Intraoperative Local Anaesthetic and Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intervetional group (local anaesthetic)

intraoperative wound infiltration with ropivacaine 10%.

Group Type EXPERIMENTAL

Wound infiltration with local anaesthetic

Intervention Type PROCEDURE

Ropivacaine

Intervention Type DRUG

control (no local anesthetic)

no infiltration of the wound with local anaesthetic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wound infiltration with local anaesthetic

Intervention Type PROCEDURE

Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No