Analgesia, Patient-ControlledNCT03252977
Tailored PCA Based on Preoperative Pain Sensitivity
A study testing Tailored regimen of IV PCA according to pain sensitivity and Regimen of IV PCA without considering pain sensitivity in people with Analgesia, Patient-Controlled, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Patient-Controlled
- What is being tested?
- Tailored regimen of IV PCA according to pain sensitivity and Regimen of IV PCA without considering pain sensitivity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2017to 24 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients
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.
- Conditions
- Analgesia, Patient-Controlled
- Being tested
- Tailored regimen of IV PCA according to pain sensitivity, Regimen of IV PCA without considering pain sensitivity
- Keywords
- fentanyl, Pain Threshold, predicted
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored regimen of IV PCA according to pain sensitivityOther
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.
Regimen of IV PCA without considering pain sensitivityOther
In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Tailored group | Experimental | 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. Receives: Other: Tailored regimen of IV PCA according to pain sensitivity |
| control group | Sham comparator | 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. Receives: Other: Regimen of IV PCA without considering pain sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea
Incidence of postoperative nausea
Measured: during the postoperative 3 days
Secondary outcomes (9)
postoperative pain scores
numeric rating scale
Measured: during the postoperative 3 days
incidence of postoperative vomiting
incidence of postoperative vomiting
Measured: during the postoperative 3 days
Severity of postoperative nausea
numeric rating scale
Measured: during the postoperative 3 days
Incidence of other postoperative adverse effects
itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression
Measured: during the postoperative 3 days
cumulative dose of drug that infused via IV PCA
cumulative dose of drug that infused via IV PCA
Measured: during the postoperative 3 days
Incidence of IV PCA clamping
Incidence of IV PCA clamping
Measured: during the postoperative 3 days
rescue analgesics
amount of administered rescue analgesics
Measured: during the postoperative 3 days
antiemetic agents
amount of administered antiemetic agents
Measured: during the postoperative 3 days
satisfaction score
Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)
Measured: during the postoperative 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start21 Aug 2017
- Primary completion21 Nov 2017
- Study completion24 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Analgesia, Patient-ControlledStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252977
- Sponsor's protocol ID
- H-1707-078-869
- Status last verified
- Dec 2018
- First submitted
- 14 Aug 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24517836Hsu 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.
PubMed 16129988
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients
- ClinicalTrials.gov ID
- NCT03252977
- Acronym / sponsor ID
- H-1707-078-869
- Conditions
- Analgesia, Patient-Controlled
- Keywords
- fentanyl, Pain Threshold, predicted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored group | Experimental | Other: Tailored regimen of IV PCA according to pain sensitivityTailored 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. |
| control group | Sham comparator | Other: Regimen of IV PCA without considering pain sensitivityRegimen 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored regimen of IV PCA according to pain sensitivityIn 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. | Other | Tailored group |
| Regimen of IV PCA without considering pain sensitivityIn control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity. | Other | control group |
Primary outcome
postoperative nausea
Time frame: during the postoperative 3 days
Incidence of postoperative nausea
9 secondary outcomes
postoperative pain scores
Time frame: during the postoperative 3 days
incidence of postoperative vomiting
Time frame: during the postoperative 3 days
Severity of postoperative nausea
Time frame: during the postoperative 3 days
Incidence of other postoperative adverse effects
Time frame: during the postoperative 3 days
cumulative dose of drug that infused via IV PCA
Time frame: during the postoperative 3 days
Incidence of IV PCA clamping
Time frame: during the postoperative 3 days
rescue analgesics
Time frame: during the postoperative 3 days
antiemetic agents
Time frame: during the postoperative 3 days
satisfaction score
Time frame: during the postoperative 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 24517836Ahmad 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.
- Background: PubMed 16129988Hsu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored regimen of IV PCA according to pain sensitivity and Regimen of IV PCA without considering pain sensitivity in people with Analgesia, Patient-Controlled, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea (time frame: during the postoperative 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252977, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.