Inguinal HerniaNCT01494272
Analgesia in Children Using Caudal Epidural Ropivacaine
An observational study of Inguinal Hernia and Circumcision, run by Loma Linda University at 2 sites in United States.
Trial summary
Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Read more about this study
- Who is it for?
- Ages 2 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Circumcision
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to May 2015
- Phase
- Observational
- 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 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children under 2 years of age having an elective inguinal herniorrhaphy or orchiopexy.
Who may be able to join
- Age 2 months to 2 years
- Weight 25kg or less
- ASA class 1, 2, 3
- Elective inguinal herniorrhaphy or orchiopexy
Who cannot join
- Contraindications to caudal epidural analgesia
- parent's refusal
- skeletal or spinal cord anomaly
- coagulopathy
- infection at the insertion site
- ongoing bacteremia
- allergy to ropivacaine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University Medical Center
Loma Linda, California, 92354
Loma Linda University Outpatient Surgery Center
Loma Linda, California, 92354
About this study
Official title: Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study
Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).
This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements
- Conditions
- Inguinal Hernia, Circumcision
- Keywords
- caudal epidural analgesia, elective circumcision, elective inguinal herniorrhaphy
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group CB (Caudal Before-study group) | This group will receive caudal ropivacaine and epinephrine after induction of general anesthesia prior to surgical incision | |
| Caudal After (CA)-control group | This group will receive caudal ropivacaine with epinephrine after completion of surgery but before emergence from anesthesia | |
| Local Infiltration After (LIA) control group | This group will receive local infiltration of ropivacaine around the surgery site at the conclusion of surgery but before emergence from anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of pain medications
Measured: over 24 hours
Secondary outcomes (1)
Pain scores
Measured: At various intervals for first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Mulder, MD, Loma Linda University
- Investigators
- Shannon Mulder, MD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494272
- Sponsor's protocol ID
- 5110235
- Status last verified
- Nov 2015
- First submitted
- 15 Dec 2011
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study
- ClinicalTrials.gov ID
- NCT01494272
- Acronym / sponsor ID
- 5110235
- Conditions
- Inguinal Hernia, Circumcision
- Keywords
- caudal epidural analgesia, elective circumcision, elective inguinal herniorrhaphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Dec 2011 (estimated)
- 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.
Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).
This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group CB (Caudal Before-study group) | – | –This group will receive caudal ropivacaine and epinephrine after induction of general anesthesia prior to surgical incision |
| Caudal After (CA)-control group | – | –This group will receive caudal ropivacaine with epinephrine after completion of surgery but before emergence from anesthesia |
| Local Infiltration After (LIA) control group | – | –This group will receive local infiltration of ropivacaine around the surgery site at the conclusion of surgery but before emergence from anesthesia |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children under 2 years of age having an elective inguinal herniorrhaphy or orchiopexy.
Key inclusion criteria (4 listed)
- Age 2 months to 2 years
- Weight 25kg or less
- ASA class 1, 2, 3
- Elective inguinal herniorrhaphy or orchiopexy
Key exclusion criteria (7 listed)
- Contraindications to caudal epidural analgesia
- parent's refusal
- skeletal or spinal cord anomaly
- coagulopathy
- infection at the insertion site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usage of pain medications
Time frame: over 24 hours
1 secondary outcome
Pain scores
Time frame: At various intervals for first 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 25 Nov 2015.
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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.
Shannon Mulder, MD principal investigator
Loma Linda University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Circumcision, run by Loma Linda University at 2 sites in United States.
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 4 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: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
Usage of pain medications (time frame: over 24 hours). 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 25 Nov 2015.