HEpatic Resection Analgesia and Length of time to Discharge

ISRCTN	ISRCTN16147723
DOI	https://doi.org/10.1186/ISRCTN16147723
Secondary identifying numbers	17760

Submission date: 28/01/2015
Registration date: 28/01/2015
Last edited: 22/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ben Clevenger
Scientific

Department of Anaesthesia
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

ORCID ID	0000-0001-5659-6323
Phone	+44 (0)20 7794 0500 Ext: 24534
Email	b.clevenger@nhs.net

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Short-term outcomes with intrathecal opioid and patient controlled analgesia versus thoracic epidural analgesia for hepatic resection: a randomised controlled trial
Study acronym	HERALD1
Study objectives	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(s)	MREC approval date 09/10/2014, ref: 14/LO/1174
Health condition(s) or problem(s) studied	Hepatic resection
Intervention	Patients will be randomised to either thoracic epidural analgesia or intrathecal diamorphine with Fentanyl PCA.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
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 study start date	01/12/2014
Completion date	01/01/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 98; UK Sample Size: 98
Total final enrolment	98
Key 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
Key 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
Date of first enrolment	01/12/2014
Date of final enrolment	01/10/2019

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Free Hospital

Pond Street
London
NW3 2QG
United Kingdom

Sponsor information

University College London
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute of Academic Anaesthesia
Government organisation / Local government

Alternative name(s): NIAA
Location: United Kingdom

Royal Free Charity (UK)

No information available

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	01/08/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high impact peer-reviewed journal.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

22/04/2021: The intention to publish date has been changed from 01/01/2021 to 01/08/2021.
07/01/2020: The following changes have been made:
1. The intention to publish date has been changed from 01/04/2021 to 01/01/2021.
2. The overall trial end date has been changed from 01/04/2020 to 01/01/2020.
3. The total final enrolment number has been added.
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.