Clinical trial NCT04751812: Venous Cannulation Pain to Guide Choice of Anesthetic Method
Official title: The Use of Venous Cannulation Pain for Evaluation of Pain Sensitivity in an Attempt to Guide Pain Therapy During and Following Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pain Prediction
Laparoscopic Surgery
Venous Cannulation Pain
Anesthesia Opioid Free
Keywords: Postoperative pain
Pain prediction
VCP
Venous Cannulation Pain
Lead sponsor: Region Halland
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2021-02-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute postoperative pain
timeFrame: Acute, within 1.5 hours after surgery
Secondary outcomes:
measure: Proportion of patients with moderate-severe postoperative pain
timeFrame: Acute, 24 hours and 3 months after surgery
measure: Association between pain catastrophizing scale and venous cannulation pain
timeFrame: Preoperative measurement
measure: Association between pain catastrophizing and postoperative pain
timeFrame: Acute, within 24 hours after surgery
measure: Association between pain catastrophizing and postoperative pain
timeFrame: At 3 months after surgery
measure: Persistent postoperative pain
timeFrame: At three months after surgery
measure: Difference in persistent pain between groups.
timeFrame: Three months after surgery.
measure: Venous cannulation pain for prediction of acute postoperative pain
timeFrame: Acute; within 24 hours
measure: Venous cannulation pain for prediction of persistent postoperative pain
timeFrame: Three months after surgery
measure: Quality of recovery
timeFrame: Acute; within 24 hours
Other outcomes:
measure: Proportion of patients with APOP depending on venous cannulation pain
timeFrame: Acute; within 24 hours
Locations:
city: Halmstad
country: Sweden
facility: Halland Hospital Halmstad
state: Halland
Study officials:
affiliation: Region Halland
name: Anna KM Persson, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: