Condition category
Surgery
Date applied
28/01/2015
Date assigned
28/01/2015
Last edited
11/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ben Clevenger

ORCID ID

http://orcid.org/0000-0001-5659-6323

Contact details

Department of Anaesthesia
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
+44 (0)20 7794 0500 Ext: 24534
b.clevenger@nhs.net

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

Hepatic resection

Intervention

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Primary outcome measure

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

01/04/2020

Reason abandoned (if study stopped)

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

01/10/2019

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

Alternative name(s)

NIAA

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

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

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer-reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/07/2019: The following changes were made to the trial record: 1. Study contact updated. 2. The recruitment end date was changed from 01/11/2015 to 01/10/2019. 3. The overall trial end date was changed from 01/11/2015 to 01/04/2020. 4. Publication and dissemination plan and IPD sharing statement added. 07/12/2017: No publications found, verifying study status with principal investigator.