Intraoperative Local Anaesthetic and Postoperative Pain

Overview

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 .

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2013

Interventions

  • Procedure: Wound infiltration with local anaesthetic
  • Drug: Ropivacaine

Arms, Groups and Cohorts

  • Experimental: intervetional group (local anaesthetic)
    • intraoperative wound infiltration with ropivacaine 10%.
  • No Intervention: control (no local anesthetic)
    • no infiltration of the wound with local anaesthetic

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Quantity and quality of the required postoperative analgesia
    • Time Frame: six days
    • Nonsteroidal antiinflamatory drugs and opioids . each day the analgesia required by the patient is recorded and classified accordingly

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hellenic Red Cross Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sophocles Lanitis, Dr. Sophocles Lanitis, M.D, PhD – Hellenic Red Cross Hospital

References

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.

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