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

April 22, 2008 updated by: Royal Berkshire NHS Foundation Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
lanz incision appendectomy
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
Active Comparator: B
lanz incision appendectomy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post operative pain score
Time Frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
1 hour, 4 hours, 8 hours, 24 hours and on discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Post operative nausea and vomiting
Time Frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
1 hour, 4 hours, 8 hours, 24 hours and on discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Berkshire NHS Foundation Trust

Investigators

  • Principal Investigator: Jonathan K Randall, MRCS, Royal Berkshire NHS Foundation Trust
  • Study Chair: Simon B Middleton, FRCS, Royal Berkshire NHS Foundation Trust
  • Study Director: Arnold Goede, MRCS, Royal Berkshire NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

July 26, 2007

First Posted (Estimate)

July 27, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2008

Last Update Submitted That Met QC Criteria

April 22, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/Q1602/168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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