Postoperative PainPhase 2NCT02723487
Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery
A Phase 2 study testing Bupivacaine 0.125% and Bupivacaine 0.25% in people with Postoperative Pain, run by Abdelrady S Ibrahim, MD at 1 site in Egypt.
Trial summary
The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 1 year to 5 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine 0.125% and Bupivacaine 0.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Oct 2017
- Phase
- Phase 2
- 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 1 year to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II physical status patients.
- Genders Eligible for Study :male.
- All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
- Duration of Laparoscopic procedure not exceeding 90 minutes.
- Written informed consent from parent of guardian .
Who cannot join
- Sensitivities to local anesthetics.
- Significant renal, liver, or cardiac disease.
- Surgery requiring an open procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery
The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.
Read the detailed description
A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia.
After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles.
After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side .
Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg.
The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine 0.125%, Bupivacaine 0.25%
- Keywords
- TAP block, pediatric, Laparoscopic, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.125%Drug
Also called Plain marcaine
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.
Bupivacaine 0.25%Drug
Also called Plain marcaine
Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Control |
| Group B | Active comparator | patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side. Receives: Drug: Bupivacaine 0.125% |
| Group C | Active comparator | patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side. Receives: Drug: Bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Children's Hospital Eastern Ontario Pain Scale
Measured: 12 hours postoperative
Secondary outcomes (6)
Total intraoperative fentanyl consumption
Microgram (ug)
Measured: 12 hours postoperative
number of participants with incidence of nausea
number of patients
Measured: 12 hours postoperative
number of participants with incidence of hematoma
number of patients
Measured: 12 hours postoperative
number of participants with incidence of infection
number of patients
Measured: 12 hours postoperative
Total postoperative paracetamol consumption
Milligram (mg)
Measured: 12 hours postoperative
Number of participants with incidence of vomiting
number of patients
Measured: 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdelrady S Ibrahim, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Abdelrady s Ibrahim, MD, Principal investigator, Assistant profossor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723487
- Sponsor's protocol ID
- 17100390
- Status last verified
- Dec 2017
- First submitted
- 14 Mar 2016
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Long JB, Birmingham PK, De Oliveira GS Jr, Schaldenbrand KM, Suresh S. Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database. Anesth Analg. 2014 Aug;119(2):395-399. doi: 10.1213/ANE.0000000000000284.
PubMed 24918899
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02723487
- Acronym / sponsor ID
- 17100390
- Conditions
- Postoperative Pain
- Keywords
- TAP block, pediatric, Laparoscopic, postoperative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abdelrady S Ibrahim, MDUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Mar 2016 (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.
The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.
Detailed description
A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia.
After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles.
After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side .
Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg.
The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Control |
| Group B | Active comparator | Drug: Bupivacaine 0.125%patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side. |
| Group C | Active comparator | Drug: Bupivacaine 0.25%patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ASA I-II physical status patients.
- Genders Eligible for Study :male.
- All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
- Duration of Laparoscopic procedure not exceeding 90 minutes.
- Written informed consent from parent of guardian .
Key exclusion criteria (3 listed)
- Sensitivities to local anesthetics.
- Significant renal, liver, or cardiac disease.
- Surgery requiring an open procedure
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 |
|---|---|---|
| Bupivacaine 0.125%Also: Plain marcainePatients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side. | Drug | Group B |
| Bupivacaine 0.25%Also: Plain marcainePatients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side. | Drug | Group C |
Primary outcome
pain score
Time frame: 12 hours postoperative
Children's Hospital Eastern Ontario Pain Scale
6 secondary outcomes
Total intraoperative fentanyl consumption
Time frame: 12 hours postoperative
number of participants with incidence of nausea
Time frame: 12 hours postoperative
number of participants with incidence of hematoma
Time frame: 12 hours postoperative
number of participants with incidence of infection
Time frame: 12 hours postoperative
Total postoperative paracetamol consumption
Time frame: 12 hours postoperative
Number of participants with incidence of vomiting
Time frame: 12 hours postoperative
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 8 Dec 2017.
- Background: PubMed 24918899Long JB, Birmingham PK, De Oliveira GS Jr, Schaldenbrand KM, Suresh S. Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database. Anesth Analg. 2014 Aug;119(2):395-399. doi: 10.1213/ANE.0000000000000284.
- Individual participant dataSharing planned: Undecided
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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.
Abdelrady s Ibrahim, MD principal investigator
Assistant profossor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine 0.125% and Bupivacaine 0.25% in people with Postoperative Pain, run by Abdelrady S Ibrahim, MD at 1 site in Egypt.
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 5 inclusion and 3 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 8 Dec 2017. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
pain score (time frame: 12 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723487, which also lists 1 linked publication.
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 8 Dec 2017.