AzTrials
AzTrials

RopivacaineNCT05979558

Caudal Ropivacaine With or Without Dexmedetomidine for Post Operative Analgesia

A study testing ropivacaine with dexmedetomidine in people with Ropivacaine and Infraumbilical Surgery, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the postoperative analgesic effects of caudal Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main question[s] it aims to answer are: if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in children… Read more about this study

Who is it for?
Ages 2 to 7 years
What is being tested?
ropivacaine with dexmedetomidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteNepal
Study dates
16 Jun 2020to 10 Dec 2021
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 2 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children of either sex aged 2-7 years
  • ASA (American Society of Anesthesiologist) physical status I or II
  • Patients undergoing elective infraumbilical surgeries

Who cannot join

  • History of neuromuscular or psychiatric disease
  • Coagulation disorders
  • Skin lesion at the site of injection
  • Spine deformity
  • History of developmental delay
  • Allergy to study drugs

Trial locations and contacts

1 site in 1 country.

Nepal1 site
  • National Academy of Medical Sciences (NAMS)

    Kathmandu, Bagmati, 44600

Other trials in Nepal

About this study

Official title: Study of Caudal Ropivacaine With or Without Dexmedetomidine for Postoperative Analgesia in Pediatric Infra-umbilical Surgery: A Double-blinded Randomized Control Trial

The goal of this clinical trial is to evaluate the postoperative analgesic effects of caudal Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main question[s] it aims to answer are:

  • if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in children undergoing infraumbilical surgery.

Participants will receive ropivacaine with dexmedetomidine in infraumbilical surgery.

If there is a comparison group: Investigators will compare this with ropivacaine with a placebo to see if the duration of analgesia differs.

Read the detailed description

Children have significant pain following surgery. It has been under-managed most of the time. Poorly controlled post-operative pain increases the morbidity. It leads to post-operative agitation, urinary retention, nausea and vomiting, hypoxia, pulmonary edema, cardiovascular and temperature instability. So, postoperative pain management is an essential and important component of pediatric postoperative care. Adequate pain control after surgery permits early mobilization, reduces postoperative complication, prevents development of fear and anxiety and allows early hospital discharge.

Caudal block is one of the modality of multimodal analgesia. It is a well-established, effective and relatively safe technique used for intra and post-operative analgesia in children undergoing abdominal and lower limb surgery. It provides excellent analgesia, reduces intra-operative anesthetics drug requirements, ensures pain free recovery from anesthesia, decreases stress response and avoids deleterious adverse effects of narcotic drugs.

However, the main disadvantage of caudal block is being its short duration of action with sole local anesthetics. Even long-acting local anesthetic drugs such as bupivacaine provides only 4-8 hours of analgesia. The insertion of catheter in caudal space to administer repeated doses or continuous infusions of local anesthetic drug is not popular because of concerns of infection. So, various adjuvants like Fentanyl, Morphine, Ketamine, clonidine, Dexmeditomidine etc. have been used to prolong the duration of analgesia.

Morphine and Fentanyl are opioids that have been used traditionally in combination with a local anesthetic to achieve prolonged anesthetic effect. The addition of opioid does provide better analgesia but there is a possibility of an increased incidence of pruritus, urinary retention, nausea, vomiting and respiratory depression. Similarly, Ketamine and Clonidine are the widely preferred adjuvant to caudal block but have their own number of unpleasant adverse effects8.

Hence, there is still ongoing investigations to find for an adjuvant that can safely prolong caudal analgesia. Recently, Dexmedetomidine has been used for this purpose. Various studies have described the use of Dexmedetomidine with local anesthetic drugs in caudal block for the management of postoperative pain in children. Saadawy et al. found that 1μg/kg caudal dexmedetomidine with bupivacaine was associated with an extended duration of postoperative analgesia while in other studies 2μg/kg Dexmedetomidine was used with caudal Bupivacaine or Ropivacaine for providing postoperative analgesia in children undergoing lower abdominal and perineal surgeries.

