Clinical trial NCT05820503: Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Recovery
Keywords: Nerve block
Hernia in the groin
PAED score
FLACC score
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 112
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Face Legs Activity Cry Consolability (FLACC) score
timeFrame: 0,2, 4, 6, 12, 24, 36, and 48 hours postoperatively
measure: Pediatric Anesthesia Emergence Delirium (PAED) scale
timeFrame: Assessments were performed 5 minutes and 10 minutes after awakening, and the highest score was taken
Secondary outcomes:
measure: Cumulative use of anesthetic drugs during surgery
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Ethics Committee of Affiliated Hospital of Nantong University
name: Tao Zhang
role: PRINCIPAL_INVESTIGATOR
References: