Intraoperative Local Anaesthetic and Postoperative Pain

Postoperative Pain Clinical Trial

— Pain-1  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171299
• Other study ID #: 10103
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 23, 2014
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2014
• Source: Hellenic Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of MedicinesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Wound infiltration with local anaesthetic

Drug:
• Ropivacaine

Locations

Country	Name	City	State
Greece	"Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Red Cross Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	type of analgesia required postoperatively	whether more NSAIS or more opioids were required at any given day	six days	No
Primary	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	No
Secondary	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	No