Postoperative PainNCT05737394
Lap-guided vs Us-guided TAP Block in Pediatric Laparoscopy
A study testing Laparoscopic-guided TAP Block and Ultrasound-guided TAP Block in people with Postoperative Pain, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
Trial summary
Transversus Abdominis Plane (TAP) block is commonly used to control pain in laparoscopic procedures. It is usually administered with ultrasound guide but it can be also administered with laparoscopic assistance under direct visualization. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Laparoscopic-guided TAP Block and Ultrasound-guided TAP Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 31 Dec 2024
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age<= 18 yrs
- Elective or urgent laparoscopic surgical procedures including hernia repair, appendectomy, cholecystectomy, piloromyotomy, Nissen fundoplication, varicocelectomy
- ASA Status I and II
Who cannot join
- absence of parental consent
- ASA Status III-VI
- Presence of neurological disability affecting spontaneous mobility
- Previous surgical procedures on the abdominal wall (e.g. gastroschisis repair)
- Foreseen surgical duration bigger than 4 hours
- Conversion to laparotomy
- Use of concomitant other regional anesthesia technique (e.g. neuraxial or peripheral)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vittore Buzzi Children's Hospital
Milan, 20154
Anna Camporesi, MD, +393355793744, anna.camporesi@asst-fbf-sacco.it
Ugo Maria Pierucci, MD, ugomaria.pierucci@asst-fbf-sacco.it
About this study
Official title: Laparoscopy-guided Versus Ultrasound-guided Transversus Abdominis Plane (TAP) Block in Pediatric Laparoscopy: a Randomized, Controlled Trial
Transversus Abdominis Plane (TAP) block is commonly used to control pain in laparoscopic procedures. It is usually administered with ultrasound guide but it can be also administered with laparoscopic assistance under direct visualization.
Aim of the present study is determining if the lap-assisted TAP is superior to the us-guided TAP Block in pain control in the immediate postoperative phase as well at 1 and 6 hours post surgery.
Read the detailed description
Although pain in laparoscopic procedures has been demonstrated to be inferior to that of laparotomic ones, it is still produced because of rapid distension of peritoneum, visceral manipulation, irritation and traction of vessels and phrenic nerves, presence of residual gas and inflammatory mediators.
Analgesia can be achieved with multimodal techniques, which include oral or intravenous drugs as well as loco-regional anesthesia techniques.
The abdominal wall has three muscle layers: external and internal obliques, and transversus abdominis. They are innervated by mixed somatic nerves that course between the transversus abdominis and the internal oblique muscles.
Transversus Abdominis Plane Block is a regional analgesia technique which consists of injecting local anaesthetics between the transversus abdominis and internal oblique muscles, providing analgesia to the parietal peritoneum, skin and muscles of the anterior abdominal wall. It can provide benefit in both open and laparoscopic procedures and it is a safe technique, with a very low reported rate of complications.
Three major techniques are used to perform the Transversus Abdominis Plane (TAP) block-a landmark-based, an ultrasound-guided, and a surgical- placed TAP block.
Although the landmark technique is easy to perform, it might be complicated by inadvertent intraperitoneal organ damage.
Surgically administered Transversus Abdominis Plane (TAP) blocks have been performed by surgeons intraoperatively using the transperitoneal approach, accessing the Transversus Abdominis Plane (TAP) from the inside of the abdominal wall. Direct visualization of the needle and local anaesthetic spread may help to increase the accuracy as well as eliminating the risk of intraabdominal organ injury and is technically less difficult. It is however necessarily placed after incision and pneumoperitoneum establishment.
Ultrasound-guided Transversus Abdominis Plane (TAP) block on the other side can be performed prior to incision and pneumoperitoneum, thus avoiding nociception from the very beginning.
Aim of the present prospective, randomised, single center controlled study is to compare postoperative analgesic efficacy of laparo-assisted vs ultrasound-guided Transversus Abdominis Plane (TAP) block in pediatric laparoscopic procedures. Primary outcome will be the comparison of pain scores between groups upon arrival to Post-Anesthesia Care Unit (PACU).
Secondary outcomes are:
- pain scores at 1 and 6 hours after surgery
- general anesthesia requirements, as defined by Minimum Alveolar Concentration-hour (MAC_hour)
- intraoperative opiod consumption
- complication rates
- time to block completion
- Conditions
- Postoperative Pain
- Being tested
- Laparoscopic-guided TAP Block, Ultrasound-guided TAP Block
- Keywords
- tap block, laparoscopy, pediatric surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic-guided TAP BlockProcedure or surgery
Laparoscopically-assisted placement of block
Ultrasound-guided TAP BlockProcedure or surgery
Ultrasound-assisted placement of block
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy-guided TAP Block | Experimental | Patients will receive surgically-placed TAP block right after pneumoperitoneum induction and before Trocar insertion with levobupivacaine 0.25%, 0.5 ml/kg. Receives: Procedure: Laparoscopic-guided TAP Block |
| Ultrasound-guided TAP Block | Active comparator | Patients will receive ultrasound-guided TAP block performed after anesthetic induction and before surgical incision with levobupivacaine 0.25%, 0.5 ml/kg. Receives: Procedure: Ultrasound-guided TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores in PACU
Pain will be measured with FLACC scale (0-10 points; 0 no pain, 10 maximal pain) by operators blinded to the TAP technique
Measured: Post-Anesthesia Care Unit - immediately after end of surgery
Secondary outcomes (4)
Pain scores at 1 and 6 hours post-op
Comparison of pain scores measured with FLACC scale (0-10 points; 0 no pain, 10 maximal pain)by operators blinded to the TAP technique
Measured: first 6 hours post - op
Intraoperative opioids requirements
Comparison of need for additional boluses of intraoperative opioids if HR raises more than 10% of baseline
Measured: Intraoperative
General anesthetic requirements
Comparison of MAC-hour in the two groups
Measured: Intraoperative
Time to Block completion
Comparison of time needed to place the block between two groups
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jun 2024 (estimated)
- Primary completion28 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vittore Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Camporesi, Vittore Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737394
- Sponsor's protocol ID
- 2022/ST/264
- Status last verified
- May 2024
- First submitted
- 9 Feb 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopy-guided Versus Ultrasound-guided Transversus Abdominis Plane (TAP) Block in Pediatric Laparoscopy: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05737394
- Acronym / sponsor ID
- 2022/ST/264
- Conditions
- Postoperative Pain
- Keywords
- tap block, laparoscopy, pediatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Vittore Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 28 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 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.
