NCT04751812

Venous Cannulation Pain to Guide Choice of Anesthetic Method

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Region Halland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	High-pain multimodal anesthesia with opioids	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.
PROCEDURE	Low-pain opioid free	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.
PROCEDURE	Standard of care	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-10-10
• Completion: 2024-10-10
• First posted: 2021-02-12
• Last updated: 2025-04-08

Locations

1 site across 1 country: Sweden