Unilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal SurgeryNCT04539314
Unilateral Transversus Abdominis Plane Block in Pediatrics
A study testing Bupivacain, Dexmedetomidine o.5 μg and Dexmedetomidine 1 μg in people with Unilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal Surgery, run by Minia University at 1 site in Egypt.
Trial summary
the present study was designed to compare the efficacy and safety of two different doses of dexmedetomidine as an adjuvant to bupivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Unilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal Surgery
- What is being tested?
- Bupivacain, Dexmedetomidine o.5 μg and Dexmedetomidine 1 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 30 Dec 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA class I or II, aged from 1-7 years old undergoing any lower abdominal surgery that requires skin incision in one side of midline of the anterior abdominal wall
Who cannot join
- Participants refusing regional block and those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia and hepatic disease or enlargement in addition to those who required emergency procedures or operations that requires exploratory longitudinal midline incision were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine as an Adjuvant to Bupivacaine in Unilateral Transversus Abdominis Plane Block in Pediatrics
the present study was designed to compare the efficacy and safety of two different doses of dexmedetomidine as an adjuvant to bupivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery.
Read the detailed description
After insertion of venous access, all children received premedication in the form of atropine at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean arterial blood pressure was recorded after monitor attachment.
General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 s as tolerated, atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain muscle relaxation.
TAP block will be performed in All patients immediately after induction patients will be allocated randomly into three equal groups, 30 patients in each as the following.
Group 1 (control group) TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) Group 2 We will carry out TAP block using the same dose of bupivacaine in the control group plus dexmedetomidine 0.5 μg / kg as an adjuvant Group (3) In this participants dexmedetomidine in dose 1 μg / kg will be given as an adjuvant to the control dose of bupivacaine in the TAP block TAP block procedure With the patient in the supine position, the site of the ultrasound and needle entry was sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle located around the midaxillary line with the probe transverse to the abdomen. Anteriorly, the needle passes to come perpendicular to the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line. Then, the local anesthetic will be injected. (Al-Sadek et al.,2014).
The procedure will be performed immediately after induction of anesthesia by candidate anesthesiologist who is not aware of group allocation.
After completion of surgical procedure anesthesia will be discontinued, muscle relaxant reversed using atropine 0.02 mg/kg and 0.05 mg/kg of neostigmine, extubated, and transferred to PACU.
Parameters will be assessed
- Quality of analgesia will be assessed immediately postoperatively and then at 2, 4, 8, 12 and 24 h postoperatively using FLACC scale (face,leg,activity,cry and consolability).
Time to the first analgesic requirement will be recorded from immediately postoperative to the time of FLACC score >6. Acetaminophen (perfalgan) 15 mg/kg IV will be given as rescue analgesia for patients if FLACC score >6 and total dose of acetaminophen will be recorded.
- Hemodynamic data including heart rate (HR) and mean arterial blood pressure (MAP).
Intraoperative any increase in heart rate and or mean arterial blood pressure by more than 20% of baseline values in response to surgical stimulus or thereafter throughout the whole operation warranted administration of intravenous fentanyl (0.5 μg/kg).
- postoperative complication including postoperative hypotension or bradycardia (decrease in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting (PONV)
- length of hospital stays, and patients or parents' satisfaction assessed on a 5-point scale (Al-Sadek et al.,2014) 1-completely dissatisfied, 2-dissatisfied, 3-not satisfied nor dissatisfied, 4- satisfied 5-completely satisfied
- Being tested
- Bupivacain, Dexmedetomidine o.5 μg, Dexmedetomidine 1 μg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
We will carry out the TAP block using 0.5 ml/ kg bupivacaine 0.25%
Dexmedetomidine o.5 μgDrug
We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 0.5 μg / kg
Dexmedetomidine 1 μgDrug
We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 1 μg / kg
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) Receives: Drug: Bupivacain |
| Dexmedetomidine 0.5 μg group | Active comparator | TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 0.5 μg / kg as an adjuvant Receives: Drug: Dexmedetomidine o.5 μg |
| Dexmedetomidine 1 μg group | Active comparator | TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 1 μg / kg as an adjuvant Receives: Drug: Dexmedetomidine 1 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of analgesia
Quality of analgesia will be assessed by using FLACC scale (face,leg,activity,cry and consolability)
Measured: 24 hours after block
Secondary outcomes (2)
postoperative complication
postoperative complication including postoperative hypotension or bradycardia (decrease in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting (PONV)
Measured: For 24 hours after surgery
parents' satisfaction
parents' satisfaction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Aug 2019
- Primary completion26 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haidy salah mansour, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539314
- Sponsor's protocol ID
- 274:7/2019
- Status last verified
- Jul 2023
- First submitted
- 31 Aug 2020
- Last updated
- 1 Aug 2023
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjuvant to Bupivacaine in Unilateral Transversus Abdominis Plane Block in Pediatrics
- ClinicalTrials.gov ID
- NCT04539314
- Acronym / sponsor ID
- 274:7/2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 26 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 7 Sep 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.
the present study was designed to compare the efficacy and safety of two different doses of dexmedetomidine as an adjuvant to bupivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery.
