Epidural AnalgesiaNCT04111406
Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice
A study testing Current practice and Protocol based in people with Epidural Analgesia and Postoperative Pain, run by Mahidol University at 1 site in Thailand.
Trial summary
Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidural Analgesia, Postoperative Pain
- What is being tested?
- Current practice and Protocol based
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteThailand
- Study dates
- 9 Jan 2019to 28 Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients age ≥ 18 years old undergo surgery with epidural catheter insertion at Siriraj hospital.
Who cannot join
- Coagulopathy
- Allergy to study drugs: local anesthetics and opioids
- History of chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.
Read the detailed description
A high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. The protocol based practice has been developed from acute pain service which founded for more than 10 years. By using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.
- Conditions
- Epidural Analgesia, Postoperative Pain
- Being tested
- Current practice, Protocol based
- Keywords
- Epidural Analgesia, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current practiceDrug
Epidural insertion and epidural drug administration depend on anesthetist in charge
Protocol basedDrug
Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based
- insertion at mid-level of surgical insertion
- insertion depth is 3-5 cm in space, not more than 5 cm
- using benzoin tincture and transparent dressing to fix catheter
- test dose with 2%xylocaine with adrenaline 1:200,000 3ml If not cover desired dermatome: 2% lidocaine with adr added 3 ml every 5 min (up to 2 times)
- After induction and patients' hemodynamic are stable. Load 2 mg morphine with 0.0625% bupivacaine + morphine 0.02 mg/ml 3 ml then continuous infusion with rate according to initial local anesthetic requirement for incisional area coverage
| Study group | Role | What they receive |
|---|---|---|
| Current practice | Other | Epidural insertion and epidural drug administration depend on anesthetist in charge Receives: Drug: Current practice |
| Protocol based | Experimental | Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based Receives: Drug: Protocol based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of inadequate epidural analgesia
To compare the overall incidence of inadequate epidural analgesia until considered removal between protocol-based and current practice by using the definition of inadequate analgesia as pain score of 4 or more out of 10 on numeric rating scale (0; no pain, 10; worst imaginable pain) at rest.
Measured: 72 hours
Secondary outcomes (1)
Side effects
To compare the incidence of undesirable side effects of epidural catheter between groups: sedation, respiratory depression, hypotension, motor weakness, postoperative nausea and vomiting and pruritus
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start9 Jan 2019
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Why it stopped: covid19 situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pawinee Pangthipampai, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111406
- Sponsor's protocol ID
- Si 342/2018
- Status last verified
- Jul 2022
- First submitted
- 29 Sep 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice
- ClinicalTrials.gov ID
- NCT04111406
- Acronym / sponsor ID
- Si 342/2018
- Conditions
- Epidural Analgesia, Postoperative Pain
- Keywords
- Epidural Analgesia, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: covid19 situation
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 1 Oct 2019 (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.
Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.
Detailed description
A high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. The protocol based practice has been developed from acute pain service which founded for more than 10 years. By using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019
| Arm | Type | Receives |
|---|---|---|
| Current practice | Other | Drug: Current practiceEpidural insertion and epidural drug administration depend on anesthetist in charge |
| Protocol based | Experimental | Drug: Protocol basedEpidural insertion and epidural drug administration depend on anesthetist in research team using protocol based |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients age ≥ 18 years old undergo surgery with epidural catheter insertion at Siriraj hospital.
Key exclusion criteria (3 listed)
- Coagulopathy
- Allergy to study drugs: local anesthetics and opioids
- History of chronic pain
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 |
|---|---|---|
| Current practiceEpidural insertion and epidural drug administration depend on anesthetist in charge | Drug | Current practice |
| Protocol basedEpidural insertion and epidural drug administration depend on anesthetist in research team using protocol based 1. insertion at mid-level of surgical insertion 2. insertion depth is 3-5 cm in space, not more than 5 cm 3. using benzoin tincture and transparent dressing to fix catheter 4. test dose with 2%xylocaine with adrenaline 1:200,000 3ml If not cover desired dermatome: 2% lidocaine with adr added 3 ml every 5 min (up to 2 times) 5. After induction and patients' hemodynamic are stable. Load 2 mg morphine with 0.0625% bupivacaine + morphine 0.02 mg/ml 3 ml then continuous infusion with rate according to initial local anesthetic requirement for incisional area coverage | Drug | Protocol based |
Primary outcome
Overall incidence of inadequate epidural analgesia
Time frame: 72 hours
To compare the overall incidence of inadequate epidural analgesia until considered removal between protocol-based and current practice by using the definition of inadequate analgesia as pain score of 4 or more out of 10 on numeric rating scale (0; no pain, 10; worst imaginable pain) at rest.
1 secondary outcome
Side effects
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: covid19 situation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Pawinee Pangthipampai, M.D. principal investigator
Siriraj 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 Current practice and Protocol based in people with Epidural Analgesia and Postoperative Pain, run by Mahidol University at 1 site in Thailand.
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 3 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: stopped early, as of the sponsor's last update on 26 Jul 2022. 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 Thailand. 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 was stopped early (reason given: covid19 situation). 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?
Overall incidence of inadequate epidural analgesia (time frame: 72 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 26 Jul 2022.