Venous Cannulation Pain to Guide Choice of Anesthetic Method

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751812
• Other study ID #: 2020-06178
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Region Halland
• Contact: Anna KM Persson, PhD, MD
• Phone: 004635-131676
• Email: anna.p.persson[@]regionhalland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: October 31, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Halland Hospital Halmstad	Halmstad	Halland

Sponsors (2)

Lead Sponsor	Collaborator
Region Halland	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients with APOP depending on venous cannulation pain	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)	Acute; within 24 hours
Primary	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).	Acute, within 1.5 hours after surgery
Secondary	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).	Acute, 24 hours and 3 months after surgery
Secondary	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)	Preoperative measurement
Secondary	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)	Acute, within 24 hours after surgery
Secondary	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)	At 3 months after surgery
Secondary	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).	At three months after surgery
Secondary	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).	Three months after surgery.
Secondary	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).	Acute; within 24 hours
Secondary	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).	Three months after surgery
Secondary	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.	Acute; within 24 hours