NCT02171299

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

June 11, 2014

Last Update Submit

June 23, 2014

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quantity and quality of the required postoperative analgesia

    six days

Other Outcomes (1)

  • type of analgesia required postoperatively

    six days

Study Arms (2)

intervetional group (local anaesthetic)

EXPERIMENTAL

intraoperative wound infiltration with ropivacaine 10%.

Procedure: Wound infiltration with local anaestheticDrug: Ropivacaine

control (no local anesthetic)

NO INTERVENTION

no infiltration of the wound with local anaesthetic

Interventions

Wound infiltration with local anaestheticPROCEDURE
intervetional group (local anaesthetic)
RopivacaineDRUG
intervetional group (local anaesthetic)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who could not comprehend well
  • patients who remained intubated even for one postoperative day
  • Patients who were discharged the day of the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, 11526, Greece

Location

Related Publications (2)

  • 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.

    PMID: 19672167BACKGROUND

  • 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.

    PMID: 26074287DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, LocalRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sophocles Lanitis, M.D, PhD

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 24, 2014

Study Start

September 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

GR(1)