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NCT Number: NCT02171299

Intraoperative Local Anaesthetic and Postoperative Pain

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 .

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece

Athens, 11526, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wound infiltration with local anaesthetic

Procedure

Ropivacaine

Drug

Primary outcomes

  1. 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

  1. 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

Other outcomes

  1. type of analgesia required postoperatively

    Time frame: six days

    whether more NSAIS or more opioids were required at any given day

Sponsors and collaborators

Lead sponsor

Hellenic Red Cross Hospital

Other

Registry information

Official study 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.

Acronym: Pain-1

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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