Anesthesia Opioid Free, Laparoscopic Surgery, Pain, Postoperative, Pain Prediction, Venous Cannulation Pain
Conditions
Keywords
Postoperative pain, Pain prediction, VCP, Venous Cannulation Pain
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.
Interventions
PROCEDUREHigh-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.
PROCEDURELow-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.
PROCEDUREStandard 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.
Sponsors
Lund University
Region Halland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participant will be blinded to allocation arm. The anesthesia nurses, the anesthesiologist and the PACU-nurse will not be blinded to the intervention. The assistant nurse performing the postoperative pain assessments will be blinded to allocation group. Once the assistant nurse has performed the assessment the PACU-nurse will decide on treatment depending on allocation and specific instructions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 | Acute, within 24 hours 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). |
| 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). |
| 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). |
| 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). |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with APOP depending on venous cannulation pain | Acute; within 24 hours | 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) |
Countries
Sweden
Outcome results
None listed