Postoperative Pain Clinical Trial
— Pain-1Official 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 .
Status | Completed |
Enrollment | 400 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece | Athens |
Lead Sponsor | Collaborator |
---|---|
Hellenic Red Cross Hospital |
Greece,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | type of analgesia required postoperatively | whether more NSAIS or more opioids were required at any given day | six days | No |
Primary | 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 | six days | No |
Secondary | 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 | six days | No |
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