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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508092
First Posted: July 27, 2007
Last Update Posted: April 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Berkshire NHS Foundation Trust
  Purpose
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.

Condition Intervention
Pain, Postoperative Procedure: local anesthetic administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study

Resource links provided by NLM:


Further study details as provided by Royal Berkshire NHS Foundation Trust:

Primary Outcome Measures:
  • Post operative pain score [ Time Frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge ]

Secondary Outcome Measures:
  • Post operative nausea and vomiting [ Time Frame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge ]

Estimated Enrollment: 75
Study Start Date: January 2007
Arms Assigned Interventions
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


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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508092


Locations
United Kingdom
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom, RG1 5AN
Sponsors and Collaborators
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
  More Information

ClinicalTrials.gov Identifier: NCT00508092     History of Changes
Other Study ID Numbers: 06/Q1602/168
First Submitted: July 26, 2007
First Posted: July 27, 2007
Last Update Posted: April 24, 2008
Last Verified: April 2008

Keywords provided by Royal Berkshire NHS Foundation Trust:
appendicectomy
pain
local anaesthetic
nerve block
Post operative pain following appendicectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents