Pain, PostoperativeNCT02982109
Pain Evaluation of Venous Cannulation to Predict Postoperative Pain
An observational study of Pain, Postoperative, run by Lund University at 1 site in Sweden.
Trial summary
The investigators have recently reported a relationship between pain induced by peripheral venous cannulation and postoperative pain. The purpose of this study is to validate this method of postoperative pain prediction in a larger cohort subjected to different types of surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 27 Feb 2017to 22 May 2017
- Phase
- Observational
- 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
Study population: Patients scheduled for elective surgery at Hallands Hospital Halmstad
Who may be able to join
- 18-80 years old
- Scheduled for surgery in Halmstad
- Prepared for surgery in the preoperative ward or ward 71 (day-case or direct admittance)
Who cannot join
- Inability to handle the Visual Analog Scale
- Hospitalized already before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Postoperative Pain From Individually Assessed Pain Intensity Levels Associated With Venous Cannulation
The investigators have recently reported a relationship between pain induced by peripheral venous cannulation and postoperative pain. The purpose of this study is to validate this method of postoperative pain prediction in a larger cohort subjected to different types of surgery.
Read the detailed description
- The investigators will study all adult (>18 years old) patients going through surgery at the site during a defined period of time. Before induction of anesthesia participants will be asked to assess (in VAS units) the pain intensity associated with peripheral venous cannulation. The maximum level of postoperative pain intensity will be recorded in the post-anesthesia care unit.
- After the endpoint of the study, the patient records will be reviewed, and de-identified relevant data be recorded and analyzed in the Statistical Package for the Social Sciences (SPSS) software.
- Sample size assessment: In a previous study patients scoring ≥ 2.0 on venous cannulation assessed their median pain postoperatively at 5.8 VAS units compared with 2.9 in those scoring < 2.0 - corresponding to a difference in maximum postoperative pain intensity of almost three VAS units. To statistically confirm, with unpaired non-parametric tests, 80 % power (β), and 95% probability (1- α), half of that difference (1.5 VAS units) in pain intensity level between patients scoring above or below 2.0 VAS units, respectively, would require 55 patients in each group subjected to the same kind of surgery. With 4 groups of cases and controls 440 patients would need to be included. As the study is strictly observational, 600 patients will be included to make up for possible missing data.
- Statistics: The Mann-Whitney U- test will be used to compare differences in postoperative pain intensity levels, and the Pearson Chi-square test to compare proportions of patients with moderate or severe postoperative pain, in patients differing in pain scores (above or below 2.0 VAS units) on venous cannulation. Logistic regression analysis will be used to adjust for gender and age and to evaluate the predictive ability of proposed method.
- Conditions
- Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postop pain level 1 | Minor postoperative pain anticipated | |
| Postop pain level 2 | Might experience postoperative pain | |
| Postop pain level 3 | Moderate pain/substantial surgery performed | |
| Postop pain level 4 | Severe postoperative pain expected/major surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum postoperative pain intensity (0.0-10.0 VAS units)
Patients scoring their pain associated with venous cannulation to <2 VAS units will be compared to patients scoring ≥2 VAS units considering median level of maximum postoperative pain intensity.
Measured: 2 hours after surgery
Secondary outcomes (2)
Risk of developing moderate to severe postoperative pain
Proportion of patients with moderate or severe (≥4 VAS units) postoperative pain will be compared between groups of patients scoring </≥ 2 VAS units on peripheral venous cannulation.
Measured: 2 hours after surgery
Influence of gender
With logistic regression analysis investigate the potential influence of gender on the predictive ability of this test.
Measured: 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start27 Feb 2017
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna P Persson, Lund University
- Investigators
- Anna KM Persson, M.D, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982109
- Sponsor's protocol ID
- REGSKANE-625361
- Status last verified
- Apr 2019
- First submitted
- 28 Nov 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Pain From Individually Assessed Pain Intensity Levels Associated With Venous Cannulation
- ClinicalTrials.gov ID
- NCT02982109
- Acronym / sponsor ID
- REGSKANE-625361
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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.
The investigators have recently reported a relationship between pain induced by peripheral venous cannulation and postoperative pain. The purpose of this study is to validate this method of postoperative pain prediction in a larger cohort subjected to different types of surgery.
Detailed description
- The investigators will study all adult (>18 years old) patients going through surgery at the site during a defined period of time. Before induction of anesthesia participants will be asked to assess (in VAS units) the pain intensity associated with peripheral venous cannulation. The maximum level of postoperative pain intensity will be recorded in the post-anesthesia care unit.
- After the endpoint of the study, the patient records will be reviewed, and de-identified relevant data be recorded and analyzed in the Statistical Package for the Social Sciences (SPSS) software.
- Sample size assessment: In a previous study patients scoring ≥ 2.0 on venous cannulation assessed their median pain postoperatively at 5.8 VAS units compared with 2.9 in those scoring < 2.0 - corresponding to a difference in maximum postoperative pain intensity of almost three VAS units. To statistically confirm, with unpaired non-parametric tests, 80 % power (β), and 95% probability (1- α), half of that difference (1.5 VAS units) in pain intensity level between patients scoring above or below 2.0 VAS units, respectively, would require 55 patients in each group subjected to the same kind of surgery. With 4 groups of cases and controls 440 patients would need to be included. As the study is strictly observational, 600 patients will be included to make up for possible missing data.
- Statistics: The Mann-Whitney U- test will be used to compare differences in postoperative pain intensity levels, and the Pearson Chi-square test to compare proportions of patients with moderate or severe postoperative pain, in patients differing in pain scores (above or below 2.0 VAS units) on venous cannulation. Logistic regression analysis will be used to adjust for gender and age and to evaluate the predictive ability of proposed method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Postop pain level 1 | – | –Minor postoperative pain anticipated |
| Postop pain level 2 | – | –Might experience postoperative pain |
| Postop pain level 3 | – | –Moderate pain/substantial surgery performed |
| Postop pain level 4 | – | –Severe postoperative pain expected/major surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery at Hallands Hospital Halmstad
Key inclusion criteria (3 listed)
- 18-80 years old
- Scheduled for surgery in Halmstad
- Prepared for surgery in the preoperative ward or ward 71 (day-case or direct admittance)
Key exclusion criteria (2 listed)
- Inability to handle the Visual Analog Scale
- Hospitalized already before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum postoperative pain intensity (0.0-10.0 VAS units)
Time frame: 2 hours after surgery
Patients scoring their pain associated with venous cannulation to <2 VAS units will be compared to patients scoring ≥2 VAS units considering median level of maximum postoperative pain intensity.
2 secondary outcomes
Risk of developing moderate to severe postoperative pain
Time frame: 2 hours after surgery
Influence of gender
Time frame: 2 hours after surgery
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 4 Apr 2019.
- 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.
Anna KM Persson, M.D principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Lund University at 1 site in Sweden.
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 2 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 4 Apr 2019. 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 Sweden. 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. 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?
Maximum postoperative pain intensity (0.0-10.0 VAS units) (time frame: 2 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2019.