Trial Outcomes & Findings for Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery (NCT NCT02315261)

Last Updated: 2018-11-13

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

364 participants

Primary outcome timeframe

at postoperative 24 hours

Results posted on

2018-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Epidural Group Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Overall Study STARTED	364
Overall Study COMPLETED	364
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidural Group n=364 Participants Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Age, Continuous	59 years STANDARD_DEVIATION 13 • n=99 Participants
Sex: Female, Male Female	122 Participants n=99 Participants
Sex: Female, Male Male	242 Participants n=99 Participants
Body Mass Index	23.9 kg/m^2 STANDARD_DEVIATION 5.1 • n=99 Participants
ASA physical classification ASA physical status I	53 Participants n=99 Participants
ASA physical classification ASA physical status II	215 Participants n=99 Participants
ASA physical classification ASA physical status III	94 Participants n=99 Participants
ASA physical classification ASA physical status IV	2 Participants n=99 Participants
Surgical site Thoracic	36 Participants n=99 Participants
Surgical site Upper abdomen	131 Participants n=99 Participants
Surgical site Lower abdomen	192 Participants n=99 Participants
Surgical site Whole abdomen	5 Participants n=99 Participants
Duration of surgery	192 minutes STANDARD_DEVIATION 85 • n=99 Participants

PRIMARY outcome

Timeframe: at postoperative 24 hours

Outcome measures

Outcome measures
Measure	Epidural Group n=364 Participants Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7	89 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Epidural Group n=364 Participants Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Number of Patients Requiring Rescue Analgesic Medication	50 Participants

SECONDARY outcome

Timeframe: the period of retaining of epidural catheter up to 3 days after operation

Duration retaining epidural catheter in hospital

Outcome measures

Outcome measures
Measure	Epidural Group n=364 Participants Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Duration Retaining Epidural Catheter	55.8 hours Interval 53.9 to 57.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Epidural Group n=364 Participants Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
All Adverse Effects and Postoperative Complications. Postoperative nausea and vomiting	100 participants
All Adverse Effects and Postoperative Complications. Hypotension	28 participants
All Adverse Effects and Postoperative Complications. Accidental dural puncture	5 participants
All Adverse Effects and Postoperative Complications. Post-dural puncture headache	3 participants

Adverse Events

Epidural Group

Serious events: 42 serious events

Other events: 213 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Epidural Group n=364 participants at risk Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Cardiac disorders Hypotension	7.7% 28/364 • 3 days
Nervous system disorders Motor weakness	2.5% 9/364 • 3 days
Injury, poisoning and procedural complications Dural puncture	1.4% 5/364 • 3 days

Other adverse events

Other adverse events
Measure	Epidural Group n=364 participants at risk Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital
Injury, poisoning and procedural complications Postoperative nausea and vomitting	27.5% 100/364 • 3 days
Injury, poisoning and procedural complications Pruritus	29.9% 109/364 • 3 days
Injury, poisoning and procedural complications Urinary retention	1.1% 4/364 • 3 days

Additional Information

Dr.Mingkwan Wongyingsinn

Faculty of Medicine Siriraj Hospital

Phone: 66824197995

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place