Lower Abdominal SurgeryPhase 1NCT02398123
Transversus Abdominis Plane Versus Caudal Block for Pediatrics
A Phase 1 study testing Transversus abdominis plane block, Caudal block and Bupivacaine in people with Lower Abdominal Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
The transversus abdominis plane (TAP) block is a relatively simple technique that provides myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in the prevention and treatment of parietal postoperative pain. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Lower Abdominal Surgery
- What is being tested?
- Transversus abdominis plane block, Caudal block and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Jul 2015
- Phase
- Phase 1
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children
- Lower abdominal surgery
Who cannot join
- Allergy to study medications
- Contraindications to caudal block
- Contraindications to transversus abdominis block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane (TAP) Blocks Versus Caudal Block for Postoperative Pain Control After Unilateral Lower Abdominal Surgeries in Pediatrics: A Prospective, Randomized Study.
The transversus abdominis plane (TAP) block is a relatively simple technique that provides myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in the prevention and treatment of parietal postoperative pain.
Initial experience with ultrasound TAP block demonstrated efficacy of the echo guided technique in different surgical procedures such as cesarean section, appendicectomy, laparoscopic cholecystectomy, infra umbilical surgery in adult and pediatric patients. Recently published clinical trials suggest that TAP block may represents an effective alternative to epidural anesthesia but further studies in larger population are necessary.
Transversus-abdominis plane (TAP) block was found to increase analgesic consumption low thoracic-epidural analgesia (TEA) in ischemic heart disease patients after abdominal laparotomy (2). Others found comparable results between continuous transversus abdominis plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction after abdominal surgery(3). The TAP block affords effective analgesia with opioid sparing effects, technical simplicity, and long duration of action. Some disadvantages include the need for bilateral block for midline incisions and absence of effectiveness for visceral pain (4). TAP block has been associated with good pain relief and decreased intraoperative and postoperative opioids requirements after laparoscopic surgery (5). The analgesic efficacy of the TAP block has been demonstrated in prospective randomized trials compared with placebo, in different surgical procedures such as abdominal surgery, hysterectomy, retro pubic prostatectomy, Caesarean section, laparoscopic cholecystectomy, and appendicectomy (6, 7, 8, 9, 5 and 10 respectively). All these studies have reported superiority of the TAP block in terms of reduction in visual analogue scale scores and morphine consumption. In this study the investigators try to compare Transversus Abdominis Plane (TAP) blocks versus caudal block for postoperative pain control after lower abdominal surgeries in pediatrics.
Read the detailed description
Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study.
Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 33% oxygen and 66% nitrous oxide; 1ug/kg fentanyl is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).
Anesthesia would be maintained with 2% sevoflurane and nitrous oxide.
An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose5% (1:1) solution was infused in a dose of 12 ml/ kg /h.
Children were transferred from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.
Patients received rectal paracetamol 15 mg/ kg every 6 hours. Tramadol 1mg/kg is rescue analgesic.
- Conditions
- Lower Abdominal Surgery
- Being tested
- Transversus abdominis plane block, Caudal block, Bupivacaine
- Keywords
- Transversus Abdominis Plane, caudal block, postoperative pain, children
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockOther
Children who received transversus aAbdominis plane block with 0.25% bupivacaine with epinephrine 1 mL/kg guided by ultrasound
Caudal blockOther
Children who received caudal 0.25% bupivacaine 1 mL/kg
BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis plane block | Active comparator | Transversus Abdominis Plane block Receives: Other: Transversus abdominis plane block; Drug: Bupivacaine |
| Caudal block | Placebo comparator | Caudal block Receives: Other: Caudal block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first analgesic request
By investigators until hospital discharge, then through telephone interview with parents after that
Measured: 24 hours after surgery
Secondary outcomes (4)
Total opioid consumption
By investigators until hospital discharge, then through telephone interview with parents after that
Measured: 24 hours after surgery
Sedation level
Sedation level would be evaluated using a four-point sedation scale, 0=eyes open spontaneously, 1=eyes open to speech, 2=eyes open when shaken, 3=un arousable.
Measured: 12 hours after surgery
Parent satisfaction scores
By investigators until hospital discharge, then through telephone interview with parents after that
Measured: 24 hours after surgery
Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS),
By investigators until hospital discharge, then through telephone interview with parents after that
Measured: 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 18 h, 24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed R El Tahan, Mansoura University
- Investigators
- Alaa Eldeeb, MD, Study chair, Associate Professor of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398123
- Sponsor's protocol ID
- MUH-Feb-2015
- Status last verified
- Sep 2015
- First submitted
- 16 Mar 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Blocks Versus Caudal Block for Postoperative Pain Control After Unilateral Lower Abdominal Surgeries in Pediatrics: A Prospective, Randomized Study.
