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The Prediction for Postoperative Pain

Primary Purpose

Pain, Postoperative, Nociceptive Pain, Analgesia, Patient-Controlled

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
surgical pleth index
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

undergoing liver resection (laparoscopic or laparotomy)

Exclusion Criteria:

patients who refused to participate patients who have cardiac arrythmia patients who have allergic history for remifentanil

Sites / Locations

  • Samsung medical center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SPI Group

Arm Description

All patients who received the liver resection surgery will receive surgical pleth index

Outcomes

Primary Outcome Measures

The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score
The consumption of patient controlled analgesia and intraoperative surgical pleth index score

Secondary Outcome Measures

The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score
The consumption of patient controlled analgesia and intraoperative surgical pleth index score
The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score
The consumption of patient controlled analgesia and intraoperative surgical pleth index score
The correlation of postoperative pain score and intraoperative nociception score
The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score
The side effects of analgesics
nausea/vomiting, sedation, itching, respiratory depression

Full Information

First Posted
June 29, 2018
Last Updated
October 24, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03585088
Brief Title
The Prediction for Postoperative Pain
Official Title
Can we Predict Postoperative Analgesic Requirement by Intraoperative Nociception?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
October 19, 2018 (Actual)
Study Completion Date
October 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
If the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.
Detailed Description
Post-operative pain not only alleviates patient discomfort, but also delays recovery and thus prolongs the hospital stay. There are many ways to control postoperative pain, but analgesic infusion through venous route, patient controlled analgesia (PCA), especially narcotic analgesics, is often used to control the infusion when needed. However, because PCA is based on only age, weight, and underlying diseases, there are limitations in effective analgesia, and excessive sedation due to excessive infusion. Therefore, if the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. The noxious stimuli during surgery may have a negative effect on the healing process and surgical outcome of the wound due to stress reaction and catabolism, secretion of pituitary hormone, activation of the sympathetic nervous system, and immunological changes. Therefore, proper analgesia is needed during general anesthesia. A non-invasive, non-invasive analgesic device is currently available for Surgical pleth index (SPI) to assess the status of intraoperative analgesia. SPI = 100- (0.3 * heart beat interval + 0.7 * photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from the waveform of peripheral oxygen saturation. In the postoperative pain prediction study with SPI, the SPI value at the end of the operation was found to be proportional to the pain in the recovery room. However, only the pain score immediately after the operation was confirmed in these studies. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Nociceptive Pain, Analgesia, Patient-Controlled, Analgesics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPI Group
Arm Type
Other
Arm Description
All patients who received the liver resection surgery will receive surgical pleth index
Intervention Type
Device
Intervention Name(s)
surgical pleth index
Intervention Description
All patients applied surgical pleth index after recovery of spontaneous breathing at the time of peritoneum and skin closure under Bispectral index score <=60.
Primary Outcome Measure Information:
Title
The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score
Description
The consumption of patient controlled analgesia and intraoperative surgical pleth index score
Time Frame
intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 24 hour in postoperative phase
Secondary Outcome Measure Information:
Title
The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score
Description
The consumption of patient controlled analgesia and intraoperative surgical pleth index score
Time Frame
intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 6 hour in postoperative phase
Title
The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score
Description
The consumption of patient controlled analgesia and intraoperative surgical pleth index score
Time Frame
intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 48 hour in postoperative phase
Title
The correlation of postoperative pain score and intraoperative nociception score
Description
The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score
Time Frame
awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours
Title
The side effects of analgesics
Description
nausea/vomiting, sedation, itching, respiratory depression
Time Frame
awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: undergoing liver resection (laparoscopic or laparotomy) Exclusion Criteria: patients who refused to participate patients who have cardiac arrythmia patients who have allergic history for remifentanil
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16169893
Citation
Dolin SJ, Cashman JN. Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data. Br J Anaesth. 2005 Nov;95(5):584-91. doi: 10.1093/bja/aei227. Epub 2005 Sep 16.
Results Reference
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PubMed Identifier
29028932
Citation
Ledowski T, Sommerfield D, Slevin L, Conrad J, von Ungern-Sternberg BS. Surgical pleth index: prediction of postoperative pain in children? Br J Anaesth. 2017 Nov 1;119(5):979-983. doi: 10.1093/bja/aex300.
Results Reference
background
PubMed Identifier
27543532
Citation
Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.
Results Reference
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The Prediction for Postoperative Pain

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