Intraoperative Local Anaesthetic and Postoperative Pain (Pain-1)

Hellenic Red Cross Hospital

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine; Procedure: Wound infiltration with local anaesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT02171299

10103

Details and patient eligibility

About

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 .

Enrollment: 400 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

intervetional group (local anaesthetic)

Experimental group

Description:

intraoperative wound infiltration with ropivacaine 10%.

Treatment:

Procedure: Wound infiltration with local anaesthetic

Drug: Ropivacaine

control (no local anesthetic)

No Intervention group

Description:

no infiltration of the wound with local anaesthetic