Pain relief provided by a caudal epidural following robotic surgery removing the prostate while under general anaesthesia
| ISRCTN | ISRCTN86549389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86549389 |
| Secondary identifying numbers | CA 3049 |
- Submission date
- 28/04/2025
- Registration date
- 29/04/2025
- Last edited
- 29/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study is looking at how effective a pain-relieving injection, called a caudal block, is for patients having robotic-assisted surgery to remove the prostate gland. The aim is to see if this injection can help reduce pain after the surgery and lessen the need for stronger painkillers like morphine.
Who can participate?
Patients who are scheduled to have robotic-assisted prostate surgery at Galway University Hospital can participate in this study.
What does the study involve?
Participants will be randomly divided into two groups. One group will receive the standard pain relief methods, while the other group will receive an additional caudal block injection. This injection is given while the patient is under general anaesthetic and helps numb the lower half of the body.
What are the possible benefits and risks of participating?
The possible benefits include better pain relief after surgery and a quicker recovery. The risks are minimal but may include side effects from the caudal block, such as temporary numbness or discomfort.
Where is the study run from?
Galway University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
June 2023 to December 2023.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Eoin Coughlan, eoin645@outlook.com
Patrick O'Malley, paddyomalley@hotmail.com
Dr Patrick Neligan, pjneligan@yahoo.com
Contact information
Public, Scientific
Apt 31, Merton Hall
Milltown Avenue, Mount St Annes
Dublin 6
D06 DX00
Ireland
 ORCID ID |
0009-0007-3482-0698 |
|---|---|
| Phone | +353 851646017 |
| eoin645@outlook.com |
Principal Investigator
Galway University Hospital
Galway
H91 YR71
Ireland
| Phone | +353 874194709 |
|---|---|
| paddyomalley@hotmail.com |
Principal Investigator
Galway University Hospital
Galway
H91 YR71
Ireland
| Phone | +353 879687096 |
|---|---|
| pjneligan@yahoo.com |
Study information
| Study design | Randomised single-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Analgesic requirements following caudal epidural in elective robotic prostatectomy |
| Study objectives | Caudal epidural decreases post-operative opioid analgesic requirements in robotic prostatectomy as opposed to protocolled multimodal analgesia alone |
| Ethics approval(s) |
Approved 06/07/2023, Galway University Hospital Ethics Committee (Newcastle Road, Galway, H91 YR71, Ireland; +353 91524222; consumeraffairs.west@hse.ie), ref: CA 3049 |
| Health condition(s) or problem(s) studied | Robotic prostatectomy |
| Intervention | General anaesthesia for the procedure will be standardised and include the administration of abdominal wall blocks and morphine. The study intervention is to administer an additional caudal epidural block to patients randomised into the intervention group. The patients who are administered standard anaesthesia will henceforth be called the ‘control’ group. Candidates will be randomised into 2 groups. This will be done by the last digit of the patient’s board number. The candidates with an even final digit of their board number will be considered for caudal block. The candidates with an odd final digit will not be given a caudal block. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Cumulative opioid consumption in the 24 hour post-operative period measured using patient records |
| Secondary outcome measures | 1. Pain (visual analogue) score at 2, 4, 6, and 24 hours post-procedure 2. Cumulative requirements for anti-emetic therapy in the first 24 hours post-operatively 3. Richmond Agitation-Sedation Score at 2, 4, 6, and 24 hours post-procedure |
| Overall study start date | 01/06/2023 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 90 Years |
| Sex | Male |
| Target number of participants | 75 |
| Total final enrolment | 70 |
| Key inclusion criteria | Those undergoing elective radical robotic prostatectomy |
| Key exclusion criteria | 1. Participant refusal 2. Treatment for chronic pain 3. Psychiatric illness 4. Local pathology of the spine |
| Date of first enrolment | 12/06/2023 |
| Date of final enrolment | 13/12/2023 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Galway
H91 YR71
Ireland
Sponsor information
University/education
Newcastle Road
Galway
H91 YR71
Ireland
| Phone | +353 91524222 |
|---|---|
| consumeraffairs.west@hse.ie | |
| Website | https://www.universityofgalway.ie |
"ROR" |
https://ror.org/03bea9k73 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and / or analysed during the current study will be available upon request from Eoin Coughlan - eoin645@outlook.com |
Editorial Notes
29/04/2025: Trial's existence confirmed by Galway University Hospital Ethics Committee.
