Postoperative PainPhase 4TAPNCT00970086
Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery
A Phase 4 study testing Bupivacain/levobupivacaine in people with Postoperative Pain and Reaction; Anesthesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
For surgery in the region of the lower abdominal wall the administration of local anesthetic drugs in the epidural space via the caudal route is the preferentially used technique since several decades. The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve blockade. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Postoperative Pain, Reaction; Anesthesia
- What is being tested?
- Bupivacain/levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2009to Nov 2010
- Phase
- Phase 4
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children aged 2 - 8 years
- physical status classification system (ASA) score I or II
- Undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy)
Who cannot join
- Hypersensitivity to Levobupivacaine
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Childrens Hospital of both Basel
Basel, Basel, 4005
About this study
Official title: Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Inguinal Surgical Procedures: How Does it Compare With the "Gold Standard" Caudal Blockade
For surgery in the region of the lower abdominal wall the administration of local anesthetic drugs in the epidural space via the caudal route is the preferentially used technique since several decades.
The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve blockade. The aim of this study is to evaluate potential differences in the effectiveness of postoperative analgesia and to test the hypotheses that the duration of pain relieve ist prolonged after a TAP block when compared with an epidural technique.
Read the detailed description
Caudal block (CB) is the gold standard technique for analgesia in children undergoing surgical interventions in the groin.
Although the efficacy and the safety of this technique is high, nonetheless, there are several caveats such as unwarranted motor blockade of the lower limbs and disturbances of the bladder function, potentially resulting in delayed demission in the ambulatory setting. The effect of the blockade wears off within 4-5h post-block, making the administration of additional pain medication necessary.
Peripheral nerve blockades (PNB) are an alternative to CB and have a prolonged duration of the analgesic effect. More recently, an alternative method to block neural structures which innervate lower abdominal wall has been described; the transverse abdominal plane block. The ultrasound guided technique improves the safety of margin. However, although this new technique seems to offer substantial advantages so far only experience from small case series are available. In particular, the TAP block has not been compared in a systematic trial with the "gold standard", the caudal block.
- Conditions
- Postoperative Pain, Reaction; Anesthesia
- Being tested
- Bupivacain/levobupivacaine
- Keywords
- measure of postoperative pain, children undergoing groin 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.
Bupivacain/levobupivacaineDrug
Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%.
Transversus abdominal plane block: Identification of the anatomical structures by the ultrasound technique, administration of 0.4ml/kg levobupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominal plane block | Experimental | Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%.
Transversus abdominal plane block: Identification of the anatomical structures with ultrasound, insertion of the stimuplex needle G22, 50mm, in an in-plane approach and administration of 0.4ml/kg levobupivacaine 0.25%. Receives: Drug: Bupivacain/levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale.
Measured: 4 h postoperative and morning, 1 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Groin surgery was changed to a laparoscopic technique; recruitable patients ceased.
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.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Erb, PD, Principal investigator, University Childrens Hospital of both Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970086
- Sponsor's protocol ID
- UKBB_ANA_TAP
- Acronym
- TAP
- Status last verified
- Dec 2015
- First submitted
- 25 Aug 2009
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Inguinal Surgical Procedures: How Does it Compare With the "Gold Standard" Caudal Blockade
- ClinicalTrials.gov ID
- NCT00970086
- Acronym / sponsor ID
- TAP / UKBB_ANA_TAP
- Conditions
- Postoperative Pain, Reaction; Anesthesia
- Keywords
- measure of postoperative pain, children undergoing groin surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Groin surgery was changed to a laparoscopic technique; recruitable patients ceased.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Sep 2009 (estimated)
- 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.
For surgery in the region of the lower abdominal wall the administration of local anesthetic drugs in the epidural space via the caudal route is the preferentially used technique since several decades.
The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve blockade. The aim of this study is to evaluate potential differences in the effectiveness of postoperative analgesia and to test the hypotheses that the duration of pain relieve ist prolonged after a TAP block when compared with an epidural technique.
Detailed description
Caudal block (CB) is the gold standard technique for analgesia in children undergoing surgical interventions in the groin.
Although the efficacy and the safety of this technique is high, nonetheless, there are several caveats such as unwarranted motor blockade of the lower limbs and disturbances of the bladder function, potentially resulting in delayed demission in the ambulatory setting. The effect of the blockade wears off within 4-5h post-block, making the administration of additional pain medication necessary.
Peripheral nerve blockades (PNB) are an alternative to CB and have a prolonged duration of the analgesic effect. More recently, an alternative method to block neural structures which innervate lower abdominal wall has been described; the transverse abdominal plane block. The ultrasound guided technique improves the safety of margin. However, although this new technique seems to offer substantial advantages so far only experience from small case series are available. In particular, the TAP block has not been compared in a systematic trial with the "gold standard", the caudal block.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transversus abdominal plane block | Experimental | Drug: Bupivacain/levobupivacaineCaudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%. Transversus abdominal plane block: Identification of the anatomical structures with ultrasound, insertion of the stimuplex needle G22, 50mm, in an in-plane approach and administration of 0.4ml/kg levobupivacaine 0.25%. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female children aged 2 - 8 years
- physical status classification system (ASA) score I or II
- Undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy)
Key exclusion criteria (1 listed)
- Hypersensitivity to Levobupivacaine
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 |
|---|---|---|
| Bupivacain/levobupivacaineCaudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%. Transversus abdominal plane block: Identification of the anatomical structures by the ultrasound technique, administration of 0.4ml/kg levobupivacaine 0.25%. | Drug | transversus abdominal plane block |
Primary outcome
Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale.
Time frame: 4 h postoperative and morning, 1 day postoperative
Results and safety
The study was stopped early (reason given: Groin surgery was changed to a laparoscopic technique; recruitable patients ceased.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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.
Thomas Erb, PD principal investigator
University Childrens Hospital of both Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacain/levobupivacaine in people with Postoperative Pain and Reaction; Anesthesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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: stopped early, as of the sponsor's last update on 3 Dec 2015. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Groin surgery was changed to a laparoscopic technique; recruitable patients ceased.). 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?
Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale. (time frame: 4 h postoperative and morning, 1 day postoperative). 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 3 Dec 2015.