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Pain, PostoperativePhase 1/2NCT04926454

Efficacy of Adding Dexmedetomidine as an Adjuvant to Bupivacaine in TAP Block and Caudal Block

A Phase 1/2 study testing Dexmedetomidine in people with Pain, Postoperative, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study compares the efficacy of Dexmedetomidine as an adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block versus Caudal Block for post-operative analgesia in children undergoing congenital inguinal hernia repair especially to provide prolonged post-operative analgesia and decrease opioid… Read more about this study

Who is it for?
Ages 2 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
Dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
22 Sep 2020to 30 Oct 2021
Phase
Phase 1/2
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 2 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • age 2-12 years
  • Elective congenital inguinal hernia repair operation under general anaesthesia.
  • Physical Status: ASA I and II Patients after taking written and informed consent from the parents or care giver.

Who cannot join

  • Refusal of procedure or participation in the study by parents.
  • Physical status: ASA III or above.
  • Children undergoing bilateral lower abdominal surgeries.
  • Infection at site of injection.
  • Congenital anomaly of the spine.
  • History of developmental delay, neurological disease, skeletal deformities.
  • History or evidence of coagulopathy.
  • Allergies to drugs used (Bupivacaine 0.5%)( dexmedetomidine/prcedex)

Trial locations and contacts

1 site in 1 country.

Elsayed Mohamed Ali Mohamed, M.B.B.Ch contact

+201069907186

Sayedsharkawy66@gmail.com

Mohamed Mohamed kamal, Lecturer contact

+20 100 378 7898

dr_medo2000@hotmail.com

Egypt1 site, 1 recruiting
  • AinShams Hospitals

    Cairo, 02

    Elsayed Mohamed, M.B.B.Ch, +201069907186, Sayedsharkawy66@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block Versus Caudal Block for Post-operative Analgesia in Children Undergoing Congenital Inguinal Hernia Repair

This study compares the efficacy of Dexmedetomidine as an adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block versus Caudal Block for post-operative analgesia in children undergoing congenital inguinal hernia repair especially to provide prolonged post-operative analgesia and decrease opioid consumption.

Read the detailed description

Inguinal hernia is the most common lower abdominal surgery of childhood. It results from a small sac that comes through the inguinal ring that is normally open during fetal life and closes around the time of birth. For reasons we don't understand, it does not close in some infants. This sac then makes a pathway for abdominal organs to come through the inguinal ring into the groin . In boys, the organ is usually a loop of bowel and in girls; it may be bowel or an ovary. In boys and girls, the hernia first appears as a bulge in the groin. It usually "pops out" when the child cries or strains. If only fluid comes through the inguinal ring into the sac, the problem is called a hydrocele. It is treated via a low transverse incision to repair the defect.

Postoperatively, patients experience somatosensory pain from the incision site and visceral irritation and discomfort .

The impact of painful experience on the young nervous system is so significant that long-term effects can occur, including a lowered pain tolerance for months after a pain-producing event however, the benefits of adequate analgesia include attenuation of the surgical stress response, decreased perioperative morbidity and improved outcome in certain types of surgery. Also effective pain control facilitates rehabilitation and accelerates recovery from surgery .

Regional anesthesia and analgesia techniques are commonly used to facilitate pain control during pediatric surgical practice, decrease parenteral opioids requirements and improve the quality of post-operative pain control and patient-parent satisfaction.

Caudal epidural anesthesia is considered the gold standard regional technique for pain management after pediatric pelvic and lower abdominal procedures because it blocks both somatic and visceral pain. The caudal block has a low complication rate (0.7 per 1000) , provides 4 to 6 hours of analgesia, and results in improved patient pain scores than in patients having general anesthesia alone .

An increased understanding of abdominal wall anatomy has led to the introduction of the transversus abdominis plane block (TAPB) for managing pain after lower abdominal surgery .TAPB provides reliable unilateral sensory block in the T10-L1 distribution with a single injection, and resulted in a significant decrease in postoperative pain scores and opioid requirements after major abdominal surgeries . Similar outcomes have been observed in pediatric studies, and analgesia after TAPB in pediatric patients is thought to last 10 to 15 hours .

The technique of TAP block has been found to be a safe and effective tool in a variety of general, gynaecological, and urological surgery, and it is suggested as part of the multimodal anaesthetic approach to enhance recovery after lower abdominal surgeries .

However, the duration of analgesia provided by these strategies is limited by the short duration of action of the local anesthetic .

Various adjuvants to local anesthetics have been investigated to improve the quality of block and duration of analgesia, including Dexmedetomidine, fentanyl, morphine, ketamine, midazolam, and magnesium.

Each of these adjuvants has side effects specific to the type and dose of adjuvant used. For instance, behavioral changes have been noted with the use of caudal ketamine, opioids are associated with risk of respiratory depression, and the neurotoxicity of midazolam is still controversial. Therefore, an ideal adjuvant that provides maximal analgesia with minimal side effects for these blocks is still a matter of contention.

Dexmedetomidine (DEX) is a highly selective α2-adrenoceptor agonist, possesses sedative, analgesic, anxiolytic, and anti-inflammatory properties . When administered in combination with local anesthetics in the epidural space, it has been shown to reduce postoperative analgesic requirements and have a significantly

Being tested
Dexmedetomidine
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Bupivacaine

    Patients will be monitored using standard monitoring (heart rate, non-invasive blood pressure, ECG and pulse oximetery) After the child is adequately anesthetized, intra-venous access with appropriate size cannula will be obtained Appropriate size LMA (2 and 2.5) will be inserted and patients will be allowed to breathe spontaneously.

    patients will receive 0.25% Bupivacaine (0.3ml/Kg) with 1 μg/kg dexmedetomidine After general anaesthesia

Study groups in NCT04926454
Study groupRoleWhat they receive
TAP blockExperimentalpatients will receive general anesthesia followed by Tap block at the end of the operation.
Receives: Drug: Dexmedetomidine
Caudal blockExperimentalpatients will receive general anesthesia followed by caudal block at the beginning of the operation.
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. When Dexmedetomidine is administered in combination with local anesthetics in the epidural space, it has been shown to reduce postoperative analgesic requirements and have a significantly analgesic effect"

    The primary outcome measures were the time to first analgesia (in minutes from the time of caudal (or) TAP block injection to first registration of modified VAS scale ≥3 at any point of time will receive paracetamol 10mg/kg orally

    Measured: Within 24 hours post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2021
  2. Study start22 Sep 2020
  3. Primary completion25 Oct 2021 (estimated)
  4. Study completion30 Oct 2021 (estimated)

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04926454
Sponsor's protocol ID
FMASU M S 484 / 2020
Status last verified
Jun 2021
First submitted
23 May 2021
Last updated
14 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dexmedetomidine in people with Pain, Postoperative, run by Ain Shams 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 3 inclusion and 8 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 14 Oct 2021. 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 combined 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elsayed Mohamed Ali Mohamed, M.B.B.Ch (+201069907186, Sayedsharkawy66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

When Dexmedetomidine is administered in combination with local anesthetics in the epidural space, it has been shown to reduce postoperative analgesic requirements and have a significantly analgesic effect" (time frame: Within 24 hours post operative). 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 14 Oct 2021.

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