Condition category
Cancer
Date applied
28/01/2015
Date assigned
28/01/2015
Last edited
17/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susan Mallett

ORCID ID

Contact details

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17760

Study information

Scientific title

Short-term outcomes with intrathecal opioid and patient controlled analgesia versus thoracic epidural analgesia for hepatic resection: a randomised controlled trial

Acronym

HERALD1

Study hypothesis

Hepatic resection is an operation where the part of the liver containing cancer is removed. Pain relief plays an important part in the patient’s recovery following this type of surgery, with the potential to improve patient outcomes. This study will provide high quality evidence as to whether the choice of pain relief affects the length of time that patients take to recover from hepatic resection surgery. Showing the use of either spinal or epidural analgesia to be associated with better outcomes including time until medically fit for discharge will ensure that the most effective form of analgesia is used for this surgery.

Ethics approval

MREC approval date 09/10/2014, ref: 14/LO/1174

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Anaesthesia, perioperative medicine and pain management, Hepatology; Subtopic: Anaesthesia, perioperative medicine and pain management, Hepatology; Disease: All Anaesthesia, perioperative medicine and pain management, All Hepatology

Intervention

Analgesic modality
Patients will be randomised to either thoracic epidural analgesia or intrathecal diamorphine with Fentanyl PCA

Intervention type

Drug

Phase

Drug names

Primary outcome measures

Length of stay until medically fit for discharge; Timepoint(s): Time until medically fit for discharge post operatively

Secondary outcome measures

N/A

Overall trial start date

01/12/2014

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consent for enrolment
2. Patients presenting for elective one-stage open Hepatic Resection surgery at the Royal Free Hospital, London
3. Patients receiving a midline +/- a transverse incision in the right upper quadrant (‘reverse L incision’)
4. No contraindication to, or refusal to receive, central neuraxial block (epidural or spinal analgesia)
5. Aged at least 16

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 98; UK Sample Size: 98

Participant exclusion criteria

1. Adult unable to give informed consent
2. Allergy to local anaesthetics
3. Infection around the potential puncture site
4. Coagulation disorders (INR >1.5, platelets <100 x 10(9))
5. Chronic pain, requiring opioid analgesia or illicit opioid use
6. Mobility problems requiring assistance

Recruitment start date

01/12/2014

Recruitment end date

01/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute of Academic Anaesthesia (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Free Charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes