Clinical Trial Comparing Epidurals and Local Anaesthetic Wound Catheters in Patients Having Bowel Surgery

NCT ID: NCT01279980

Last Updated: 2011-02-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to find out whether the use of Painbuster® (a local anaesthetic wound catheter) can be used instead of epidurals for patients having bowel surgery in an enhanced recovery programme. The investigators want to find out whether or not using this device means people need to stay in hospital for less time after surgery.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural

Subjects will have an epidural catheter placed to provide postoperative pain relief. This is standard care for those undergoing an enhanced recovery program.

Group Type ACTIVE_COMPARATOR

Epidural

Intervention Type OTHER

Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day

Painbuster

Subjects will have a local anaesthetic wound catheter inserted into the wound at time of surgery rather than an epidural for the provision of postoperative pain relief.

Group Type ACTIVE_COMPARATOR

Local anaesthetic wound catheter

Intervention Type OTHER

The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.

Interventions

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Epidural

Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day

Intervention Type OTHER

Local anaesthetic wound catheter

The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.

Intervention Type OTHER

Other Intervention Names

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Painbuster(registered trademark)

Eligibility Criteria

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Inclusion Criteria

* All patients who are undergoing either laparoscopic or open colorectal resection will be considered eligible for the study.

Exclusion Criteria

* Patients under 18 years of age
* Pregnant females
* Patients undergoing an abdominoperineal resection
* Patients unable to understand English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scarborough General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Scarborough General Hospital

Principal Investigators

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Eleanor R Richards, BM Medicine

Role: PRINCIPAL_INVESTIGATOR

Scarborough General Hospital

Locations

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Scarborough General Hospital

Scarborough, North Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Eleanor R Richards, BM Medicine

Role: CONTACT

0044723368111 ext. 5324

Facility Contacts

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Mark Andrews, (Medical director)

Role: primary

00441723368111

Other Identifiers

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10/H1308/63

Identifier Type: -

Identifier Source: org_study_id

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