Venous Cannulation Pain to Guide Choice of Anesthetic Method
- Conditions
- Venous Cannulation PainPain, PostoperativePain PredictionLaparoscopic SurgeryAnesthesia Opioid Free
- Interventions
- Procedure: Standard of careProcedure: Low-pain opioid freeProcedure: High-pain multimodal anesthesia with opioids
- Registration Number
- NCT04751812
- Lead Sponsor
- Region Halland
- Brief Summary
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.
- Detailed Description
The investigators will perform a randomized controlled trial randomizing patients to different treatment protocols depending on their pain associated with venous cannulation. There will be two set of instructions for perioperative treatment, one for those grading pain associated with venous cannulation \<2.0 (low-pain) and another for those grading VCP ≥2.0 (high-pain).
The low-pain group will be randomized to standard treatment or opioid-free anesthesia. The high-pain group will be randomized to standard treatment or extra in form of additives like esketamine and clonidine.
In the low-pain group the investigators aim for non-inferiority with the gain being avoiding opioids. In the high-pain group the investigators aim for lower post-operative pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-pain Standard of care Standard of care Patients grading pain associated with venous cannulation \>=2.0 allocated to standard treatment. Low-pain Standard of care Standard of care Patients grading pain associated with venous cannulation to \<2.0 allocated to standard treatment. Low-pain opioid-free Low-pain opioid free Patient grading pain associated with venous cannualation to \<2.0 allocated to opioid-free anesthesia. High-pain Multimodal anesthesia with opioids High-pain multimodal anesthesia with opioids Patients grading pain associated with venous cannulation \>2.0 allocated to extra treatment.
- Primary Outcome Measures
Name Time Method Acute postoperative pain Acute, within 1.5 hours after surgery 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).
- Secondary Outcome Measures
Name Time Method Proportion of patients with moderate-severe postoperative pain Acute, 24 hours and 3 months after surgery 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).
Venous cannulation pain for prediction of acute postoperative pain Acute; within 24 hours 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).
Difference in persistent pain between groups. Three months after surgery. 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).Quality of recovery Acute; within 24 hours 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.
Association between pain catastrophizing scale and venous cannulation pain Preoperative measurement 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)
Association between pain catastrophizing and postoperative pain At 3 months after surgery 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)
Persistent postoperative pain At three months after surgery 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).
Venous cannulation pain for prediction of persistent postoperative pain Three months after surgery 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).
Trial Locations
- Locations (1)
Halland Hospital Halmstad
🇸🇪Halmstad, Halland, Sweden