Epidural AnalgesiaNCT06301932
The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy
An observational study of Epidural Analgesia and Patient Controlled Analgesia, run by Chiang Mai University.
Trial summary
This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis. The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidural Analgesia, Patient Controlled Analgesia
- What is being tested?
- Open liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 654 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients more than 18 years old, who underwent an open hepatectomy between January 2007 - December 2018 at Maharay Nakhon Chiangmai Hospital
Who may be able to join
- All gender age above 18 years old
- Undergoing open liver resection surgery
Who cannot join
- No documentation of the numerical rating scale (NRS)
- Epidural failure
About this study
Official title: The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy: A Propensity Score Matching Analysis
This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.
The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA?
Read the detailed description
After approval of the study protocol from the institutional review board of Chiangmai University (Approval number: ANE-2562-06771), the investigators performed a retrospective review of all patients who underwent an elective open liver resection in the specialized hepato-biliary center from January 2007 through December 2018. This retrospective inquiry comprised 612 patients. The data was systematically retrieved from electronic medical records. Baseline characteristics including age, gender, body mass index (BMI), co-morbidity, American Society of Anesthesiologists (ASA) classification, diagnosis, hepatitis profile, Child-Pugh classification, cirrhosis, the largest tumor size, previous liver resection, and pre-operative laboratory investigations were collected. The following intra-operative data were collected: type of liver resection, hilar resection, vascular reconstruction, intra-operative opioid consumption and type of fluid administration, estimated blood loss, packed red cell and blood product transfusion, and operation time. Post-operative pain score and opioid consumption also be collected.
- Conditions
- Epidural Analgesia, Patient Controlled Analgesia
- Being tested
- Open liver resection
- Keywords
- Liver resection, Propensity score matching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open liver resectionProcedure or surgery
The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Group of the patients received epidural analgesia Receives: Procedure: Open liver resection | |
| Non epidural analgesia | Group of the patients who did not received epidural analgesia Receives: Procedure: Open liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative opioid consumption
Post-operative opioid consumption at 24,48,72 hour
Measured: Within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jan 2006
- Primary completion31 Dec 2018
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural AnalgesiaStudies 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
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isarapong Pianngarn, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301932
- Sponsor's protocol ID
- ANE-2562-06771
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pianngarn I, Lapisatepun W, Kulpanun M, Chotirosniramit A, Junrungsee S, Lapisatepun W. The effectiveness and outcomes of epidural analgesia in patients undergoing open liver resection: a propensity score matching analysis. BMC Anesthesiol. 2024 Sep 2;24(1):305. doi: 10.1186/s12871-024-02697-1.
PubMed 39223470
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Outcomes of Epidural Analgesia in Patients Undergoing Open Hepatectomy: A Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT06301932
- Acronym / sponsor ID
- ANE-2562-06771
- Conditions
- Epidural Analgesia, Patient Controlled Analgesia
- Keywords
- Liver resection, Propensity score matching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Mar 2024 (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.
This observational study is to compare the effectiveness and outcomes of epidural analgesia in patients undergoing open hepatectomy: A propensity score matching analysis.
The main question is: What is the superior method of pain control in open hepatectomy: epidural analgesia or intravenous PCA?
Detailed description
After approval of the study protocol from the institutional review board of Chiangmai University (Approval number: ANE-2562-06771), the investigators performed a retrospective review of all patients who underwent an elective open liver resection in the specialized hepato-biliary center from January 2007 through December 2018. This retrospective inquiry comprised 612 patients. The data was systematically retrieved from electronic medical records. Baseline characteristics including age, gender, body mass index (BMI), co-morbidity, American Society of Anesthesiologists (ASA) classification, diagnosis, hepatitis profile, Child-Pugh classification, cirrhosis, the largest tumor size, previous liver resection, and pre-operative laboratory investigations were collected. The following intra-operative data were collected: type of liver resection, hilar resection, vascular reconstruction, intra-operative opioid consumption and type of fluid administration, estimated blood loss, packed red cell and blood product transfusion, and operation time. Post-operative pain score and opioid consumption also be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | – | Procedure: Open liver resectionGroup of the patients received epidural analgesia |
| Non epidural analgesia | – | Procedure: Open liver resectionGroup of the patients who did not received epidural analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients more than 18 years old, who underwent an open hepatectomy between January 2007 - December 2018 at Maharay Nakhon Chiangmai Hospital
Key inclusion criteria (2 listed)
- All gender age above 18 years old
- Undergoing open liver resection surgery
Key exclusion criteria (2 listed)
- No documentation of the numerical rating scale (NRS)
- Epidural failure
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 |
|---|---|---|
| Open liver resectionThe definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology | Procedure or surgery | Epidural analgesia, Non epidural analgesia |
Primary outcome
Post-operative opioid consumption
Time frame: Within 72 hours
Post-operative opioid consumption at 24,48,72 hour
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 12 Mar 2024.
- Derived from this study: PubMed 39223470Pianngarn I, Lapisatepun W, Kulpanun M, Chotirosniramit A, Junrungsee S, Lapisatepun W. The effectiveness and outcomes of epidural analgesia in patients undergoing open liver resection: a propensity score matching analysis. BMC Anesthesiol. 2024 Sep 2;24(1):305. doi: 10.1186/s12871-024-02697-1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural Analgesia and Patient Controlled Analgesia, run by Chiang Mai University.
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 2 inclusion and 2 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Post-operative opioid consumption (time frame: Within 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06301932, which also lists 1 linked publication.
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 12 Mar 2024.