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Completed

NCT Number: NCT06373185

Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children

The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.

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Key information

Conditions

Urogenital Diseases Nerve Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun Research and Training Hospital

Giresun, Central, 28100, Turkey (Türkiye)

About this study

The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 1-7 years undergoing paediatric urogenital surgery
  • Patients in American Society of Anesthesiologist (ASA) class I-II

Exclusion criteria

  • Patients whose parents do not give consent
  • Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
  • Patients with known local anaesthetic allergy
  • Patients for whom regional anaesthesia is contraindicated
  • Known neurological or muscular disease

Treatment and study plan

Ultrasound-guided sacral erector spinae plane block

Procedure

Patients were received ultrasound-guided sacral erector spinae plane block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

Ultrasound-guided caudal block

Procedure

Patients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

Primary outcomes

  1. Face, Leg, Activity, Cry, Consolability (FLACC) score

    Time frame: baseline ,and 24 hours

    The FLACC is an observational pain scale. It is widely used in the paediatric population to assess pain in infants and children who are unable to verbally express their pain.Each category is scored on the 0-2 scale which results in a total score of 0-10.

Secondary outcomes

  1. Analgesic requirement

    Time frame: baseline, and 24 hours

    If the FLACC>4 and above rescue analgesics will be made

  2. Satisfaction of the patient's parents

    Time frame: 24. hours

    A questionnaire will be used in which patient's parents will indicate their satisfaction from 0 to 10. 0: not at all satisfied, 10: very satisfied

  3. Satisfaction of the surgeons

    Time frame: 24.hours

    A questionnaire will be used in which surgeon's will indicate their satisfaction from 0 to 10. 0: not at all satisfied, 10: very satisfied

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

Comparison of the Effects of Sacral Erector Spinae Plane Block and Caudal Block on Postoperative Pain Control in Pediatric Urogenital Surgery Cases

Acronym: SESPB

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Jul 22, 2024

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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