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Clinical Trials/NCT07281235
NCT07281235
Completed
Not Applicable

Perioperative Analgesia With Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Caudal Block in Children

Alexandria University1 site in 1 country60 target enrollmentStarted: May 1, 2024Last updated:
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Overview

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The goal of this prospective study is to is to evaluate the perioperative pain management of Erector Spinae Block versus Caudal Block using the Face, Legs, Activity, Cry, Conceal ability (FLACC) Pain Scale inn children aged 2 to 7 years old. The main question it aims to answer is:

Which block is more efficient in the perioperative period?

Participants will be evaluated intraoperative and postoperative for hemodynamic changes and their pain will evaluated according to the FLACC score.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age between 2-7 years old.
  • •ASA I-II.
  • •Elective surgery under general anaesthesia.
  • •Lower abdominal surgery.

Exclusion Criteria

  • •Parent/caregiver refusal.
  • •Allergy to one of the study medications.
  • •Renal or cardiac disease.
  • •Infection or redness at the site of injection.
  • •Clinically significant coagulopathy.
  • •Spinal anomalies.
  • •Altered mental status.
  • •Developmental delay.
  • •Additional surgery at different surgical sites.
  • •Block failure.

Outcomes

Primary Outcomes

Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block.

Time Frame: At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.

Evaluate postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. A score of 0 = no pain, 10 = severe pain. A score ≥4 requires rescue analgesia.

Secondary Outcomes

  • Changes to heart rate (beats/minute)(T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery)
  • The time to first rescue analgesic.(from 0 to 8 hours after block administration)
  • Total postoperative analgesic requirements.(from 0 to 8 hours after block administration)
  • Parent satisfaction with a 5-point Likert scale questionnaire.(At 8 hours after block administration)
  • Number of patients required rescue analgesic postoperatively.(From 0 to 8 hours after surgery.)
  • Time to Modified Aldrete score ≥9.(from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes))
  • Incidence of any adverse effects.(from end of surgery (0 hours) to 8 hours postoperatively)
  • Changes to mean arterial pressure (MAP)(T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery)
  • Changes to oxygen saturation(T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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