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NCT Number: NCT04921007

Ultrasound Guided Sacral Erector Spinae Plane Block in Pediatric Anorectal Surgery

This study will be conducted to evaluate efficacy of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pediatric anorectal surgery in comparison to caudal block.

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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

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

Regional anesthesia in children has become increasingly popular over the past few decades. A variety of peripheral and central nerve blocks have been developed to ensure that perioperative pain can be effectively controlled. So, it possible to reduce the dose concentrations of systemic drugs and improved hemodynamic stability in high-risk patients. Erector spinae plane (ESP) block with various approaches been used in many surgeries and obtained great popularity despite of its novelty. After first description; lower thoracic, lumbar and sacral approaches were defined for postoperative analgesia. There are a few cases in which sacral ESP block was administered and reported.

The aim of this study is to compare postoperative analgesic effect of ultrasound guided sacral ESP block and caudal block. It is hypothesized that sacral ESP block will be comparable to caudal block as a promising effective alternative for analgesia in patients who will undergo pediatric anorectal surgery with fewer side effects.

This prospective, randomized, comparative clinical study will include 60 children who will be scheduled for elective anorectal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality. The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to two equal groups (ESP and caudal) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for pediatric anorectal surgery

Exclusion criteria

  • Parental refusal of consent.
  • Children with developmental delays, mental or neurological disorders.
  • Bleeding or coagulation diathesis.
  • History of known sensitivity to the used anesthetics.
  • Infection or redness at the injection site.

Treatment and study plan

Sacral ESP Block

Procedure

A high-frequency ultrasound linear probe covered with a sterile sheath will be placed longitudinally to the midline of the sacrum. The median sacral crests and erector spinae muscle will be visualized, then a 22-gauge, 50 mm needle will be advanced from cranial to caudal direction until its tip touch the sacral crest.

Other names: Ultrasound guided approach

Caudal block

Procedure

A high-frequency ultrasound linear probe covered with a sterile sheath will be placed on to the sacrococcygeal region. The dura mater, epidural space, conus medullaris, sacral cornua, and sacrococcygeal ligament will be identified. Using the in-plane technique, a 22-gauge, 50 mm needle will be introduced to reach the sacral epidural space.

Other names: Ultrasound guided approach

Bupivacaine Hydrochloride

Drug

Following negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected.

Other names: Marcaine

Primary outcomes

  1. Duration for the first analgesic request

    Time frame: Up to 24 hours after the procedure

    The time of the first analgesic request for paracetamol in minutes will be recorded.

Secondary outcomes

  1. Total analgesic requirements of paracetamol

    Time frame: Up to 24 hours after the procedure

    The amount of paracetamol consumption in milligrams given as a rescue analgesia

  2. Improvement in pain scores

    Time frame: Up to 24 hours after the procedure

    Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed postoperatively at 1, 2, 4, 8, 12, 24 hours

  3. Changes in heart rate

    Time frame: Up to end of the surgery

    Heart rate (beat/min) is recorded at ten-minute intervals until the end of the surgery.

  4. Changes in mean arterial blood pressure

    Time frame: Up to end of the surgery

    Blood pressure (mmHg) is recorded at ten-minute intervals until the end of the surgery.

  5. Changes in postoperative emergence agitation scale

    Time frame: Up to 30 minutes after the procedure

    Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)

  6. Value of parent satisfaction from the procedure

    Time frame: Up to 24 hours after the procedure

    The parents will be investigated postoperatively for the quality of the procedure verbally (0-10; 0=None, 10=total satisfaction)

Sponsors and collaborators

Lead sponsor

Sameh Fathy

Other

Registry information

Official study title

Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Caudal Block in Pediatric Anorectal Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2021
Registry last updated
Jul 7, 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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