Venous Cannulation Pain to Guide Choice of Anesthetic Method

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Venous Cannulation Pain for Evaluation of Pain Sensitivity in an Attempt to Guide Pain Therapy During and Following Anesthesia

Conditions
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Pain, Postoperative, Pain Prediction, Laparoscopic Surgery, Venous Cannulation Pain, Anesthesia Opioid Free

Intervention / Treatment
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* Procedure: High-pain extra
* Procedure: Low-pain opioid free
* Procedure: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic procedures for non-cancer surgery at Hallands´ hospital. Exclusion Criteria: Inability to understand information regarding the study. Refusal to give consent. Severe cardiovascular disease. AV-block II. Chronic pain (back, shoulder, knee). Requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-pain standard<br>Patients grading pain associated with venous cannulation >=2.0 allocated to standard treatment. | Procedure: Standard<br>* Paracetamol, Etoricoxib, Oxycodone, Ondansetron p.o. Betamethasone 4 mg iv. Anesthesia: Target controlled infusion (TCI) with doses of propofol and remifentanil based on age, weight and height. Oxycodone 0.1 mg/kg 30 minutes before cessation of remifentanil. Postoperative care: At pain NRS ≥ 4 - 5 mg of oxycodone i.v. Paracetamol will be administered every 6 hours. If above is not sufficient bolus Clonidine 1 µg/kg i.v.<br>|
| Experimental: High-pain extra<br>Patients grading pain associated with venous cannulation >2.0 allocated to extra treatment. | Procedure: High-pain extra<br>* Paracetamol, Etoricoxib, Oxycodone, Ondansetron po. Betamethasone 4 mg iv. Anesthesia: As standard + bolus esketamine 0.25 mg/kg iv + Clonidine 1 µg/kg i.v. Postoperative pain treatment: At pain NRS ≥ 4 - 5 mg of oxycodone i.v. Paracetamol will be administered every 6 hours. If above is not sufficient bolus Clonidine 1 µg/kg i.v.<br>* Other names: More extensive pain treatment;|
| Active Comparator: Low-pain standard<br>Patients grading pain associated with venous cannulation to <2.0 allocated to standard treatment. | Procedure: Standard<br>* Paracetamol, Etoricoxib, Oxycodone, Ondansetron p.o. Betamethasone 4 mg iv. Anesthesia: Target controlled infusion (TCI) with doses of propofol and remifentanil based on age, weight and height. Oxycodone 0.1 mg/kg 30 minutes before cessation of remifentanil. Postoperative care: At pain NRS ≥ 4 - 5 mg of oxycodone i.v. Paracetamol will be administered every 6 hours. If above is not sufficient bolus Clonidine 1 µg/kg i.v.<br>|
| Experimental: Low-pain opioid-free<br>Patient grading pain associated with venous cannualation to <2.0 allocated to opioid-free anesthesia. | Procedure: Low-pain opioid free<br>* Paracetamol, Etoricoxib, Ondansetron p.o. Betamethasone 4 mg iv. Anesthesia: Infusion Dexmedetomidin 0.2 mikrogram/kg/h iv started 5 min before induction Induction: Esketamin 0.1mg/kg + Propofol 1.5-2 mg/kg iv + rocuronium 0.5 mg/kg iv Start of surgery: Esketamin 0.1 mg/kg iv. Maintenance of anesthesia: Sevoflurane Dexmedetomidin inf 0.2 mikrogram/kg/h Esketamin inf 0.1-0.3mg/kg/h and 0.1 mg/kg adjusted after BP and HR 30 min before end of surgery Lidocaine 1 mg/kg iv Postoperative pain treatment: • Dexmedetomidin (inf 01-0.2 µg/kg/h) 4 hours postoperative If pain NRS ≧3 Esketamin 0.1mg/kg iv + Lidocain 0.5 mg/kg iv (max 4 mg/kg /4 h) If pain NRS ≧3 within 30 min after treatment above is given with Esketamin + Lidocain, 2.5 mg Oxycodone iv. is given and may be repeated.<br>* Other names: Opioid free anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable) | Acute, within 1.5 hours after surgery | 
| Postoperative pain | Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable) | Within 24 hours after surgery | 
| Postoperative pain | Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable) | At 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with moderate-severe postoperative pain | Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable). Moderate to severe pain in defined as VAS-levels ator over 4.0. | Acute, 24 hours and 3 months after surgery | 
| Association betweens pain catastrophizing pain and VCP | 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 | 
| Association between pain catastrophizing and postoperative pain | Correlation between values on the pain catastrophizing scale and pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable) | Acute, within 1.5 hours after surgery | 
| Association between pain catastrophizing and postoperative pain | Correlation between values on the pain catastrophizing scale and pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable) | Within 24 hours after surgery | 
| Association between pain catastrophizing and postoperative pain | Correlation between values on the pain catastrophizing scale and pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable) | At 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VCP, Postoperative pain, Pain prediction, Venous Cannulation Pain