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This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.
Epidural analgesia is the recommended perioperative analgesia in patients having major surgery in order to significantly reduced pain scores, minimize patient distress and can accelerate postoperative recovery especially with the major operation This technique has been reported to provide better pain control and less postoperative fatigue compared with patients receiving general anesthesia alone.Additionally, it is recommended in patients having major surgery to allow patients to mobilize quickly and have effective mobilization.This technique has been shown to be highly efficient at preventing postoperative ileus and various complications. Moreover, epidural analgesic technique is demonstrated to be safer and have fewer side effects than using intravenous opioids alone.
However, the epidural technique is not universally successful and the number of patients experiencing inadequate analgesia with this technique is approximately 12-32%. The failure of epidural analgesia is still a frequent clinical problem and needs active management including a new block or other analgesic medication in order to rescue postoperative pain. Previous study showed that the incidence of patients having epidural analgesia with postoperative moderate pain was 20.9% and that with severe pain was 7.8%. In Siriraj Hospital, recent study showed that 19.6% of patients having elective upper abdominal surgery under general anesthesia combined with epidural analgesia reported severe first pain scores in post anesthetic care unit.27 As a result of severe pain, patients needed a number of intervention and management from acute pain service, and finally spent longer time in post anesthetic care unit.
Inadequate pain control in patients receiving epidural analgesia frequently occurred in clinical practice but the number of the success rate or the failure rate have not been reported in our hospital. This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elective Thoracic and Abdominal Surgery Patients | Procedure | This is an observational audit, reviewing the implementation of a standard care practice and requiring de-identified data collection in Elective Thoracic and Abdominal Surgery Patients only. All collected data will be that which is routinely part of normal clinical practice. The Research staff will systematically collect data on each patient. Some information can be obtained from the medical record, intraoperative anesthetic record, acute pain service record, etc whereas other information has to be obtained from direct observation at the bedside. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7 | Verbal Rating Scale Pain will routinely be assessed at postoperative 24 hours by the ward nurse. Minimum and maximum scores possible are 0 and 10. The higher values represent patients having more pain. Severe pain is defined as Verbal Rating Scale pain at rest more than 7. | at postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Rescue Analgesic Medication | Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation | during the period of retaining of epidural catheter up to 3 days after operation |
| Duration Retaining Epidural Catheter |
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Inclusion Criteria:
Exclusion Criteria:
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patients scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
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| Name | Affiliation | Role |
|---|---|---|
| Mingkwan Wongyingsinn, MD, MSc | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27501608 | Derived | Wongyingsinn M, Anuwongjaroen A. Effectiveness of Postoperative Epidural Analgesia for Thoracic and Abdominal Surgery in Siriraj Hospital. J Med Assoc Thai. 2016 May;99(5):531-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidural Group | Patients age > 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidural Group | Patients age > 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7 | Verbal Rating Scale Pain will routinely be assessed at postoperative 24 hours by the ward nurse. Minimum and maximum scores possible are 0 and 10. The higher values represent patients having more pain. Severe pain is defined as Verbal Rating Scale pain at rest more than 7. | Posted | Count of Participants | Participants | at postoperative 24 hours |
|
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidural Group | Patients age > 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative nausea and vomitting | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Mingkwan Wongyingsinn | Faculty of Medicine Siriraj Hospital | 66824197995 | 81 | minkcheerful@hotmail.com |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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Duration retaining epidural catheter in hospital |
| the period of retaining of epidural catheter up to 3 days after operation |
| All Adverse Effects and Postoperative Complications. | All Adverse Effects and Postoperative Complications included the number of patients having postoperative nausea and vomiting; hypotension; accidental dural puncture and post-dural puncture headache. | the period of retaining of epidural catheter up to 3 days after operation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| ASA physical classification | The ASA physical status classification system is a system for assessing the fitness of patients before surgery. In 1963 the American Society of Anesthesiologists (ASA) adopted this category physical status classification system as ASA physical status I: Healthy person. ASA physical status II: Mild systemic disease. ASA physical status III: Severe systemic disease. ASA physical status IV: Severe systemic disease that is a constant threat to life. | Count of Participants | Participants |
|
| Surgical site | Count of Participants | Participants |
|
| Duration of surgery | Mean | Standard Deviation | minutes |
|
| Participants |
|
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| Secondary | Number of Patients Requiring Rescue Analgesic Medication | Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation | Posted | Count of Participants | Participants | during the period of retaining of epidural catheter up to 3 days after operation |
|
|
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| Secondary | Duration Retaining Epidural Catheter | Duration retaining epidural catheter in hospital | Posted | Mean | 95% Confidence Interval | hours | the period of retaining of epidural catheter up to 3 days after operation |
|
|
|
| Secondary | All Adverse Effects and Postoperative Complications. | All Adverse Effects and Postoperative Complications included the number of patients having postoperative nausea and vomiting; hypotension; accidental dural puncture and post-dural puncture headache. | Posted | Number | participants | the period of retaining of epidural catheter up to 3 days after operation |
|
|
|
| 0 |
| 364 |
| 42 |
| 364 |
| 213 |
| 364 |
| Motor weakness | Nervous system disorders | Non-systematic Assessment |
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| Dural puncture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pruritus | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Urinary retention | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Title | Measurements |
|---|
|
| Post-dural puncture headache |
|