Back to resultsCombined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
local anesthetic administration
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring appendicectomy, pain, local anaesthetic, nerve block, Post operative pain following appendicectomy
Eligibility Criteria
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
Sites / Locations
- Royal Berkshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
lanz incision appendectomy
lanz incision appendectomy
Outcomes
Primary Outcome Measures
Post operative pain score
Secondary Outcome Measures
Post operative nausea and vomiting
Full Information
NCT ID
NCT00508092
First Posted
July 26, 2007
Last Updated
April 22, 2008
Sponsor
Royal Berkshire NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00508092
Brief Title
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
Official Title
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Berkshire NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
appendicectomy, pain, local anaesthetic, nerve block, Post operative pain following appendicectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
lanz incision appendectomy
Arm Title
B
Arm Type
Active Comparator
Arm Description
lanz incision appendectomy
Intervention Type
Procedure
Intervention Name(s)
local anesthetic administration
Intervention Description
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
Primary Outcome Measure Information:
Title
Post operative pain score
Time Frame
1 hour, 4 hours, 8 hours, 24 hours and on discharge
Secondary Outcome Measure Information:
Title
Post operative nausea and vomiting
Time Frame
1 hour, 4 hours, 8 hours, 24 hours and on discharge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan K Randall, MRCS
Organizational Affiliation
Royal Berkshire NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon B Middleton, FRCS
Organizational Affiliation
Royal Berkshire NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arnold Goede, MRCS
Organizational Affiliation
Royal Berkshire NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Royal Berkshire Hospital
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
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