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.
Overview
- Phase
- N/A
- Intervention
- Wound infiltration with local anaesthetic
- Conditions
- Postoperative Pain
- Sponsor
- Hellenic Red Cross Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Intensity of postoperative pain
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 .
Investigators
Sophocles Lanitis
Dr. Sophocles Lanitis, M.D, PhD
Hellenic Red Cross Hospital
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
Arms & Interventions
intervetional group (local anaesthetic)
intraoperative wound infiltration with ropivacaine 10%.
Intervention: Wound infiltration with local anaesthetic
intervetional group (local anaesthetic)
intraoperative wound infiltration with ropivacaine 10%.
Intervention: Ropivacaine
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Quantity and quality of the required postoperative analgesia(six days)