Dexmedetomidine is a highly specific and selective α2-adrenoceptor agonist that has been described as a safe and effective additive in many anesthetic procedures. In contrast to other agents, it has a sympatholytic, analgesic and sedative effects. It is remarkably free from side effects except for hypotension and bradycardia. But studies investigating its analgesic property in our population are limited.

Ropivacaine is a long-acting amino amide local anesthetic drug and was the first to be formulated as a pure S-enantiomer. It is reported to have a better safety profile than Bupivacaine with less risk for central nervous system and cardiac toxicity 10. It also decreases unwanted motor block than Bupivacaine, which makes it a more suitable agent for caudal epidural analgesia6.

Dexmedetomidine with Ropivacaine is commonly used to prolong the caudal analgesia in western population but have not been well studied in our pediatric population. So investigators designed this study to determine analgesic effect of caudal Dexmedetomidine with Ropivacaine in pediatric infraumbilical surgeries.

HYPOTHESIS Caudal Dexmedetomidine with Ropivacaine would not prolong the duration of analgesia in children undergoing infraumbilical surgery.

GENERAL OBJECTIVES To evaluate the postoperative analgesic effects of caudal Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery SPECIFIC OBJECTIVES

  1. To compare rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)in 24 hours of postoperative period.
  2. To compare the time for first rescue analgesia.
  3. To evaluate the total analgesics consumption in 24 hours of postoperative period.
  4. To observe the side effects of study drugs (vomiting and bradycardia).
Being tested
ropivacaine with dexmedetomidine, Ropivacaine with placebo
Keywords
ropivacaine, caudal ropivacaine, dexmedetomidine, placebo, analgesia, infraumbilical surgery
Medical subject headings
Agnosia

What participants receive

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

  • ropivacaine with dexmedetomidineDrug

    this group received with ropivacaine with dexmedetomidine

  • Ropivacaine with placeboDrug

    this group received with ropivacaine with normal saline

Study groups in NCT05979558
Study groupRoleWhat they receive
Ropivacaine with dexmedetomidineExperimentalNot described
Receives: Drug: ropivacaine with dexmedetomidine
Ropivacaine with Normal SalinePlacebo comparatorNot described
Receives: Drug: Ropivacaine with placebo

What is being measured

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

  1. Duration of analgesia:

    The primary outcome will be the duration of analgesia defined as the time period between administration of study drugs to first need of rescue analgesia when until the time of rFLACC score (revised Face, Legs, Activity, Cry, and Consolability) reached ≥4.

    Measured: upto first 24 hour after intervention

  2. Post-operative pain Assessment (rFLACC score) rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)

    Each of the five categories F (face), L (legs), A (Activity), C (Cry), C (Consolability) will be scored from 0 to 2 which results total score in between zero and ten.

    Measured: first 24 hour after intervention

  3. Total analgesics consumption in first 24 hours postoperative period

    If r-FLACC pain score ≥4 at any time, an injection Paracetamol 15mg/kg will be given. If the r-FLACC pain score still ≥4 after 30 minutes of injection Paracetamol, then the child will treated with an injection Pethidine 0.5mg/kg. After that, an injection Paracetamol at 15mg/kg will be given 6 hourly. Total analgesic consumption in the first 24 hours will be calculated by adding the total analgesic consumed in 24 hours after the intervention.

    Measured: first 24 hours after intervention

Secondary outcomes (1)
  1. Side effects of study drugs

    Adverse events such as nausea, vomiting, bradycardia, respiratory depression and urinary retention will be monitored for 24 hours and treated accordingly

    Measured: monitored for 24 hours and treated accordingly

Timeline

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

  1. First posted7 Aug 2023
  2. Study start16 Jun 2020
  3. Primary completion10 Jun 2021
  4. Study completion10 Dec 2021

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979558
Sponsor's protocol ID
NamsNepal
Status last verified
Jul 2023
First submitted
21 Jul 2023
Last updated
7 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ropivacaine with dexmedetomidine in people with Ropivacaine and Infraumbilical Surgery, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.

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 6 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 7 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 Nepal. 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?

Duration of analgesia: (time frame: upto first 24 hour after intervention). The study lists 3 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 Aug 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in