatments: Drug: Tramadol hydrochloride; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04613830

515

Details and patient eligibility

About

The aim of this study is to evaluate the analgesic efficacy of erector spinae plane block in pediatric cancer patients undergoing open nephrectomy

Full description

• Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30).
• All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block

Enrollment: 60 patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physical status ASA II.
• Patients (age 2-7yrs) scheduled for open nephrectomy for malignant kidney tumors

Exclusion criteria

• History of psychological disorders.

  • Known sensitivity or contraindication to local anesthetics.
  • Localized infection at the site of block.
  • patients with coagulopathy or an (INR ≥ 2)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Erector spinae group

Active Comparator group

Description:

patient will be placed in a sitting position under complete aseptic condition and a cover sheath will be used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the L3 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.

Treatment:

Drug: Bupivacaine Hydrochloride

Opioid GROUP

Placebo Comparator group

Description:

Patient in group T will intravenously administrate dose of 1 mg/kg/8hr tramal ( opioid) to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic.

Treatment:

Drug: Tramadol hydrochloride