Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children

NCT ID: NCT05820503

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Quality of Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ultrasound-guided lower abdominis rectus sheath block

Intervention Type 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

Control group

Do nothing with it

Group Type NO_INTERVENTION

No interventions assigned to this group

Local anesthesia infiltration Group

Local anesthesia drugs were injected into the peri-umbilicus cord

Group Type EXPERIMENTAL

Local anesthesia infiltration

Intervention Type PROCEDURE

Local anesthesia drugs were injected into the peri-umbilicus cord

Interventions

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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

Intervention Type PROCEDURE

Local anesthesia infiltration

Local anesthesia drugs were injected into the peri-umbilicus cord

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Zhang

Role: PRINCIPAL_INVESTIGATOR

Ethics Committee of Affiliated Hospital of Nantong University

Locations

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Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2021-K036

Identifier Type: -

Identifier Source: org_study_id

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