Adverse Reaction to Epidural Anesthesia, Analgesia Disorder, Anesthetic Complication Epidural
Conditions
Keywords
Epidural analgesia, Pain score
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREElective Thoracic and Abdominal Surgery Patients
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.
Sponsors
Siriraj Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged more than 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Exclusion criteria
* inability to communicate or inform pain score * cesarean section or labor analgesia * additional analgesic techniques (spinal analgesia, paravertebral nerve block, intercostal block, transversus abdominis plane block, rectus sheath block, ilioinguinal block, iliohypogastric block * emergency surgery * fail epidural block after test dose of local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7 | at postoperative 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Rescue Analgesic Medication | during the period of retaining of epidural catheter up to 3 days after operation | Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation |
| Duration Retaining Epidural Catheter | the period of retaining of epidural catheter up to 3 days after operation | Duration retaining epidural catheter in hospital |
| All Adverse Effects and Postoperative Complications. | the period of retaining of epidural catheter up to 3 days after operation | 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epidural Group Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital | 364 |
| Total | 364 |
Baseline characteristics
| Characteristic | Epidural Group |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 13 |
| ASA physical classification ASA physical status I | 53 Participants |
| ASA physical classification ASA physical status II | 215 Participants |
| ASA physical classification ASA physical status III | 94 Participants |
| ASA physical classification ASA physical status IV | 2 Participants |
| Body Mass Index | 23.9 kg/m^2 STANDARD_DEVIATION 5.1 |
| Duration of surgery | 192 minutes STANDARD_DEVIATION 85 |
| Sex: Female, Male Female | 122 Participants |
| Sex: Female, Male Male | 242 Participants |
| Surgical site Lower abdomen | 192 Participants |
| Surgical site Thoracic | 36 Participants |
| Surgical site Upper abdomen | 131 Participants |
| Surgical site Whole abdomen | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 364 |
| other Total, other adverse events | 213 / 364 |
| serious Total, serious adverse events | 42 / 364 |
Outcome results
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.
Time frame: at postoperative 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Group | Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7 | 89 Participants |
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.
Time frame: the period of retaining of epidural catheter up to 3 days after operation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epidural Group | All Adverse Effects and Postoperative Complications. | Postoperative nausea and vomiting | 100 participants |
| Epidural Group | All Adverse Effects and Postoperative Complications. | Hypotension | 28 participants |
| Epidural Group | All Adverse Effects and Postoperative Complications. | Accidental dural puncture | 5 participants |
| Epidural Group | All Adverse Effects and Postoperative Complications. | Post-dural puncture headache | 3 participants |
Secondary
Duration Retaining Epidural Catheter
Duration retaining epidural catheter in hospital
Time frame: the period of retaining of epidural catheter up to 3 days after operation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Epidural Group | Duration Retaining Epidural Catheter | 55.8 hours |
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
Time frame: during the period of retaining of epidural catheter up to 3 days after operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Group | Number of Patients Requiring Rescue Analgesic Medication | 50 Participants |