Venous Cannulation Pain to Guide Choice of Anesthetic Method

Region Halland270 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

270

Conditions

Pain, Postoperative

Interventions

High-pain multimodal anesthesia with opioidsPROCEDURE

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.

Low-pain opioid freePROCEDURE

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.

Standard of carePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Acute, within 1.5 hours after surgery

Secondary Outcomes

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).

Time frame: Acute, 24 hours and 3 months after surgery

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)

Time frame: Preoperative measurement

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)

Time frame: Acute, within 24 hours after surgery

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)

Time frame: At 3 months after surgery

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).

Time frame: At three months after surgery

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).

Time frame: Three months after surgery.

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).

Time frame: Acute; within 24 hours

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).

Time frame: Three months after surgery

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.