Clinical trial NCT02315261: Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery
Official title: Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery in Siriraj Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia Disorder
Anesthetic Complication Epidural
Adverse Reaction to Epidural Anesthesia
Keywords: Epidural analgesia
Pain score
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7
timeFrame: at postoperative 24 hours
Secondary outcomes:
measure: Number of Patients Requiring Rescue Analgesic Medication
timeFrame: during the period of retaining of epidural catheter up to 3 days after operation
measure: Duration Retaining Epidural Catheter
timeFrame: the period of retaining of epidural catheter up to 3 days after operation
measure: All Adverse Effects and Postoperative Complications.
timeFrame: the period of retaining of epidural catheter up to 3 days after operation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Mingkwan Wongyingsinn, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.