AppendectomyNCT04294537
TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: a Pilot Study
A study testing TAP Block, LIA local infiltration and General anesthesia in people with Appendectomy and Laparoscopy, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial summary
Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Appendectomy, Laparoscopy, Anesthesia, Conduction
- What is being tested?
- TAP Block, LIA local infiltration and General anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2020to 30 May 2020
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged between 3 and 16 years, candidates for laparoscopic appendectomy for suspected acute appendicitis.
- ASA physical status Class I and II
- Informed consent signed by parents / legal guardians
Who cannot join
- severe obesity (BMI> 95th percentile for age and weight)
- perforated appendicitis
- paralytic ileum
- non-stabilized neuropathies
- allergy to local anesthetics or analgesics used in the study protocol.
- patients on chronic opiate treatment
- need for perioperative hospitalization in intensive care with sedation and / or mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Day Surgery Ospedale di Circolo Varese
Varese, VA, 21100
About this study
Official title: TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: Prospective Randomized Study
Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children
Read the detailed description
Laparoscopic appendectomy is one of the main emergency surgical procedures performed in children.
The available local anesthesia techniques include wound infiltration or "wall" blocks such as the TAP (transversus abdominis plane) block.
The greater evidence on the adult population suggests that both techniques are valid for pain control in the immediate postoperative period, although wall blocks can guarantee a more prolonged analgesic effect over time.
The evidence on the pediatric population, on the other hand, is less strong and sometimes conflicting: therefore, the objective of our study is to verify the efficacy of TAP block compared to wound infiltration in the control of postoperative pain after appendectomy in pediatric patients.
- Conditions
- Appendectomy, Laparoscopy, Anesthesia, Conduction, Child, Preschool
- Being tested
- TAP Block, LIA local infiltration, General anesthesia, Postperative analgesia
- Keywords
- TAP Block, Wound Infiltration, Laparoscopic Appendectomy, Levobupivacaine, Pediatric Surgery, Pediatric Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlockProcedure or surgery
At the end of surgery patients will receive bilateral ultrasound-guided single-shot TAP block: 0,15% levobupivacaine 0,75 mg/kg per side will be injected between internal oblique and transveralis fascia
LIA local infiltrationProcedure or surgery
At the end of surgery 0,5% levobupivacaine 1.5 mg/kg, equally distributed between ports, injected in the skin and subcutaneous tissue during wound closure.
General anesthesiaProcedure or surgery
General anesthesia will be induced with fentanyl 1,5 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg; after intubation anesthesia will be mantained with sevoflurane (MAC 1).
30 minutes after induction will be administered paracetamol 15 mg/kg iv.
Postperative analgesiaDrug
During first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery.
In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | Bilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side. Receives: Procedure: TAP Block; Procedure: General anesthesia; Drug: Postperative analgesia |
| LIA - local wound infiltration | Active comparator | Wound infiltration with 0,5% levobupivacaine 1.5 mg/kg Receives: Procedure: LIA local infiltration; Procedure: General anesthesia; Drug: Postperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain at 2 hours
Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 2 hours after the end of the surgery.
Measured: 2 hours
Secondary outcomes (4)
Postoperative pain at 4-12-24 hours
Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 4 hours, 12 hours and 24 hours from the end of the surgery.
Measured: from 4 to 24 postoperative hours
Total opioid consumption
Differences in tramadol rescue use (expressed in mg/kg) in the TAP group compared to the LIA group
Measured: from 2 to 24 postoperative hours
time to first opioid analgesic rescue
Differences in the elapsed time before first request for tramadol rescue in the TAP group compared to the LIA group
Measured: from 2 to 24 postoperative hours
Side effects
Differences in the incidence of side effects depending on the anesthetic technique adopted
Measured: from 2 to 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start30 Mar 2020 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendectomyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294537
- Sponsor's protocol ID
- VARPON001
- Status last verified
- Mar 2020
- First submitted
- 9 Nov 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP Block or Wound Infiltration for Laparoscopic Pediatric Appendectomy: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04294537
- Acronym / sponsor ID
- VARPON001
- Conditions
- Appendectomy, Laparoscopy, Anesthesia, Conduction, Child, Preschool
- Keywords
- TAP Block, Wound Infiltration, Laparoscopic Appendectomy, Levobupivacaine, Pediatric Surgery, Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 4 Mar 2020 (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.
Effectiveness of the TAP block compared to wound infiltration in controlling pain after laparoscopic appendectomy in children
Detailed description
Laparoscopic appendectomy is one of the main emergency surgical procedures performed in children.
The available local anesthesia techniques include wound infiltration or "wall" blocks such as the TAP (transversus abdominis plane) block.
The greater evidence on the adult population suggests that both techniques are valid for pain control in the immediate postoperative period, although wall blocks can guarantee a more prolonged analgesic effect over time.
The evidence on the pediatric population, on the other hand, is less strong and sometimes conflicting: therefore, the objective of our study is to verify the efficacy of TAP block compared to wound infiltration in the control of postoperative pain after appendectomy in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Procedure: TAP Block, Procedure: General anesthesia, Drug: Postperative analgesiaBilateral ultrasound-guided single-shot TAP block with 0,15% levobupivacaine 0,75 mg/kg per side. |
| LIA - local wound infiltration | Active comparator | Procedure: LIA local infiltration, Procedure: General anesthesia, Drug: Postperative analgesiaWound infiltration with 0,5% levobupivacaine 1.5 mg/kg |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged between 3 and 16 years, candidates for laparoscopic appendectomy for suspected acute appendicitis.
- ASA physical status Class I and II
- Informed consent signed by parents / legal guardians
Key exclusion criteria (7 listed)
- severe obesity (BMI> 95th percentile for age and weight)
- perforated appendicitis
- paralytic ileum
- non-stabilized neuropathies
- allergy to local anesthetics or analgesics used in the study protocol.
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 |
|---|---|---|
| TAP BlockAt the end of surgery patients will receive bilateral ultrasound-guided single-shot TAP block: 0,15% levobupivacaine 0,75 mg/kg per side will be injected between internal oblique and transveralis fascia | Procedure or surgery | TAP block |
| LIA local infiltrationAt the end of surgery 0,5% levobupivacaine 1.5 mg/kg, equally distributed between ports, injected in the skin and subcutaneous tissue during wound closure. | Procedure or surgery | LIA - local wound infiltration |
| General anesthesiaGeneral anesthesia will be induced with fentanyl 1,5 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg; after intubation anesthesia will be mantained with sevoflurane (MAC 1). 30 minutes after induction will be administered paracetamol 15 mg/kg iv. | Procedure or surgery | LIA - local wound infiltration, TAP block |
| Postperative analgesiaDuring first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery. In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours. | Drug | LIA - local wound infiltration, TAP block |
Primary outcome
Postoperative pain at 2 hours
Time frame: 2 hours
Difference in pain severity (assessed by Wong Baker for under 8 year and visual analog scale dor older than 8) of TAP block goup compared to wound infiltration group 2 hours after the end of the surgery.
4 secondary outcomes
Postoperative pain at 4-12-24 hours
Time frame: from 4 to 24 postoperative hours
Total opioid consumption
Time frame: from 2 to 24 postoperative hours
time to first opioid analgesic rescue
Time frame: from 2 to 24 postoperative hours
Side effects
Time frame: from 2 to 24 postoperative hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP Block, LIA local infiltration and General anesthesia in people with Appendectomy and Laparoscopy, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. 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 Italy. 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?
Results are not available in the source record.
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?
Postoperative pain at 2 hours (time frame: 2 hours). 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 4 Mar 2020.