Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05820503
Collaborator
(none)
120
1
3
24
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound-guided lower abdominis rectus sheath block
  • Procedure: Local anesthesia infiltration
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Face Legs Activity Cry Consolability (FLACC) score [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 [They were evaluated every 5 minutes in the first 30 minutes after surgery Postoperative delirium was assessed once and every 10 minutes for the next 30 minutes]

    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 Outcome Measures

  1. Cumulative use of anesthetic drugs during surgery [Perioperative period]

    The cumulative use of remifentanil and propofol during the operation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Nantong University Nantong Jiangsu China 0513

Sponsors and Collaborators

  • Affiliated Hospital of Nantong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Affiliated Hospital of Nantong University
ClinicalTrials.gov Identifier:
NCT05820503
Other Study ID Numbers:
  • 2021-K036
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Affiliated Hospital of Nantong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023