Venous Cannulation Pain to Guide Choice of Anesthetic Method
Primary Purpose
Pain, Postoperative, Pain Prediction, Laparoscopic Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High-pain extra
Low-pain opioid free
Standard
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Postoperative pain, Pain prediction, VCP, Venous Cannulation Pain
Eligibility Criteria
Inclusion Criteria:
- Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic procedures for non-cancer surgery at Hallands´ hospital.
Exclusion Criteria:
- Inability to understand information regarding the study. Refusal to give consent. Severe cardiovascular disease. AV-block II. Chronic pain (back, shoulder, knee). Requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements.
Sites / Locations
- Halland Hospital HalmstadRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
High-pain standard
High-pain extra
Low-pain standard
Low-pain opioid-free
Arm Description
Patients grading pain associated with venous cannulation >=2.0 allocated to standard treatment.
Patients grading pain associated with venous cannulation >2.0 allocated to extra treatment.
Patients grading pain associated with venous cannulation to <2.0 allocated to standard treatment.
Patient grading pain associated with venous cannualation to <2.0 allocated to opioid-free anesthesia.
Outcomes
Primary Outcome Measures
Postoperative pain
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Postoperative pain
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Postoperative pain
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Secondary Outcome Measures
Proportion of patients with moderate-severe postoperative pain
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable). Moderate to severe pain in defined as VAS-levels ator over 4.0.
Association betweens pain catastrophizing pain and VCP
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
Correlation between values on the pain catastrophizing scale and 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
Correlation between values on the pain catastrophizing scale and 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
Correlation between values on the pain catastrophizing scale and pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Full Information
NCT ID
NCT04751812
First Posted
February 5, 2021
Last Updated
September 5, 2023
Sponsor
Region Halland
Collaborators
Lund University
1. Study Identification
Unique Protocol Identification Number
NCT04751812
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Halland
Collaborators
Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain Prediction, Laparoscopic Surgery, Venous Cannulation Pain, Anesthesia Opioid Free
Keywords
Postoperative pain, Pain prediction, VCP, Venous Cannulation Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-pain standard
Arm Type
Active Comparator
Arm Description
Patients grading pain associated with venous cannulation >=2.0 allocated to standard treatment.
Arm Title
High-pain extra
Arm Type
Experimental
Arm Description
Patients grading pain associated with venous cannulation >2.0 allocated to extra treatment.
Arm Title
Low-pain standard
Arm Type
Active Comparator
Arm Description
Patients grading pain associated with venous cannulation to <2.0 allocated to standard treatment.
Arm Title
Low-pain opioid-free
Arm Type
Experimental
Arm Description
Patient grading pain associated with venous cannualation to <2.0 allocated to opioid-free anesthesia.
Intervention Type
Procedure
Intervention Name(s)
High-pain extra
Other Intervention Name(s)
More extensive pain treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low-pain opioid free
Other Intervention Name(s)
Opioid free anesthesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Time Frame
Acute, within 1.5 hours after surgery
Title
Postoperative pain
Description
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Time Frame
Within 24 hours after surgery
Title
Postoperative pain
Description
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Time Frame
At 3 months after surgery
Secondary Outcome Measure Information:
Title
Proportion of patients with moderate-severe postoperative pain
Description
Maximum pain reported on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable). Moderate to severe pain in defined as VAS-levels ator over 4.0.
Time Frame
Acute, 24 hours and 3 months after surgery
Title
Association betweens pain catastrophizing pain and VCP
Description
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)
Time Frame
Preoperative measurement
Title
Association between pain catastrophizing and postoperative pain
Description
Correlation between values on the pain catastrophizing scale and pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Time Frame
Acute, within 1.5 hours after surgery
Title
Association between pain catastrophizing and postoperative pain
Description
Correlation between values on the pain catastrophizing scale and pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Time Frame
Within 24 hours after surgery
Title
Association between pain catastrophizing and postoperative pain
Description
Correlation between values on the pain catastrophizing scale and pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)
Time Frame
At 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic procedures for non-cancer surgery at Hallands´ hospital.
Exclusion Criteria:
Inability to understand information regarding the study. Refusal to give consent. Severe cardiovascular disease. AV-block II. Chronic pain (back, shoulder, knee). Requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna KM Persson, PhD, MD
Phone
004635-131676
Email
anna.p.persson@regionhalland.se
First Name & Middle Initial & Last Name or Official Title & Degree
Lars-Erik Dyrehag, PhD, MD
Phone
004635-131284
Email
lars-erik.dyrehag@regionhalland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna KM Persson, PhD, MD
Organizational Affiliation
Region Halland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halland Hospital Halmstad
City
Halmstad
State/Province
Halland
ZIP/Postal Code
30582
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna KM Persson, Dr
Phone
+4635131676
Email
anna.p.persson@regionhalland.se
First Name & Middle Initial & Last Name & Degree
Krister Mogianos, MD
Phone
+4635131672
Email
krister.mogianos@regionhalland.se
First Name & Middle Initial & Last Name & Degree
Krister Mogianos, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Venous Cannulation Pain to Guide Choice of Anesthetic Method
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