Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study

Pain, Postoperative Clinical Trial

Official title:

Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508092
• Other study ID #: 06/Q1602/168
• Status: Completed
• Phase: N/A
• First received: July 26, 2007
• Last updated: April 22, 2008
• Start date: January 2007

Study information

• Verified date: April 2008
• Source: Royal Berkshire NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether the use of local anesthetic to numb the nerves that run deeper in the abdominal wall gives better post operative pain control than just infiltrating local anesthetic to the wound edges.

Description:

Local anesthetic is often administered during an operation to reduce post operative wound pain. Whilst this is frequently done during an appendectomy there is currently no evidence to suggest whether there is any benefit to the patient to injecting the local anesthetic deeper to block the nerves supplying abdominal wall sensation, compared to using it just in the skin around the wound.

Comparison: Post operative pain scores following appendectomy for patients given skin infiltration of local anesthetic (pre incision), compared to patients given both preincision wound infiltration and deeper field infiltration with local anesthetic(deep to external oblique).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Lanz incision appendectomy as starting procedure, including those where an alternative cause for symptoms is found at operation and those where incision is later extended/changed (these may be sub grouped at time of analysis)

• Consent obtained

Exclusion Criteria:

• Laparoscopic appendectomy

• Appendectomy at time of laparotomy/other incision

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• local anesthetic administration
Pre incision skin infiltration with local anesthetic 0.5% bupivacaine by weight OR Pre incision skin infiltration and deeper field infiltration (deep to external oblique) with local anesthetic 0.5% bupivavcaine by weight

Locations

Country	Name	City	State
United Kingdom	Royal Berkshire Hospital	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
Royal Berkshire NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain score		1 hour, 4 hours, 8 hours, 24 hours and on discharge
Secondary	Post operative nausea and vomiting		1 hour, 4 hours, 8 hours, 24 hours and on discharge