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Pain, PostoperativePhase 4NCT04700228

Comparison of Doses of Dexmedetomidine With Bupivacaine in Caudal Block for Duration of Analgesia in Paediatric Infraumblical Surgeries.

A Phase 4 study testing Bupivacaine Hydrochloride and Dexmedetomidine in people with Pain, Postoperative, run by Dr. Ruth K.M. Pfau Civil Hospital, Karachi at 1 site in Pakistan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Various methods are used to control post-operative pain among children. Amongst these methods, caudal block is one of the most favoured, prominent and dependable methods for providing reliable analgesia in surgeries below umbilicus. Read more about this study

Who is it for?
Ages 1 year to 6 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
Bupivacaine Hydrochloride and Dexmedetomidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
1 sitePakistan
Study dates
Feb 2021to Sep 2021
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 1 year to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • American Society of Anaesthesiologists (ASA) Status I and II
  • Aged between 1 to 6 years
  • Planned for below umbilicus elective surgery

Who cannot join

  • Refusal to consent by parent/guardian
  • Injection site infection
  • Coagulation disorders
  • Congenital abnormalities of lower spine and meninges
  • Anticipated difficult airway requiring endotracheal intubation and intermittent positive pressure ventilation
  • Prone position surgical procedures
  • Known drug allergy history

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Dr. Haris Chohan

    Karachi, Sindh, 75400

Other trials in Pakistan

About this study

Various methods are used to control post-operative pain among children. Amongst these methods, caudal block is one of the most favoured, prominent and dependable methods for providing reliable analgesia in surgeries below umbilicus.

This study is to compare two doses of Dexmedetomidine added as adjunct to local anaesthesia using reduced dose in caudal block for prolonging the duration of analgesia. Our secondary outcomes will include blood pressure, heart rate, urinary retention, nausea and vomiting in the paediatric population.

Read the detailed description

Pain is one the most underrated, misunderstood and often underdiagnosed field especially in children. Pain is an unpleasant feeling which is basically a subjective feeling, which in children is poorly expressed. Failure to control pain during childhood ultimately results in having chronic adverse effects which include altered sleep, eating habits and neuroendocrine responses and increased sensitivity to pain in the following pain episodes.

Successful postoperative pain management is one of the main pillars of anaesthesia. Regional Anaesthesia has gained a lot of popularity over the past few years in paediatrics. Approximately one-quarter of analgesic procedures currently performed on children are done by regional analgesic techniques. There are various methods that are being currently used to control post-operative pain among children. Amongst these methods, caudal block is one of the most favoured, prominent and dependable methods for providing reliable analgesia in surgeries below umbilicus. However, it has a drawback of being having a limited time of action when used as a single shot technique. This time limit can be increased significantly by the addition of different adjuvants along with local anaesthetic drugs in caudal block, which not only helps the anaesthesiologist in giving a better quality of anaesthesia and analgesia but it leads up to creating a desirable intraoperative environment for the surgeon as well. Better control over intraoperative and post-operative analgesia also helps the anaesthesiologist in giving reduced levels of anaesthesia which caused reduced amount of postoperative sedation as well.

Dexmedetomidine has a specific affinity for α2-adrenoreceptor having sedative and analgesic properties, which makes it an ideal adjuvant agent. The landmark ability of this adjuvant is that it causes minimal respiratory depression even at high dosages. A number of studies have been done until now that have proved successfully that dexmedetomidine can be used as an adjuvant in caudal block, in children, in enhancing post-operative analgesia. Although there is insufficient data available, various studies have demonstrated the dose of dexmedetomidine in Caudal Block ranging from 0.5 µg/kg to 2 µg/kg. According to an up to date review anaesthesia will last longer with dexmedetomidine as compared to morphine when used, as haemodynamics were found to be stable mostly when dexmedetomidine was used. However bradycardia was mostly related to a dose of 2 mcg/kg of dexmedetomidine. A study published in 2019 documented a decrease in heart rate, not requiring active management, in the dexmedetomidine group at a dose of 1mcg/kg.

