search
Back to results

Tailored PCA Based on Preoperative Pain Sensitivity

Primary Purpose

Analgesia, Patient-Controlled

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tailored regimen of IV PCA according to pain sensitivity
Regimen of IV PCA without considering pain sensitivity
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia, Patient-Controlled focused on measuring fentanyl, Pain Threshold, predicted

Eligibility Criteria

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

Inclusion Criteria:

  • patients scheduled to undergo elective gynecological surgery under general anesthesia
  • patients scheduled to use IV PCA for postoperative analgesia
  • patients with American Society of Anesthesiologists (ASA) physical status classification I, II, III

Exclusion Criteria:

  • contraindication to fentanyl use
  • inability to communication
  • age less than 18 years, or more than 80 years
  • body weight less than 40kg, or more than 90kg
  • morbid cardiovascular disease
  • pregnancy

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Tailored group

control group

Arm Description

Tailored regimen of IV PCA according to pain sensitivity The regimen of IV PCA will be determined according to preoperative pain sensitivity of patients. Pressure pain threshold will be measured preoperatively in these patients using pressure algometer. Patients with low pain threshold will use high dose IV PCA containing fentanyl 1500mcg, while patients with high pain threshold will use low dose IV PCA containing fentanyl 1000mcg.

Regimen of IV PCA without considering pain sensitivity The regimen of IV PCA will be determined according to experimental group patient assignments. Pressure pain threshold will not be measured in these patients. Patients will use IV PCA with fentanyl 1000mcg or fentanyl 1500mcg. The determination will be paired to assignment of experimental group.

Outcomes

Primary Outcome Measures

postoperative nausea
Incidence of postoperative nausea

Secondary Outcome Measures

postoperative pain scores
numeric rating scale
incidence of postoperative vomiting
incidence of postoperative vomiting
Severity of postoperative nausea
numeric rating scale
Incidence of other postoperative adverse effects
itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression
cumulative dose of drug that infused via IV PCA
cumulative dose of drug that infused via IV PCA
Incidence of IV PCA clamping
Incidence of IV PCA clamping
rescue analgesics
amount of administered rescue analgesics
antiemetic agents
amount of administered antiemetic agents
satisfaction score
Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)

Full Information

First Posted
August 14, 2017
Last Updated
December 16, 2018
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03252977
Brief Title
Tailored PCA Based on Preoperative Pain Sensitivity
Official Title
The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
November 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

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
Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for postoperative pain control. However, effective pain control with minimized side effects of analgesic agents is still challenging. Several studies reported that preoperative pain sensitivity measured by quantitative sensory test could predict postoperative pain. Therefore, the investigators planned this trial to evaluate the effectiveness of tailored patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain threshold in patients undergoing gynecological surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Patient-Controlled
Keywords
fentanyl, Pain Threshold, predicted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored group
Arm Type
Experimental
Arm Description
Tailored regimen of IV PCA according to pain sensitivity The regimen of IV PCA will be determined according to preoperative pain sensitivity of patients. Pressure pain threshold will be measured preoperatively in these patients using pressure algometer. Patients with low pain threshold will use high dose IV PCA containing fentanyl 1500mcg, while patients with high pain threshold will use low dose IV PCA containing fentanyl 1000mcg.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
Regimen of IV PCA without considering pain sensitivity The regimen of IV PCA will be determined according to experimental group patient assignments. Pressure pain threshold will not be measured in these patients. Patients will use IV PCA with fentanyl 1000mcg or fentanyl 1500mcg. The determination will be paired to assignment of experimental group.
Intervention Type
Other
Intervention Name(s)
Tailored regimen of IV PCA according to pain sensitivity
Intervention Description
In tailored group, fentanyl dosage in IV PCA will be determined according to preoperative pain sensitivity. In control, group, fentanyl dosage in IV PCA will be determined without consideration of patient's pain sensitivity.
Intervention Type
Other
Intervention Name(s)
Regimen of IV PCA without considering pain sensitivity
Intervention Description
In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.
Primary Outcome Measure Information:
Title
postoperative nausea
Description
Incidence of postoperative nausea
Time Frame
during the postoperative 3 days
Secondary Outcome Measure Information:
Title
postoperative pain scores
Description
numeric rating scale
Time Frame
during the postoperative 3 days
Title
incidence of postoperative vomiting
Description
incidence of postoperative vomiting
Time Frame
during the postoperative 3 days
Title
Severity of postoperative nausea
Description
numeric rating scale
Time Frame
during the postoperative 3 days
Title
Incidence of other postoperative adverse effects
Description
itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression
Time Frame
during the postoperative 3 days
Title
cumulative dose of drug that infused via IV PCA
Description
cumulative dose of drug that infused via IV PCA
Time Frame
during the postoperative 3 days
Title
Incidence of IV PCA clamping
Description
Incidence of IV PCA clamping
Time Frame
during the postoperative 3 days
Title
rescue analgesics
Description
amount of administered rescue analgesics
Time Frame
during the postoperative 3 days
Title
antiemetic agents
Description
amount of administered antiemetic agents
Time Frame
during the postoperative 3 days
Title
satisfaction score
Description
Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)
Time Frame
during the postoperative 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients scheduled to undergo elective gynecological surgery under general anesthesia patients scheduled to use IV PCA for postoperative analgesia patients with American Society of Anesthesiologists (ASA) physical status classification I, II, III Exclusion Criteria: contraindication to fentanyl use inability to communication age less than 18 years, or more than 80 years body weight less than 40kg, or more than 90kg morbid cardiovascular disease pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24517836
Citation
Ahmad S, De Oliveira GS Jr, Bialek JM, McCarthy RJ. Thermal quantitative sensory testing to predict postoperative pain outcomes following gynecologic surgery. Pain Med. 2014 May;15(5):857-64. doi: 10.1111/pme.12374. Epub 2014 Feb 12.
Results Reference
background
PubMed Identifier
16129988
Citation
Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.
Results Reference
background

Learn more about this trial

Tailored PCA Based on Preoperative Pain Sensitivity

We'll reach out to this number within 24 hrs