Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children

NCT05820503 | Completed

• 1 other identifier: 2021-K036
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Recovery

Keywords

Nerve block; Hernia in the groin; PAED score; FLACC score

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cumulative use of anesthetic drugs during surgery

  Perioperative period

Study Arms (3)

R group :Ultrasound-guided lower abdominis rectus sheath block group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Do nothing with it

Local anesthesia infiltration Group

EXPERIMENTAL

Local anesthesia drugs were injected into the peri-umbilicus cord

Procedure: Local anesthesia infiltration

Interventions

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

R group :Ultrasound-guided lower abdominis rectus sheath block group

Local anesthesia infiltration PROCEDURE

Local anesthesia drugs were injected into the peri-umbilicus cord

Local anesthesia infiltration Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 0513, China

Location

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Tao Zhang

  Ethics Committee of Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)