Our objective is to compare two doses of Dexmedetomidine added as adjunct to local anaesthesia using reduced dose in caudal block for prolonging the duration of analgesia. Our secondary outcomes will include blood pressure, heart rate, urinary retention, nausea and vomiting in the paediatric population.

Patient meeting inclusion criteria visiting paediatric operating room will be inducted in the study. Informed and written consent will be taken from parents/guardian explained about the potential risk and benefits of study. Patients' demographic details like age, sex, and weight will be collected by filling the relevant proforma. A total of 162 patients will be divided into three equal groups randomly by lottery method. The observer and the anaesthesiologist who will induce the patient will be blinded regarding the group in which the patient will be placed.

Pre operatively, a detailed history, examination and related laboratory investigations will be seen as a part of hospital pre-operative assessment protocol. On arrival to operation theatre, monitors (SpO2, Pulse Oximeter, NIBP, pre cordial stethoscope and ECG) will be applied. Emergency drugs will be prepared already before the patient arrives in operation theatre. Anaesthesia will be induced with 100% oxygen and sevoflurane 8% using Jackson Rees Circuit. Once the desired depth of anaesthesia is achieved, I/V access will be taken. Propofol 3mg/kg and Nalbuphine 0.1mg/kg will be given and Sevoflurane will be set at 3%. LMA of desirable size will be placed. After this, patient would be placed in lateral position. Sufficient exposure would be done for Caudal Block. After taking all aseptic measures, Caudal Block procedure will be done with help of 23G needle after identifying the anatomical landmarks. Correction position of the needle will be confirmed by swoosh and whoosh test. On aspiration of the syringe if it is negative for CSF and blood, then one of the following drug combinations will be used for the caudal block.

Group C (control): 0.25% bupivacaine at a total volume of 0.5ml/kg Group BD1: 0.25% bupivacaine + 1mcg/kg dexmedetomidine at a total volume of 0.5ml/kg Group BD2: 0.25% bupivacaine + 0.5mcg/kg dexmedetomidine at a total volume of 0.5ml/kg After dressing the injection site, the patient will be turned supine. Vitals of the patient including heart rate, blood pressure, SpO2 and respiratory will be recorded before the induction of caudal block and there after every 10 minutes. Inadequate analgesia or unsuccessful block will be labelled if there would be a 20% increase in heart rate of the patient as compared to the baseline recording. If the caudal block is insufficient that case will not be included in the study. Hypotension and bradycardia will be recorded and treated with fluid bolus and atropine respectively. . The first surgical incision would be given 10 mins after the application of caudal block. After the completion of the surgery, inhalation gas will be closed and patient will be given 100% oxygen only. LMA will be removed once the patient is awake and the patient will be shifted to Post Anaesthesia Care Unit (PACU). Here patient's vitals will be monitored and pain will be assessed at 1, 2, 4, 6 and 12 hours after the application of caudal block using FLACC scale16. Time taken for the requirement of first rescue analgesia will also be recorded. Intravenous paracetamol 15mg/kg will be given if FLACC score is more than 4 at any of the above mentioned time. Secondary findings like heart rate, blood pressure, respiratory depression, urinary retention, nausea and vomiting will also be recorded.

Being tested
Bupivacaine Hydrochloride, Dexmedetomidine
Keywords
Postoperative pain, Regional Anaesthesia, Caudal Block, Dexmedetomidine, Infraumbilical surgeries
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 HydrochlorideDrug

    We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.

  • DexmedetomidineDrug

    We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.

