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

NCT ID: NCT00508092

Last Updated: 2008-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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

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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).

Conditions

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Pain, Postoperative

Keywords

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appendicectomy pain local anaesthetic nerve block Post operative pain following appendicectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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A

lanz incision appendectomy

Group Type ACTIVE_COMPARATOR

local anesthetic administration

Intervention Type PROCEDURE

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

B

lanz incision appendectomy

Group Type ACTIVE_COMPARATOR

local anesthetic administration

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Berkshire NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Jonathan K Randall, MRCS

Role: PRINCIPAL_INVESTIGATOR

Royal Berkshire NHS Foundation Trust

Simon B Middleton, FRCS

Role: STUDY_CHAIR

Royal Berkshire NHS Foundation Trust

Arnold Goede, MRCS

Role: STUDY_DIRECTOR

Royal Berkshire NHS Foundation Trust

Locations

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Royal Berkshire Hospital

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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06/Q1602/168

Identifier Type: -

Identifier Source: org_study_id