Pain, Postoperative Clinical Trial
Official title:
The Use of Venous Cannulation Pain for Evaluation of Pain Sensitivity in an Attempt to Guide Pain Therapy During and Following Anesthesia
The investigators have recently shown that pain associated with peripheral venous cannulation can be used to predict the risk of postoperative pain, where patients grading their pain associated with venous cannulation (VCP) above 2.0 VAS units had 3.4 times higher risk of moderate or severe postoperative pain after laparoscopic cholecystectomy and 1.7 times higher risk in a mixed group of patients and surgeries. The aim of this study is to investigate whether pain sensitivity measurements using VCP can be used to choose anesthesia treatment protocol with the aim to lower acute postoperative pain in those with high risk. In patients with low risk we aim to lower the amount of opioids given.
Status | Recruiting |
Enrollment | 270 |
Est. completion date | October 10, 2024 |
Est. primary completion date | October 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital. Exclusion Criteria: - Inability to understand information regarding the study. Refusal to give consent. Severe cardiovascular disease. AV-block II. Requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements. |
Country | Name | City | State |
---|---|---|---|
Sweden | Halland Hospital Halmstad | Halmstad | Halland |
Lead Sponsor | Collaborator |
---|---|
Region Halland | Lund University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of patients with APOP depending on venous cannulation pain | Difference in proportion of patients experiencing moderate to severe APOP (NRS = 4.0) between pain-sensitive and pain-tolerant groups (SOC VCP=2,0 vs SOC VCP=1,9) | Acute; within 24 hours | |
Primary | Acute postoperative pain | Difference in mean APOP between groups (Opioid free vs Standard of care, Multimodal vs Standard of care). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI). | Acute, within 1.5 hours after surgery | |
Secondary | Proportion of patients with moderate-severe postoperative pain | Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI). | Acute, 24 hours and 3 months after surgery | |
Secondary | Association between pain catastrophizing scale and venous cannulation pain | Correlation between values on the pain catastrophizing scale and venous cannulation pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable) | Preoperative measurement | |
Secondary | Association between pain catastrophizing and postoperative pain | Correlation between values on the pain catastrophizing scale and postoperative pain measured on a numeric rating scale (0-10 with 0 describing no pain and 10 the worst pain imaginable) | Acute, within 24 hours after surgery | |
Secondary | Association between pain catastrophizing and postoperative pain | Correlation between values on the pain catastrophizing scale and postoperative pain measured on a numeric rating scale (0-10 with 0 describing no pain and 10 the worst pain imaginable) | At 3 months after surgery | |
Secondary | Persistent postoperative pain | Difference in occurence of persistent postoperative pain (assessed via a questionnaire as ocurring or not) comparing the pain sensitive group (VCP >2.0) and pain tolerant group (VCP<2.0). | At three months after surgery | |
Secondary | Difference in persistent pain between groups. | Difference in mean PPOP between groups (Opioid free vs Standard of care, Multimodal vs Standard of care). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI).
Multimodal vs Standard of care). Reported as difference in NRS with confidence interval (CI). |
Three months after surgery. | |
Secondary | Venous cannulation pain for prediction of acute postoperative pain | Difference in mean APOP between pain-sensitive and pain-tolerant groups (SOC VCP=2,0 vs SOC VCP=1,9). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI). | Acute; within 24 hours | |
Secondary | Venous cannulation pain for prediction of persistent postoperative pain | Difference in ocurrence of PPOP between pain-sensitive and pain-tolerant groups (SOC VCP=2,0 vs SOC VCP=1,9). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI). | Three months after surgery | |
Secondary | Quality of recovery | Difference in Quality of recovery (QoR) after 24 hr between groups (OFA vs SOC, MAO vs SOC)? QoR assessed with the QoR-15 validated questionnaire answered by the patient 24 hours post surgery. | Acute; within 24 hours |
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