Detailed description
After insertion of venous access, all children received premedication in the form of atropine at a dose of 0.01-0.02 mg/kg. Perioperative monitoring included continuous ECG, pulse oximetry and non-invasive arterial blood pressure. Baseline reading of heart rate, mean arterial blood pressure was recorded after monitor attachment.
General anesthesia will be induced using propofol 1.5-2.5 mg/kg over 20-30 s as tolerated, atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium 0.1 mg/kg supplements will be given to maintain muscle relaxation.
TAP block will be performed in All patients immediately after induction patients will be allocated randomly into three equal groups, 30 patients in each as the following.
Group 1 (control group) TAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) Group 2 We will carry out TAP block using the same dose of bupivacaine in the control group plus dexmedetomidine 0.5 μg / kg as an adjuvant Group (3) In this participants dexmedetomidine in dose 1 μg / kg will be given as an adjuvant to the control dose of bupivacaine in the TAP block TAP block procedure With the patient in the supine position, the site of the ultrasound and needle entry was sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle located around the midaxillary line with the probe transverse to the abdomen. Anteriorly, the needle passes to come perpendicular to the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line. Then, the local anesthetic will be injected. (Al-Sadek et al.,2014).
The procedure will be performed immediately after induction of anesthesia by candidate anesthesiologist who is not aware of group allocation.
After completion of surgical procedure anesthesia will be discontinued, muscle relaxant reversed using atropine 0.02 mg/kg and 0.05 mg/kg of neostigmine, extubated, and transferred to PACU.
Parameters will be assessed
- Quality of analgesia will be assessed immediately postoperatively and then at 2, 4, 8, 12 and 24 h postoperatively using FLACC scale (face,leg,activity,cry and consolability).
Time to the first analgesic requirement will be recorded from immediately postoperative to the time of FLACC score >6. Acetaminophen (perfalgan) 15 mg/kg IV will be given as rescue analgesia for patients if FLACC score >6 and total dose of acetaminophen will be recorded.
- Hemodynamic data including heart rate (HR) and mean arterial blood pressure (MAP).
Intraoperative any increase in heart rate and or mean arterial blood pressure by more than 20% of baseline values in response to surgical stimulus or thereafter throughout the whole operation warranted administration of intravenous fentanyl (0.5 μg/kg).
- postoperative complication including postoperative hypotension or bradycardia (decrease in MAP or HR by more than 20% of baseline value), postoperative nausea and vomiting (PONV)
- length of hospital stays, and patients or parents' satisfaction assessed on a 5-point scale (Al-Sadek et al.,2014) 1-completely dissatisfied, 2-dissatisfied, 3-not satisfied nor dissatisfied, 4- satisfied 5-completely satisfied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: BupivacainTAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) |
| Dexmedetomidine 0.5 μg group | Active comparator | Drug: Dexmedetomidine o.5 μgTAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 0.5 μg / kg as an adjuvant |
| Dexmedetomidine 1 μg group | Active comparator | Drug: Dexmedetomidine 1 μgTAP block will be performed using (0.5 ml/ kg bupivacaine 0.25%) plus dexmedetomidine 1 μg / kg as an adjuvant |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA class I or II, aged from 1-7 years old undergoing any lower abdominal surgery that requires skin incision in one side of midline of the anterior abdominal wall
Key exclusion criteria (1 listed)
- Participants refusing regional block and those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia and hepatic disease or enlargement in addition to those who required emergency procedures or operations that requires exploratory longitudinal midline incision were excluded from the study
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 |
|---|---|---|
| BupivacainWe will carry out the TAP block using 0.5 ml/ kg bupivacaine 0.25% | Drug | Control group |
| Dexmedetomidine o.5 μgWe will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 0.5 μg / kg | Drug | Dexmedetomidine 0.5 μg group |
| Dexmedetomidine 1 μgWe will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 1 μg / kg | Drug | Dexmedetomidine 1 μg group |
Primary outcome
Quality of analgesia
Time frame: 24 hours after block
Quality of analgesia will be assessed by using FLACC scale (face,leg,activity,cry and consolability)
2 secondary outcomes
postoperative complication
Time frame: For 24 hours after surgery
parents' satisfaction
Time frame: 24 hours
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 1 Aug 2023.
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 Bupivacain, Dexmedetomidine o.5 μg and Dexmedetomidine 1 μg in people with Unilateral TAP Block in Pediatric Patients Undergoing Lower Abdominal Surgery, run by Minia 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 1 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: finished, as of the sponsor's last update on 1 Aug 2023. 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.
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?
Quality of analgesia (time frame: 24 hours after block). 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 1 Aug 2023.