NCT00508092

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
Last Updated

April 24, 2008

Status Verified

April 1, 2008

First QC Date

July 26, 2007

Last Update Submit

April 22, 2008

Conditions

Pain, Postoperative

Keywords

appendicectomypainlocal anaestheticnerve blockPost operative pain following appendicectomy

Outcome Measures

Primary Outcomes (1)

  • Post operative pain score

    1 hour, 4 hours, 8 hours, 24 hours and on discharge

Secondary Outcomes (1)

  • Post operative nausea and vomiting

    1 hour, 4 hours, 8 hours, 24 hours and on discharge

Study Arms (2)

A

ACTIVE COMPARATOR

lanz incision appendectomy

Procedure: local anesthetic administration

B

ACTIVE COMPARATOR

lanz incision appendectomy

Procedure: local anesthetic administration

Interventions

local anesthetic administrationPROCEDURE

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

AB

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Laparoscopic appendectomy
  • Appendectomy at time of laparotomy/other incision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Berkshire Hospital

Reading, Berkshire, RG1 5AN, United Kingdom

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jonathan K Randall, MRCS

    Royal Berkshire NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Simon B Middleton, FRCS

    Royal Berkshire NHS Foundation Trust

    STUDY CHAIR

  • Arnold Goede, MRCS

    Royal Berkshire NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

January 1, 2007

Last Updated

April 24, 2008

Record last verified: 2008-04

Locations

GB(1)