Venous Cannulation Pain to Guide Choice of Anesthetic Method

Region Halland

Status: Completed

Conditions: Laparoscopic Surgery; Anesthesia Opioid Free; Pain, Postoperative; Pain Prediction; Venous Cannulation Pain

Treatments: Procedure: Standard of care; Procedure: Low-pain opioid free; Procedure: High-pain multimodal anesthesia with opioids

Study type: Interventional

Funder types: Other

Identifiers

NCT04751812

2020-06178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 4 patient groups

High-pain Standard of care

Active Comparator group

Description:

Patients grading pain associated with venous cannulation \>=2.0 allocated to standard treatment.

Treatment:

Procedure: Standard of care

High-pain Multimodal anesthesia with opioids

Experimental group

Description:

Patients grading pain associated with venous cannulation \>2.0 allocated to extra treatment.

Treatment:

Procedure: High-pain multimodal anesthesia with opioids

Low-pain Standard of care

Active Comparator group

Description:

Patients grading pain associated with venous cannulation to \<2.0 allocated to standard treatment.

Treatment:

Procedure: Standard of care

Low-pain opioid-free

Experimental group

Description:

Patient grading pain associated with venous cannualation to \<2.0 allocated to opioid-free anesthesia.

Treatment:

Procedure: Low-pain opioid free