Quality of RecoveryNCT05820503
Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children
A study testing Ultrasound-guided lower abdominis rectus sheath block and Local anesthesia infiltration in people with Quality of Recovery, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Recovery
- What is being tested?
- Ultrasound-guided lower abdominis rectus sheath block and Local anesthesia infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Preexisting neuropathy Coagulopathy Local skin infection Hepatic, renal, or cardiorespiratory failure Local anesthetic allergy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Quality of Recovery
- Being tested
- Ultrasound-guided lower abdominis rectus sheath block, Local anesthesia infiltration
- Keywords
- Nerve block, Hernia in the groin, PAED score, FLACC score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided lower abdominis rectus sheath blockProcedure or surgery
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
Local anesthesia infiltrationProcedure or surgery
Local anesthesia drugs were injected into the peri-umbilicus cord
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Local anesthesia infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
The cumulative use of remifentanil and propofol during the operation.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 May 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, Principal investigator, Ethics Committee of Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820503
- Sponsor's protocol ID
- 2021-K036
- Status last verified
- Jan 2023
- First submitted
- 22 Mar 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05820503
- Acronym / sponsor ID
- 2021-K036
- Conditions
- Quality of Recovery
- Keywords
- Nerve block, Hernia in the groin, PAED score, FLACC score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R group :Ultrasound-guided lower abdominis rectus sheath block group | Experimental | Procedure: Ultrasound-guided lower abdominis rectus sheath blockUnder 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 | No intervention | –Do nothing with it |
| Local anesthesia infiltration Group | Experimental | Procedure: Local anesthesia infiltrationLocal anesthesia drugs were injected into the peri-umbilicus cord |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Preexisting neuropathy Coagulopathy Local skin infection Hepatic, renal, or cardiorespiratory failure Local anesthetic allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided lower abdominis rectus sheath blockUnder 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 or surgery | R group :Ultrasound-guided lower abdominis rectus sheath block group |
| Local anesthesia infiltrationLocal anesthesia drugs were injected into the peri-umbilicus cord | Procedure or surgery | Local anesthesia infiltration Group |
Primary outcome
Face Legs Activity Cry Consolability (FLACC) score
Time frame: 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.
Pediatric Anesthesia Emergence Delirium (PAED) scale
Time frame: Assessments were performed 5 minutes and 10 minutes after awakening, and the highest score was taken
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
1 secondary outcome
Cumulative use of anesthetic drugs during surgery
Time frame: Perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Zhang principal investigator
Ethics Committee of Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided lower abdominis rectus sheath block and Local anesthesia infiltration in people with Quality of Recovery, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face Legs Activity Cry Consolability (FLACC) score (time frame: 0,2, 4, 6, 12, 24, 36, and 48 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.