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Completed

NCT Number: NCT05820503

Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children

The goal of this study was to compare the incidence of pain and recovery agitation after single-port laparoscopic inguinal hernia repair in children. The main questions it aims to answer are:

* Reduction of postoperative pain by rectus sheath block compared with local anesthesia infiltration and control group * A comparison between rectus sheath block and local anesthesia infiltration and control group on the reduction of agitation during postoperative recovery If there is a comparison group: The researchers will compare the ultrasound-guided rectus sheath group with the local anesthesia infiltration group and the control group to look at postoperative pain indicators and the incidence of waking agitation.

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Key information

Conditions

Quality of Recovery

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 0513, China

About this study

Postoperative emergence delirium is a common phenomenon in clinical practice, with an incidence rate of up to 20% to 80%. It has long been a concern and research topic in the medical community. In recent years, with the continuous improvement and updating of anesthesia technology, research on pediatric emergence delirium has become more and more in-depth.

The goal of this study was to compare the incidence of pain and recovery agitation after single-port laparoscopic inguinal hernia repair in children. The main questions it aims to answer are:

  • Reduction of postoperative pain by rectus sheath block compared with local anesthesia infiltration and control group
  • A comparison between rectus sheath block and local anesthesia infiltration and control group on the reduction of agitation during postoperative recovery If there is a comparison group: The researchers will compare the ultrasound-guided rectus sheath group with the local anesthesia infiltration group and the control group to look at postoperative pain indicators and the incidence of waking agitation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 5~12 years old Male and female Single hole inguinal hernia repair surgery should be performed Parents volunteered to participate in the study and signed an informed consent

Exclusion criteria

  • Preexisting neuropathy Coagulopathy Local skin infection Hepatic, renal, or cardiorespiratory failure Local anesthetic allergy

Treatment and study plan

Ultrasound-guided lower abdominis rectus sheath block

Procedure

Under ultrasound guidance, the probe was transversely placed at the lateral level of the umbilicus . Using the in-plane technique, the needle was advanced until the posterior aspect of the rectus muscle was penetrated. No blood and no gas were drawn back; furthermore, a small volume of saline was initially injected to ensure that the needle tip was correctly positioned. When the needle was located between the posterior rectus muscle and posterior sheath, 5ml of 0.25% ropivacaine was injected bilaterally

Local anesthesia infiltration

Procedure

Local anesthesia drugs were injected into the peri-umbilicus cord

Primary outcomes

  1. Face Legs Activity Cry Consolability (FLACC) score

    Time frame: 0,2, 4, 6, 12, 24, 36, and 48 hours postoperatively

    The Face Legs Activity Cry Consolability (FLACC) scale method is an effective method mainly used for postoperative pain assessment in children . It includes 5 contents: Face, Legs, Activity, Cry and Consolability. Each item is scored on a scale of 0 to 2, with the highest total score being 10. Using the FLACC scale method, doctors need to observe children for 1 to 15 minutes. The pain score is obtained by the medical staff according to the observed children's situation and the content in the quantification table. The total score is obtained by adding up the scores of each content, ranging from 0 to 10. The higher the score, the higher the pain. Doctors can observe children during routine checkups. Touch and change the child's position to determine the child's pain and better assess its body tension and resistance.

  2. Pediatric Anesthesia Emergence Delirium (PAED) scale

    Time frame: Assessments were performed 5 minutes and 10 minutes after awakening, and the highest score was taken

    The PAED scale is a reliable tool for assessing postoperative delirium in children, including 5 scoring items, namely eye contact with caregivers, purposeful activities, cognition of the surrounding environment, and the uneasiness and comfort of children. Each evaluation item can be divided into levels 1 to 5 according to the degree, with 0 to 4 points respectively, and the maximum total score is 20 points. A score of ≥10 on the PAED scale indicates the presence of postoperative delirium, and a score of ≥15 indicates the presence of severe postoperative delirium

Secondary outcomes

  1. Cumulative use of anesthetic drugs during surgery

    Time frame: Perioperative period

    The cumulative use of remifentanil and propofol during the operation.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

Effect of Ultrasound-guided Rectus Abdominis Sheath Block on Analgesia and Agitation During the Awakening Period in Children After Single-port Laparoscopic Inguinal Hernia Repair

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Jan 5, 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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