Major Orthopedic Hip SurgeryNCT01930201
Caudal Epidural Block for Postoperative Analgesia in Adolescents Following Major Hip Surgery.
An observational study of Major Orthopedic Hip Surgery, run by David P. Martin at 1 site in United States.
Trial summary
This retrospective chart review will demonstrate the feasibility of performing caudal epidural blockade in adolescents undergoing major orthopedic hip surgery and provide information regarding the feasibility of this technique's use on a regular basis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Orthopedic Hip Surgery
- What is being tested?
- Caudal epidural block and General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had major orthopedic hip surgery.
Who may be able to join
- Adolescents that underwent major orthopedic hip surgery.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This retrospective chart review will demonstrate the feasibility of performing caudal epidural blockade in adolescents undergoing major orthopedic hip surgery and provide information regarding the feasibility of this technique's use on a regular basis.
- Conditions
- Major Orthopedic Hip Surgery
- Being tested
- Caudal epidural block, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal epidural blockProcedure or surgery
General anesthesiaOther
| Study group | Role | What they receive |
|---|---|---|
| Standard general anesthesia | Patients receiving standard of care. Receives: Other: General anesthesia | |
| Caudal Epidural Block | Patients receiving a caudal epidural block in addition to standard of care. Receives: Procedure: Caudal epidural block; Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Assessing pain scores post-operatively.
Measured: During 1st 24 hours post-op
Secondary outcomes (2)
Pain medication requirement
Assessing amount of pain medication required.
Measured: During 1st 24 hours post-op
Antiemetic medication requirement
Assessing need for antiemetic medications post-operatively.
Measured: During 1st 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Orthopedic Hip SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- David P. Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David P. Martin, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930201
- Sponsor's protocol ID
- IRB12-00842
- Status last verified
- Oct 2014
- First submitted
- 9 Jul 2013
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Epidural Block for Postoperative Analgesia in Adolescents Following Major Hip Surgery.
- ClinicalTrials.gov ID
- NCT01930201
- Acronym / sponsor ID
- IRB12-00842
- Conditions
- Major Orthopedic Hip Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- David P. MartinUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Aug 2013 (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.
This retrospective chart review will demonstrate the feasibility of performing caudal epidural blockade in adolescents undergoing major orthopedic hip surgery and provide information regarding the feasibility of this technique's use on a regular basis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard general anesthesia | – | Other: General anesthesiaPatients receiving standard of care. |
| Caudal Epidural Block | – | Procedure: Caudal epidural block, Other: General anesthesiaPatients receiving a caudal epidural block in addition to standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had major orthopedic hip surgery.
Key inclusion criteria (1 listed)
- Adolescents that underwent major orthopedic hip surgery.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Caudal epidural block | Procedure or surgery | Caudal Epidural Block |
| General anesthesia | Other | Caudal Epidural Block, Standard general anesthesia |
Primary outcome
Pain
Time frame: During 1st 24 hours post-op
Assessing pain scores post-operatively.
2 secondary outcomes
Pain medication requirement
Time frame: During 1st 24 hours post-op
Antiemetic medication requirement
Time frame: During 1st 24 hours post-op
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 29 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Orthopedic Hip Surgery, run by David P. Martin at 1 site 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 1 inclusion and 1 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 29 Oct 2014. 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 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?
Pain (time frame: During 1st 24 hours post-op). 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 29 Oct 2014.