Intraoperative Local Anaesthetic and Postoperative Pain (Pain-1)

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 .

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine; Procedure: Wound infiltration with local anaesthetic

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11526
    • "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervetional group (local anaesthetic); intraoperative wound infiltration with ropivacaine 10%.	Drug: Ropivacaine; Procedure: Wound infiltration with local anaesthetic
NO_INTERVENTION: control (no local anesthetic); no infiltration of the wound with local anaesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of analgesia required postoperatively	whether more NSAIS or more opioids were required at any given day	six days

Collaborators and Investigators

• Sponsor: Hellenic Red Cross Hospital

Publications and helpful links

General Publications

• 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.
• Lanitis S, Karkoulias K, Sgourakis G, Brotzakis P, Armoutides V, Karaliotas C. The late effect of intraoperative wound infiltration with local anaesthetic in surgical patients; is there any? A randomized control trial. Int J Surg. 2015 Aug;20:35-40. doi: 10.1016/j.ijsu.2015.05.053. Epub 2015 Jun 11.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (ESTIMATE): June 24, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 10103