Intraoperative Local Anaesthetic and Postoperative Pain

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Wound infiltration with local anaesthetic; Drug: Ropivacaine

• Registration Number: NCT02171299
• Lead Sponsor: Hellenic Red Cross Hospital

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-23
• Last Update Submitted: 2014-06-23
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervetional group (local anaesthetic)	Wound infiltration with local anaesthetic	intraoperative wound infiltration with ropivacaine 10%.
intervetional group (local anaesthetic)	Ropivacaine	intraoperative wound infiltration with ropivacaine 10%.

Primary Outcome Measures

Name	Time	Method
Intensity of postoperative pain	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 Outcome Measures

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

Trial Locations

Locations (1)

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