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.
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
- Conditions the study is for
- Ropivacaine, Infraumbilical Surgery, Dexmedetomidine
- 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
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
- To compare rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)in 24 hours of postoperative period.
- To compare the time for first rescue analgesia.
- To evaluate the total analgesics consumption in 24 hours of postoperative period.
- To observe the side effects of study drugs (vomiting and bradycardia).
- Conditions
- Ropivacaine, Infraumbilical Surgery, Dexmedetomidine, Analgesia
- 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 group | Role | What they receive |
|---|---|---|
| Ropivacaine with dexmedetomidine | Experimental | Not described Receives: Drug: ropivacaine with dexmedetomidine |
| Ropivacaine with Normal Saline | Placebo comparator | Not described Receives: Drug: Ropivacaine with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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.
- First posted7 Aug 2023
- Study start16 Jun 2020
- Primary completion10 Jun 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RopivacaineStudies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- National Academy of Medical Sciences, Nepal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kaushal Tamang, National Academy of Medical Sciences, Nepal
- Investigators
- Kaushal Tamang, MBBS,MD, Principal investigator, NAMSBidur K Baral, MBBS,MD, Study chair, NAMSSadichhya S Malla, MBBS,MD, Study chair, Kanti Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Caudal Ropivacaine With or Without Dexmedetomidine for Postoperative Analgesia in Pediatric Infra-umbilical Surgery: A Double-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05979558
- Acronym / sponsor ID
- NamsNepal
- Conditions
- Ropivacaine, Infraumbilical Surgery, Dexmedetomidine, Analgesia
- Keywords
- ropivacaine, caudal ropivacaine, dexmedetomidine, placebo, analgesia, infraumbilical surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Academy of Medical Sciences, NepalOther government
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 7 Aug 2023 (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 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.
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
- To compare rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)in 24 hours of postoperative period.
- To compare the time for first rescue analgesia.
- To evaluate the total analgesics consumption in 24 hours of postoperative period.
- To observe the side effects of study drugs (vomiting and bradycardia).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine with dexmedetomidine | Experimental | Drug: ropivacaine with dexmedetomidine |
| Ropivacaine with Normal Saline | Placebo comparator | Drug: Ropivacaine with placebo |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of either sex aged 2-7 years
- ASA (American Society of Anesthesiologist) physical status I or II
- Patients undergoing elective infraumbilical surgeries
Key exclusion criteria (6 listed)
- History of neuromuscular or psychiatric disease
- Coagulation disorders
- Skin lesion at the site of injection
- Spine deformity
- History of developmental delay
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 |
|---|---|---|
| ropivacaine with dexmedetomidinethis group received with ropivacaine with dexmedetomidine | Drug | Ropivacaine with dexmedetomidine |
| Ropivacaine with placebothis group received with ropivacaine with normal saline | Drug | Ropivacaine with Normal Saline |
Primary outcome
Duration of analgesia:
Time frame: upto first 24 hour after intervention
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.
Post-operative pain Assessment (rFLACC score) rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)
Time frame: first 24 hour after intervention
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.
Total analgesics consumption in first 24 hours postoperative period
Time frame: first 24 hours after intervention
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.
1 secondary outcome
Side effects of study drugs
Time frame: monitored for 24 hours and treated accordingly
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 7 Aug 2023.
Related trials for Ropivacaine
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
RecruitingPhase 3
Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery
Intravenous Lidocaine, Laparoscopic Surgery
Enrolling by invitation
Tramadol / Magnesium in Ropivacaine Solution in UG-bilateral TAP Block and Analgesia in Robotic Radical Prostatectomy
Perioperative Pain in Robotic Prostatectomy
Recruiting
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah
Pain, 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.
Kaushal Tamang, MBBS,MD principal investigator
NAMS
Bidur K Baral, MBBS,MD study chair
NAMS
Sadichhya S Malla, MBBS,MD study chair
Kanti Hospital
1 site in 1 country: see every site and its status.
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.