Pain, PostoperativeNCT04751812
Venous Cannulation Pain to Guide Choice of Anesthetic Method
A study testing High-pain multimodal anesthesia with opioids and Low-pain opioid free in people with Pain, Postoperative and Pain Prediction, run by Region Halland at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Pain Prediction, Laparoscopic Surgery
- What is being tested?
- High-pain multimodal anesthesia with opioids and Low-pain opioid free
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2022to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Venous Cannulation Pain for Evaluation of Pain Sensitivity in an Attempt to Guide Pain Therapy During and Following Anesthesia
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.
Read the 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.
- Conditions
- Pain, Postoperative, Pain Prediction, Laparoscopic Surgery, Venous Cannulation Pain, Anesthesia Opioid Free
- Being tested
- High-pain multimodal anesthesia with opioids, Low-pain opioid free, Standard of care
- Keywords
- Postoperative pain, Pain prediction, VCP, Venous Cannulation Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-pain multimodal anesthesia with opioidsProcedure or surgery
Also called More extensive pain treatment
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 freeProcedure or surgery
Also called Opioid free anesthesia
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 careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High-pain Standard of care | Active comparator | Patients grading pain associated with venous cannulation >=2.0 allocated to standard treatment. Receives: Procedure: Standard of care |
| High-pain Multimodal anesthesia with opioids | Experimental | Patients grading pain associated with venous cannulation >2.0 allocated to extra treatment. Receives: 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. Receives: Procedure: Standard of care |
| Low-pain opioid-free | Experimental | Patient grading pain associated with venous cannualation to <2.0 allocated to opioid-free anesthesia. Receives: Procedure: Low-pain opioid free |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Acute, within 1.5 hours after surgery
Secondary outcomes (9)
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).
Measured: Acute, 24 hours and 3 months after surgery
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)
Measured: Preoperative measurement
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)
Measured: Acute, within 24 hours after surgery
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)
Measured: At 3 months after surgery
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).
Measured: At three months after surgery
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).
Measured: Three months after surgery.
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).
Measured: Acute; within 24 hours
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).
Measured: Three months after surgery
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.
Measured: Acute; within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Mar 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Halland
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Anna Persson, Region Halland
- Investigators
- Anna KM Persson, PhD, MD, Principal investigator, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751812
- Sponsor's protocol ID
- 2020-06178
- Status last verified
- Apr 2025
- First submitted
- 5 Feb 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38937954
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Venous Cannulation Pain for Evaluation of Pain Sensitivity in an Attempt to Guide Pain Therapy During and Following Anesthesia
- ClinicalTrials.gov ID
- NCT04751812
- Acronym / sponsor ID
- 2020-06178
- Conditions
- Pain, Postoperative, Pain Prediction, Laparoscopic Surgery, Venous Cannulation Pain, Anesthesia Opioid Free
- Keywords
- Postoperative pain, Pain prediction, VCP, Venous Cannulation Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Region HallandUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-pain Standard of care | Active comparator | Procedure: Standard of carePatients grading pain associated with venous cannulation >=2.0 allocated to standard treatment. |
| High-pain Multimodal anesthesia with opioids | Experimental | Procedure: High-pain multimodal anesthesia with opioidsPatients grading pain associated with venous cannulation >2.0 allocated to extra treatment. |
| Low-pain Standard of care | Active comparator | Procedure: Standard of carePatients grading pain associated with venous cannulation to <2.0 allocated to standard treatment. |
| Low-pain opioid-free | Experimental | Procedure: Low-pain opioid freePatient grading pain associated with venous cannualation to <2.0 allocated to opioid-free anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-pain multimodal anesthesia with opioidsAlso: More extensive pain treatmentParacetamol, 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. | Procedure or surgery | High-pain Multimodal anesthesia with opioids |
| Low-pain opioid freeAlso: Opioid free anesthesiaParacetamol, 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. | Procedure or surgery | Low-pain opioid-free |
| Standard of careParacetamol, 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. | Procedure or surgery | High-pain Standard of care, Low-pain Standard of care |
Primary outcome
Acute postoperative pain
Time frame: Acute, within 1.5 hours after surgery
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).
9 secondary outcomes
Proportion of patients with moderate-severe postoperative pain
Time frame: Acute, 24 hours and 3 months after surgery
Association between pain catastrophizing scale and venous cannulation pain
Time frame: Preoperative measurement
Association between pain catastrophizing and postoperative pain
Time frame: Acute, within 24 hours after surgery
Association between pain catastrophizing and postoperative pain
Time frame: At 3 months after surgery
Persistent postoperative pain
Time frame: At three months after surgery
Difference in persistent pain between groups.
Time frame: Three months after surgery.
Venous cannulation pain for prediction of acute postoperative pain
Time frame: Acute; within 24 hours
Venous cannulation pain for prediction of persistent postoperative pain
Time frame: Three months after surgery
Quality of recovery
Time frame: Acute; within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 38937954Mogianos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna KM Persson, PhD, MD principal investigator
Region Halland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-pain multimodal anesthesia with opioids and Low-pain opioid free in people with Pain, Postoperative and Pain Prediction, run by Region Halland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain (time frame: Acute, within 1.5 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.