Postoperative PainPain-1NCT02171299
Intraoperative Local Anaesthetic and Postoperative Pain
A study testing Wound infiltration with local anaesthetic and Ropivacaine in people with Postoperative Pain, run by Hellenic Red Cross Hospital at 1 site in Greece.
Trial summary
Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Wound infiltration with local anaesthetic and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2012to Feb 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with conditions that require surgery ( general surgery)
- Must be able to comprehent the questions , fill documents, communicate well with the doctors
- Patients who will have at least one surgical incision under general or regional anaesthesia
Who cannot join
- Patients who could not comprehend well
- patients who remained intubated even for one postoperative day
- Patients who were discharged the day of the operation
Trial locations and contacts
1 site in 1 country.
Greece1 site
"Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece
Athens, 11526
About this study
Official title: Intraoperative Wound Infiltration With Local Anaesthetic in Surgical Patients; Is There Any Late Effect on the Postoperative Pain and the Requirements of Analgesia ? A Randomized Control Trial.
Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. Our aim was to compare the use of local anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.
Materials and methods: We will conduct a RCT involving 400 consecutive general surgery patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as well as the type and quantity of the analgesia used during the study period.
Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic have lower pain during the 1st postoperative week and require less pain killers .
- Conditions
- Postoperative Pain
- Being tested
- Wound infiltration with local anaesthetic, Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound infiltration with local anaestheticProcedure or surgery
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| intervetional group (local anaesthetic) | Experimental | intraoperative wound infiltration with ropivacaine 10%. Receives: Procedure: Wound infiltration with local anaesthetic; Drug: Ropivacaine |
| control (no local anesthetic) | No intervention | no infiltration of the wound with local anaesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain
the intensity of the pain will be assessed using the : The visual analogue scale (VAS) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) and (2) the numeric rating scale (NRS) which is a segmented numeric version of the visual analog scale (VAS) in which the patient indicates the number (0-10) that best reflects the intensity of their pain. Both tests are easy to obtain, reliable, valid and can detect changes of over time
Measured: six days
Secondary outcomes (1)
Quantity and quality of the required postoperative analgesia
Nonsteroidal antiinflamatory drugs and opioids . each day the analgesia required by the patient is recorded and classified accordingly
Measured: six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophocles Lanitis, Hellenic Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171299
- Sponsor's protocol ID
- 10103
- Acronym
- Pain-1
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PubMed 19672167Lanitis S, Karkoulias K, Sgourakis G, Brotzakis P, Armoutides V, Karaliotas C. The late effect of intraoperative wound infiltration with local anaesthetic in surgical patients; is there any? A randomized control trial. Int J Surg. 2015 Aug;20:35-40. doi: 10.1016/j.ijsu.2015.05.053. Epub 2015 Jun 11.
PubMed 26074287
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Wound Infiltration With Local Anaesthetic in Surgical Patients; Is There Any Late Effect on the Postoperative Pain and the Requirements of Analgesia ? A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT02171299
- Acronym / sponsor ID
- Pain-1 / 10103
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hellenic Red Cross HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Jun 2014 (estimated)
- 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.
Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. Our aim was to compare the use of local anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.
Materials and methods: We will conduct a RCT involving 400 consecutive general surgery patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as well as the type and quantity of the analgesia used during the study period.
Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic have lower pain during the 1st postoperative week and require less pain killers .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervetional group (local anaesthetic) | Experimental | Procedure: Wound infiltration with local anaesthetic, Drug: Ropivacaineintraoperative wound infiltration with ropivacaine 10%. |
| control (no local anesthetic) | No intervention | –no infiltration of the wound with local anaesthetic |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with conditions that require surgery ( general surgery)
- Must be able to comprehent the questions , fill documents, communicate well with the doctors
- Patients who will have at least one surgical incision under general or regional anaesthesia
Key exclusion criteria (3 listed)
- Patients who could not comprehend well
- patients who remained intubated even for one postoperative day
- Patients who were discharged the day of the operation
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 |
|---|---|---|
| Wound infiltration with local anaesthetic | Procedure or surgery | intervetional group (local anaesthetic) |
| Ropivacaine | Drug | intervetional group (local anaesthetic) |
Primary outcome
Intensity of postoperative pain
Time frame: six days
the intensity of the pain will be assessed using the : The visual analogue scale (VAS) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) and (2) the numeric rating scale (NRS) which is a segmented numeric version of the visual analog scale (VAS) in which the patient indicates the number (0-10) that best reflects the intensity of their pain. Both tests are easy to obtain, reliable, valid and can detect changes of over time
1 secondary outcome
Quantity and quality of the required postoperative analgesia
Time frame: six days
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 24 Jun 2014.
- Background: PubMed 19672167Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
- Derived from this study: PubMed 26074287Lanitis S, Karkoulias K, Sgourakis G, Brotzakis P, Armoutides V, Karaliotas C. The late effect of intraoperative wound infiltration with local anaesthetic in surgical patients; is there any? A randomized control trial. Int J Surg. 2015 Aug;20:35-40. doi: 10.1016/j.ijsu.2015.05.053. Epub 2015 Jun 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound infiltration with local anaesthetic and Ropivacaine in people with Postoperative Pain, run by Hellenic Red Cross Hospital at 1 site in Greece.
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 3 inclusion and 3 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 24 Jun 2014. 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 Greece. 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?
Intensity of postoperative pain (time frame: six days). 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 NCT02171299, which also lists 2 linked publications.
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 24 Jun 2014.