Intraoperative Local Anaesthetic and Postoperative Pain (Pain-1)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Wound infiltration with local anaesthetic
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who could not comprehend well
- patients who remained intubated even for one postoperative day
- Patients who were discharged the day of the operation
Sites / Locations
- "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervetional group (local anaesthetic)
control (no local anesthetic)
Arm Description
intraoperative wound infiltration with ropivacaine 10%.
no infiltration of the wound with local anaesthetic
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02171299
First Posted
June 11, 2014
Last Updated
June 23, 2014
Sponsor
Hellenic Red Cross Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02171299
Brief Title
Intraoperative Local Anaesthetic and Postoperative Pain
Acronym
Pain-1
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hellenic Red Cross Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervetional group (local anaesthetic)
Arm Type
Experimental
Arm Description
intraoperative wound infiltration with ropivacaine 10%.
Arm Title
control (no local anesthetic)
Arm Type
No Intervention
Arm Description
no infiltration of the wound with local anaesthetic
Intervention Type
Procedure
Intervention Name(s)
Wound infiltration with local anaesthetic
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
Intensity of postoperative pain
Description
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
Time Frame
six days
Secondary Outcome Measure Information:
Title
Quantity and quality of the required postoperative analgesia
Description
Nonsteroidal antiinflamatory drugs and opioids . each day the analgesia required by the patient is recorded and classified accordingly
Time Frame
six days
Other Pre-specified Outcome Measures:
Title
type of analgesia required postoperatively
Description
whether more NSAIS or more opioids were required at any given day
Time Frame
six days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients who could not comprehend well
patients who remained intubated even for one postoperative day
Patients who were discharged the day of the operation
Facility Information:
Facility Name
"Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece
City
Athens
ZIP/Postal Code
11526
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
19672167
Citation
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.
Results Reference
background
PubMed Identifier
26074287
Citation
Lanitis 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.
Results Reference
derived
Learn more about this trial
Intraoperative Local Anaesthetic and Postoperative Pain
We'll reach out to this number within 24 hrs