Venous Cannulation Pain to Guide Choice of Anesthetic Method

NCT04751812 | Completed

• 1 other identifier: 2020-06178
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Postoperative pain; Pain prediction; VCP; Venous Cannulation Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Proportion of patients with moderate-severe postoperative pain

  Acute, 24 hours and 3 months after surgery

• Association between pain catastrophizing scale and venous cannulation pain

  Preoperative measurement

• Association between pain catastrophizing and postoperative pain

  Acute, within 24 hours after surgery

• Association between pain catastrophizing and postoperative pain

  At 3 months after surgery

• Persistent postoperative pain

  At three months after surgery

Other Outcomes (1)

• Proportion of patients with APOP depending on venous cannulation pain

  Acute; within 24 hours

Study Arms (4)

High-pain Standard of care

ACTIVE COMPARATOR

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

Procedure: Standard of care

High-pain Multimodal anesthesia with opioids

EXPERIMENTAL

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

Procedure: High-pain multimodal anesthesia with opioids

Low-pain Standard of care

ACTIVE COMPARATOR

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

Procedure: Standard of care

Low-pain opioid-free

EXPERIMENTAL

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

Procedure: Low-pain opioid free

Interventions

High-pain multimodal anesthesia with opioids PROCEDURE

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.

Also known as: More extensive pain treatment

High-pain Multimodal anesthesia with opioids

Low-pain opioid free PROCEDURE

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.

Also known as: Opioid free anesthesia

Low-pain opioid-free

Standard of care PROCEDURE

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.

High-pain Standard of care; Low-pain Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Halland: lead
• Lund University: collaborator

Study Sites (1)

Halland Hospital Halmstad

Halmstad, Halland County, 30582, Sweden

Location

Related Publications (1)

• Mogianos K, Unden J, Persson A. Effect of individualized anesthesia and analgesia on postoperative pain in patients stratified for pain sensitivity: A study protocol for the PeriOPerative individualization trial randomized controlled trial. Acta Anaesthesiol Scand. 2024 Nov;68(10):1532-1540. doi: 10.1111/aas.14487. Epub 2024 Jun 27.

  PMID: 38937954 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesics, Opioid; Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anna KM Persson, PhD, MD

  Region Halland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Consultant in Anaesthesia and Intensive Care Medicine

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 12, 2021
• Study Start: March 1, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)