Research on patient satisfaction regarding postoperative analgesia following elective laparoscopic colorectal surgery
| ISRCTN | ISRCTN37315277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37315277 |
- Submission date
- 26/07/2025
- Registration date
- 30/07/2025
- Last edited
- 29/07/2025
- 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 the best ways to manage pain after keyhole (laparoscopic) bowel surgery. These types of surgeries are part of a modern approach called Enhanced Recovery After Surgery (ERAS), which helps people recover faster and with fewer complications. One important part of this approach is good pain relief, but some common painkillers like opioids (such as morphine) can cause unpleasant side effects like nausea, constipation, and drowsiness. This study will compare three different types of pain relief to see which one works best, helps people recover faster, and improves their quality of life after surgery.
Who can participate?
Adults over the age of 18 years who are scheduled for planned (elective) keyhole bowel surgery can take part. This includes surgeries like removing part of the rectum or colon. People cannot take part if they are having a different type of surgery (like rectal amputation), if their surgery changes from keyhole to open surgery during the operation, or if they are allergic to the pain medications used in the study.
What does the study involve?
Participants will receive one of three types of pain relief:
-Epidural analgesia (a type of pain relief given through a small tube in the back)
-Spinal (intrathecal) morphine (a single injection into the spine)
-A combination of painkillers given through a drip (multimodal intravenous analgesia)
People who don’t want spinal or epidural pain relief will be placed in the intravenous group. Those who agree to spinal or epidural pain relief will be randomly assigned to one of those two groups. The study will collect information about each participant’s health, the type of surgery they had, how long they stayed in hospital, any side effects, and how satisfied they were with their pain relief. Six weeks after surgery, participants will be asked to complete a short questionnaire about their quality of life.
What are the possible benefits and risks of participating?
There may not be any direct benefit to participants, but the results could help improve pain relief for future patients having this type of surgery. There are no extra risks involved in taking part, and the usual care and treatment will not be changed.
Where is the study run from?
The study is being carried out at the Clinical Hospital Centre Rijeka in Rijeka, Croatia.
When is the study starting and how long is it expected to run for?
Who is funding the study?
The study is funded by the Clinical Hospital Centre Rijeka, Croatia
Who is the main contact?
Katarina Tomulić Brusich, ktomulic@gmail.com or katarinatb@medr.uniri.hr
Mia Šestan, mia.sestan1@gmail.com
Contact information
Public, Scientific
Krešimirova 42
Rijeka
51000
Croatia
 ORCID ID |
0000-0001-6528-8648 |
|---|---|
| Phone | +385 994888256 |
| katarinatb@medri.uniri.hr |
Principal Investigator
Krešimirova 42
Rijeka
51000
Croatia
| Phone | +385 5916123516 |
|---|---|
| mia.sestan1@gmail.com |
Study information
| Study design | Prospective single-center interventional open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Safety, Efficacy |
| Participant information sheet | 47736 PIS LPSC Informirani pristanak.pdf |
| Scientific title | Patient satisfaction regarding postoperative analgesia following elective laparoscopic colorectal surgery |
| Study acronym | - |
| Study objectives | Compared to epidural analgesia, intrathecal administration of morphine (in the subarachnoid space) and multimodal intravenous analgesia are associated with faster patient recovery and, consequently, earlier discharge from the hospital, while maintaining an equally good quality of life postoperatively. |
| Ethics approval(s) |
Approved 11/10/2024, Clinical Hospital Centre Rijeka- Ethics committee (Krešimirova 42, Rijeka, 51000, Croatia; +385 51658808; Kristina.Vucinic@kbc-rijeka.hr), ref: 003-05/24-01/163 |
| Health condition(s) or problem(s) studied | Postoperative analgesia after elective laparoscopic colorectal surgery. |
| Intervention | This study will observe three patient groups: those with epidural analgesia, those with intrathecally administered morphine, and those with multimodal intravenous analgesia. Patients who refuse one of the forms of neuroaxial analgesia (subarachnoid or epidural analgesia) will be included in the multimodal intravenous analgesia group. Patients who agree to neuroaxial analgesia will be randomized into two groups using the closed envelope method. Demographic data (age, gender, height, weight, and body mass index), co-morbidities (expressed through ASA status from the preoperative anesthesiological assessment), analgesia modality, type and duration of the surgical procedure, length of hospitalization, postoperative complications/adverse effects, and mortality will be examined. Patient satisfaction with analgesia will be assessed before discharge from the hospital using a standardized questionnaire (APS-POQ-R - Revised American Pain Society Patient Outcome Questionnaire for Quality Improvement of Pain Management in Hospitalized Adults). Additionally, six weeks after the surgical procedure, we plan to assess the quality of life of patients using the standardized questionnaire Euro-Qol-5 Dimension (EQ-5D), which is the most commonly used tool for measuring health-related quality of life (HRQoL). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Patient satisfaction with analgesia measured using APS-POQ-R—Revised American Pain Society Patient Outcome Questionnaire for Quality Improvement of Pain Management in Hospitalized Adults assessed before discharge from the hospital |
| Secondary outcome measures | 1. Investigate the speed of patient recovery (length of hospital stay), measured in days. Will be assessed using patient medical charts (hospital electronic database) 2. Note potential adverse effects or complications using patient medical charts (hospital electronic database) before hospital discharge 3. Assess the quality of life six weeks after surgery and potentially link the results to the type of analgesia received by the patients, with a special focus on complications and the development of chronic pain. Will be assessed using the standardized questionnaire Euro-Qol-5 Dimension (EQ-5D), obtained via telephone communication with the principal investigator or collaborators six weeks after the surgical procedure |
| Overall study start date | 01/06/2024 |
| Completion date | 04/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Patients scheduled for elective laparoscopic bowel resection due to tumors in the colorectal region 2. All patients must be over the age of 18 years 3. Patients of both genders are eligible 4. Eligible patients must be scheduled for laparoscopic colorectal surgery, including: - Anterior resection of the rectum - Hemicolectomies |
| Key exclusion criteria | 1. Patients who are set to have rectal amputation 2. Those whose surgery changed from laparoscopic to open abdominal surgery 3. Patients who are allergic to the intravenous or local anesthetics and pain relievers outlined in the study |
| Date of first enrolment | 15/10/2024 |
| Date of final enrolment | 05/05/2025 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Rijeka
51000
Croatia
Sponsor information
Hospital/treatment centre
Department of Anesthesiology, Intensive Care and Pain Medicine, Krešimirova 42
Rijeka
51000
Croatia
| Phone | +385 51658138 |
|---|---|
| anesteziologija@kbc-rijeka.hr | |
| Website | http://kbc-rijeka.hr |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Katarina Tomulić Brusich Clinical Hospital Centre Rijeka Department of Anesthesiology, Intensive Medicine, and Pain Treatment ktomulic@gmail.com or katarinatb@medri.uniri.hr |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Croatian | 29/07/2025 | No | Yes |
Additional files
- 47736 PIS LPSC Informirani pristanak.pdf
- in Croatian
Editorial Notes
28/07/2025: Trial's existence confirmed by Clinical Hospital Centre Rijeka- Ethics committee.
