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
01/01/2020
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
Total final enrolment
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
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
01/01/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list