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Clinical Trials/NCT06210503
NCT06210503
Active, not recruiting
Not Applicable

The Comparison of Pericapsular Nerve Block and Fascia Iliaca Compartment Block in Children With Cerebral Palsy or Spina Bifida for Pain Management in Hip Surgery.

Saint Petersburg State University, Russia1 site in 1 country86 target enrollmentDecember 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perioperative Analgesia
Sponsor
Saint Petersburg State University, Russia
Enrollment
86
Locations
1
Primary Endpoint
Opioids consumption
Status
Active, not recruiting
Last Updated
9 months ago

Overview

Brief Summary

The goal of this clinical trial is to test the hypothesis that performing a Pericapsular nerve group (PENG) block allows for more effective analgesia in the perioperative period during reconstructive surgery on the hip in children with cerebral palsy and spina bifida compared with Fascia illiaca compartment block (FICB).

Detailed Description

The main question it aims to answer is: Is the PENG block an effective and safe method of pain relief for hip surgery in children? Participants will be randomized into two equal groups. The group who underwent US - guided PENG block, and the group who underwent US - guided FICB . In both groups we used 0.5% ropivacaine. The same postoperative analgesia regimen was applied by intravenous acetaminophen , oral ibuprofen . In case of ineffectiveness of the prescribed drugs, promedol was used intramuscularly. The postoperative consumption of promedol, time to first rescue analgesia, numerical pain score (NRS) (for children from 7 years old), FLACC score, measurements of A.N.I. monitor MDMS and the side effects will be recorded

Registry
clinicaltrials.gov
Start Date
December 4, 2023
End Date
November 1, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Saint Petersburg State University, Russia
Responsible Party
Principal Investigator
Principal Investigator

Novikova Veronika

Principal Investigator

Saint Petersburg State University, Russia

Eligibility Criteria

Inclusion Criteria

  • reconstructive surgery on the hip joint
  • children with cerebral palsy/ spina bifida/organic brain injury
  • age 3 - 18 years.

Exclusion Criteria

  • contraindications to the use of local anesthetics
  • contraindications to performing an invasive procedure

Outcomes

Primary Outcomes

Opioids consumption

Time Frame: 24 hours

Total dosage of opioids in postoperative period

Secondary Outcomes

  • Time to rescue analgesia(24 hours)
  • Pain level(2, 6, 12, 24 hours after completing the block)
  • Intraoperative level of analgesia(Intraoperatively)

Study Sites (1)

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