HEpatic Resection Analgesia and Length of time to Discharge
| ISRCTN | ISRCTN16147723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16147723 |
| Protocol serial number | 17760 |
| Sponsor | University College London |
| Funders | National Institute of Academic Anaesthesia, Royal Free Charity (UK), National Institute for Health Research |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
| b.clevenger@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Length of stay until medically fit for discharge; Timepoint(s): Time until medically fit for discharge post operatively |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 01/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
London
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