- ClinicalTrials.gov ID
- NCT02398123
- Acronym / sponsor ID
- MUH-Feb-2015
- Conditions
- Lower Abdominal Surgery
- Keywords
- Transversus Abdominis Plane, caudal block, postoperative pain, children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Mar 2015 (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 transversus abdominis plane (TAP) block is a relatively simple technique that provides myocutaneous anesthesia that, as part of a multimodal analgesic treatment, may be useful in the prevention and treatment of parietal postoperative pain.
Initial experience with ultrasound TAP block demonstrated efficacy of the echo guided technique in different surgical procedures such as cesarean section, appendicectomy, laparoscopic cholecystectomy, infra umbilical surgery in adult and pediatric patients. Recently published clinical trials suggest that TAP block may represents an effective alternative to epidural anesthesia but further studies in larger population are necessary.
Transversus-abdominis plane (TAP) block was found to increase analgesic consumption low thoracic-epidural analgesia (TEA) in ischemic heart disease patients after abdominal laparotomy (2). Others found comparable results between continuous transversus abdominis plane technique and epidural analgesia in regard to pain, analgesic use and satisfaction after abdominal surgery(3). The TAP block affords effective analgesia with opioid sparing effects, technical simplicity, and long duration of action. Some disadvantages include the need for bilateral block for midline incisions and absence of effectiveness for visceral pain (4). TAP block has been associated with good pain relief and decreased intraoperative and postoperative opioids requirements after laparoscopic surgery (5). The analgesic efficacy of the TAP block has been demonstrated in prospective randomized trials compared with placebo, in different surgical procedures such as abdominal surgery, hysterectomy, retro pubic prostatectomy, Caesarean section, laparoscopic cholecystectomy, and appendicectomy (6, 7, 8, 9, 5 and 10 respectively). All these studies have reported superiority of the TAP block in terms of reduction in visual analogue scale scores and morphine consumption. In this study the investigators try to compare Transversus Abdominis Plane (TAP) blocks versus caudal block for postoperative pain control after lower abdominal surgeries in pediatrics.
Detailed description
Children aged 1-7 years undergoing lower abdominal surgeries would be recruited in this randomized study.
Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 33% oxygen and 66% nitrous oxide; 1ug/kg fentanyl is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).
Anesthesia would be maintained with 2% sevoflurane and nitrous oxide.
An increase in blood pressure or heart rate by more than 15% from preoperative value was defined as insufficient analgesia and was treated with fentanyl 0.5 µ/kg. Saline dextrose5% (1:1) solution was infused in a dose of 12 ml/ kg /h.
Children were transferred from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.
Patients received rectal paracetamol 15 mg/ kg every 6 hours. Tramadol 1mg/kg is rescue analgesic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis plane block | Active comparator | Other: Transversus abdominis plane block, Drug: BupivacaineTransversus Abdominis Plane block |
| Caudal block | Placebo comparator | Other: Caudal block, Drug: BupivacaineCaudal block |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children
- Lower abdominal surgery
Key exclusion criteria (3 listed)
- Allergy to study medications
- Contraindications to caudal block
- Contraindications to transversus abdominis block
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 |
|---|---|---|
| Transversus abdominis plane blockChildren who received transversus aAbdominis plane block with 0.25% bupivacaine with epinephrine 1 mL/kg guided by ultrasound | Other | Transversus abdominis plane block |
| Caudal blockChildren who received caudal 0.25% bupivacaine 1 mL/kg | Other | Caudal block |
| Bupivacaine | Drug | Caudal block, Transversus abdominis plane block |
Primary outcome
Time for first analgesic request
Time frame: 24 hours after surgery
By investigators until hospital discharge, then through telephone interview with parents after that
4 secondary outcomes
Total opioid consumption
Time frame: 24 hours after surgery
Sedation level
Time frame: 12 hours after surgery
Parent satisfaction scores
Time frame: 24 hours after surgery
Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS),
Time frame: 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 18 h, 24 h after surgery
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 16 Sep 2015.
Related trials for Lower Abdominal Surgery
Recruiting
Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries
Bilateral Inguinal Hernia Repair, Open Upper Abdominal Surgeries
RecruitingPhase 4
Dexamethasone and Duration of Spinal Anesthesia
Dexamethasone, Spinal Anesthesia
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
RecruitingObservational study
Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years
Agitation, Postoperative Agitation
RecruitingPhase 1/2
Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain
Acue Postoperative Pain
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.
Alaa Eldeeb, MD study chair
Associate Professor of Anesthesia and Surgical ICU, Mansoura University , Mansoura City, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transversus abdominis plane block, Caudal block and Bupivacaine in people with Lower Abdominal Surgery, run by Mansoura University 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 2 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 16 Sep 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 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Time for first analgesic request (time frame: 24 hours after 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 16 Sep 2015.