Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Recovery
• Intervention / Treatment: Procedure: Ultrasound-guided lower abdominis rectus sheath block; Procedure: Local anesthesia infiltration

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 0513
      • Affiliated Hospital of Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R group :Ultrasound-guided lower abdominis rectus sheath block group; 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.	Procedure: Ultrasound-guided lower abdominis rectus sheath block; 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
No Intervention: Control group; Do nothing with it
Experimental: Local anesthesia infiltration Group; Local anesthesia drugs were injected into the peri-umbilicus cord	Procedure: Local anesthesia infiltration; Local anesthesia drugs were injected into the peri-umbilicus cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Face Legs Activity Cry Consolability (FLACC) score	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.	0,2, 4, 6, 12, 24, 36, and 48 hours postoperatively
Pediatric Anesthesia Emergence Delirium (PAED) scale	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	Assessments were performed 5 minutes and 10 minutes after awakening, and the highest score was taken

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative use of anesthetic drugs during surgery	The cumulative use of remifentanil and propofol during the operation.	Perioperative period

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: Tao Zhang, Ethics Committee of Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Nerve block; Hernia in the groin; PAED score; FLACC score
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2021-K036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No