Transversus Abdominis Plane (TAP) block is commonly used to control pain in laparoscopic procedures. It is usually administered with ultrasound guide but it can be also administered with laparoscopic assistance under direct visualization.
Aim of the present study is determining if the lap-assisted TAP is superior to the us-guided TAP Block in pain control in the immediate postoperative phase as well at 1 and 6 hours post surgery.
Detailed description
Although pain in laparoscopic procedures has been demonstrated to be inferior to that of laparotomic ones, it is still produced because of rapid distension of peritoneum, visceral manipulation, irritation and traction of vessels and phrenic nerves, presence of residual gas and inflammatory mediators.
Analgesia can be achieved with multimodal techniques, which include oral or intravenous drugs as well as loco-regional anesthesia techniques.
The abdominal wall has three muscle layers: external and internal obliques, and transversus abdominis. They are innervated by mixed somatic nerves that course between the transversus abdominis and the internal oblique muscles.
Transversus Abdominis Plane Block is a regional analgesia technique which consists of injecting local anaesthetics between the transversus abdominis and internal oblique muscles, providing analgesia to the parietal peritoneum, skin and muscles of the anterior abdominal wall. It can provide benefit in both open and laparoscopic procedures and it is a safe technique, with a very low reported rate of complications.
Three major techniques are used to perform the Transversus Abdominis Plane (TAP) block-a landmark-based, an ultrasound-guided, and a surgical- placed TAP block.
Although the landmark technique is easy to perform, it might be complicated by inadvertent intraperitoneal organ damage.
Surgically administered Transversus Abdominis Plane (TAP) blocks have been performed by surgeons intraoperatively using the transperitoneal approach, accessing the Transversus Abdominis Plane (TAP) from the inside of the abdominal wall. Direct visualization of the needle and local anaesthetic spread may help to increase the accuracy as well as eliminating the risk of intraabdominal organ injury and is technically less difficult. It is however necessarily placed after incision and pneumoperitoneum establishment.
Ultrasound-guided Transversus Abdominis Plane (TAP) block on the other side can be performed prior to incision and pneumoperitoneum, thus avoiding nociception from the very beginning.
Aim of the present prospective, randomised, single center controlled study is to compare postoperative analgesic efficacy of laparo-assisted vs ultrasound-guided Transversus Abdominis Plane (TAP) block in pediatric laparoscopic procedures. Primary outcome will be the comparison of pain scores between groups upon arrival to Post-Anesthesia Care Unit (PACU).
Secondary outcomes are:
- pain scores at 1 and 6 hours after surgery
- general anesthesia requirements, as defined by Minimum Alveolar Concentration-hour (MAC_hour)
- intraoperative opiod consumption
- complication rates
- time to block completion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy-guided TAP Block | Experimental | Procedure: Laparoscopic-guided TAP BlockPatients will receive surgically-placed TAP block right after pneumoperitoneum induction and before Trocar insertion with levobupivacaine 0.25%, 0.5 ml/kg. |
| Ultrasound-guided TAP Block | Active comparator | Procedure: Ultrasound-guided TAP BlockPatients will receive ultrasound-guided TAP block performed after anesthetic induction and before surgical incision with levobupivacaine 0.25%, 0.5 ml/kg. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age<= 18 yrs
- Elective or urgent laparoscopic surgical procedures including hernia repair, appendectomy, cholecystectomy, piloromyotomy, Nissen fundoplication, varicocelectomy
- ASA Status I and II
Key exclusion criteria (7 listed)
- absence of parental consent
- ASA Status III-VI
- Presence of neurological disability affecting spontaneous mobility
- Previous surgical procedures on the abdominal wall (e.g. gastroschisis repair)
- Foreseen surgical duration bigger than 4 hours
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 |
|---|---|---|
| Laparoscopic-guided TAP BlockLaparoscopically-assisted placement of block | Procedure or surgery | Laparoscopy-guided TAP Block |
| Ultrasound-guided TAP BlockUltrasound-assisted placement of block | Procedure or surgery | Ultrasound-guided TAP Block |
Primary outcome
Pain scores in PACU
Time frame: Post-Anesthesia Care Unit - immediately after end of surgery
Pain will be measured with FLACC scale (0-10 points; 0 no pain, 10 maximal pain) by operators blinded to the TAP technique
4 secondary outcomes
Pain scores at 1 and 6 hours post-op
Time frame: first 6 hours post - op
Intraoperative opioids requirements
Time frame: Intraoperative
General anesthetic requirements
Time frame: Intraoperative
Time to Block completion
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic-guided TAP Block and Ultrasound-guided TAP Block in people with Postoperative Pain, run by Vittore Buzzi Children's Hospital 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 10 May 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 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?
Contact Anna Camporesi, M.D. (+393355793744, anna.camporesi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores in PACU (time frame: Post-Anesthesia Care Unit - immediately after end of surgery). 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 10 May 2024.