Study groups in NCT04700228
Study groupRoleWhat they receive
Group CPlacebo comparator0.25% bupivacaine at a total volume of 0.5ml/kg.
Receives: Drug: Bupivacaine Hydrochloride
Group BD1Active comparator0.25% bupivacaine + 1mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.
Receives: Drug: Bupivacaine Hydrochloride; Drug: Dexmedetomidine
Group BD2Active comparator0.25% bupivacaine + 0.5mcg/kg dexmedetomidine at a total volume of 0.5ml/kg.
Receives: Drug: Bupivacaine Hydrochloride; Drug: Dexmedetomidine

What is being measured

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

  1. Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    Measured: 1 hour after caudal block

  2. Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    Measured: 2 hours after caudal block

  3. Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    Measured: 4 hours after caudal block

  4. Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    Measured: 6 hours after caudal block

  5. Duration of Analgesia

    Time period between administration of block until the time face, legs, activity, cry, consolability (FLACC) score reached ≥4

    Measured: 12 hours after caudal block

Secondary outcomes (15)
  1. Heart Rate (bradycardia)

    heart rate less than 60 beats/min for ages above 1 year.

    Measured: 1 hour after caudal block.

  2. Heart Rate (bradycardia)

    heart rate less than 60 beats/min for ages above 1 year.

    Measured: 2 hours after caudal block.

  3. Heart Rate (bradycardia)

    heart rate less than 60 beats/min for ages above 1 year.

    Measured: 4 hours after caudal block.

  4. Heart Rate (bradycardia)

    heart rate less than 60 beats/min for ages above 1 year.

    Measured: 6 hours after caudal block.

  5. Heart Rate (bradycardia)

    heart rate less than 60 beats/min for ages above 1 year.

    Measured: 12 hours after caudal block.

  6. Blood Pressure

    Decrease in systolic blood pressure < 25% from the baseline

    Measured: 1 hour after caudal block.

  7. Blood Pressure

    Decrease in systolic blood pressure < 25% from the baseline

    Measured: 2 hours after caudal block.

  8. Blood Pressure

    Decrease in systolic blood pressure < 25% from the baseline

    Measured: 4 hours after caudal block.

  9. Blood Pressure

    Decrease in systolic blood pressure < 25% from the baseline

    Measured: 6 hours after caudal block.

  10. Blood Pressure

    Decrease in systolic blood pressure < 25% from the baseline

    Measured: 12 hours after caudal block.

  11. Postoperative Respiratory Depression

    if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.

    Measured: 1 hour after caudal block.

  12. Postoperative Respiratory Depression

    if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.

    Measured: 2 hours after caudal block.

  13. Postoperative Respiratory Depression

    if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.

    Measured: 4 hours after caudal block.

  14. Postoperative Respiratory Depression

    if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.

    Measured: 6 hours after caudal block.

  15. Postoperative Respiratory Depression

    if the SpO2 is less than 95% or breathing rate is less than 10 breaths per minute.

    Measured: 12 hours after caudal block.

Timeline

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

  1. First posted7 Jan 2021
  2. Study startFeb 2021 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionSep 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Factorial Assignment Anesthesia will be induced with 100% oxygen and sevoflurane 8%. Once achieving the desired depth of anesthesia, I/V access will be taken. Propofol 3mg/kg and Nalbuphine 0.1mg/kg will be given. LMA of desirable size will be placed. After this, patient would be placed in lateral position for caudal Block. After all aseptic measures, Caudal Block procedure will be done with help of 23G needle by anatomical landmarks. On negative aspiration of the syringe, one of the drug combinations as explained under 'arms and intervention' will be used for the caudal block. First surgical incision will be given 10 mins after the application of caudal block. After the completion of surgery, LMA will be removed once the patient is awake and the patient will be shifted to PACU. IV paracetamol 15mg/kg will be given if FLACC score is more than 4 at any point during the surgery.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700228
Sponsor's protocol ID
Haris123
Status last verified
Jan 2021
First submitted
6 Jan 2021
Last updated
7 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine Hydrochloride and Dexmedetomidine in people with Pain, Postoperative, run by Dr. Ruth K.M. Pfau Civil Hospital, Karachi at 1 site in Pakistan.

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 7 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 7 Jan 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 Pakistan. 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 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?

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?

Duration of Analgesia (time frame: 1 hour after caudal block). The study lists 5 primary outcomes in all. 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 7 Jan 2021.

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Clinical Trial NCT04700228 | AzTrials