Clinical trial NCT02982109: Pain Evaluation of Venous Cannulation to Predict Postoperative Pain
Official title: Prediction of Postoperative Pain From Individually Assessed Pain Intensity Levels Associated With Venous Cannulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery at Hallands Hospital Halmstad

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 18-80 years old
* Scheduled for surgery in Halmstad
* Prepared for surgery in the preoperative ward or ward 71 (day-case or direct admittance)

Exclusion Criteria:

* Inability to handle the Visual Analog Scale
* Hospitalized already before surgery

Primary outcomes:
measure: Maximum postoperative pain intensity (0.0-10.0 VAS units)
timeFrame: 2 hours after surgery
Secondary outcomes:
measure: Risk of developing moderate to severe postoperative pain
timeFrame: 2 hours after surgery
measure: Influence of gender
timeFrame: 2 hours after surgery
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Hallands Hospital Halmstad
state: Halland
Study officials:
affiliation: Lund University
name: Anna KM Persson, M.D
role: PRINCIPAL_INVESTIGATOR
References: