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

This study has been completed.
Sponsor:
Information provided by:
Royal Berkshire NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00508092
First received: July 26, 2007
Last updated: April 22, 2008
Last verified: April 2008

July 26, 2007
April 22, 2008
January 2007
Not Provided
Post operative pain score [ Time Frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge ]
Same as current
Complete list of historical versions of study NCT00508092 on ClinicalTrials.gov Archive Site
Post operative nausea and vomiting [ Time Frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge ]
Same as current
Not Provided
Not Provided
 
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Pain, Postoperative
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: A
    lanz incision appendectomy
    Intervention: Procedure: local anesthetic administration
  • Active Comparator: B
    lanz incision appendectomy
    Intervention: Procedure: local anesthetic administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Not Provided
Not Provided

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00508092
06/Q1602/168
No
Not Provided
Royal Berkshire NHS Foundation Trust
Not Provided
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
Royal Berkshire NHS Foundation Trust
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP