Comparing pain relief methods for keyhole bowel surgery: A study on two types of nerve blocks
| ISRCTN | ISRCTN36371400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36371400 |
- Submission date
- 18/11/2024
- Registration date
- 25/11/2024
- Last edited
- 25/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study aims to compare two pain relief methods used after keyhole bowel surgery. The goal is to find the most effective way to reduce pain and minimize the need for morphine, which can have side effects. The two methods being compared are the quadratus lumborum (QL) block and the transversus abdominis plane (TAP) block.
Who can participate?
Patients who are undergoing laparoscopic (keyhole) colorectal surgery can participate in this study.
What does the study involve?
Participants will be randomly assigned to one of two groups: one group will receive the QL block, and the other will receive the TAP block. Both groups will receive general anesthesia during surgery. After the surgery, participants will receive one of the two pain relief methods. All participants will also receive standard pain relief medications, including paracetamol, nefopam, and patient-controlled analgesia (PCA).
What are the possible benefits and risks of participating?
Participants may benefit from effective pain relief from one of the two methods. Both methods have been shown to reduce pain after laparoscopic colorectal surgery. There is a very small risk of complications related to anesthesia, but these are rare and will be closely monitored by medical staff.
Where is the study run from?
Binh Dan Hospital (Viet Nam)
When is the study starting and how long is it expected to run for?
July 2024 to September 2025
Who is funding the study?
University of Medicine and Pharmacy at Ho Chi Minh City Medicine and Pharmacy University (Viet Nam)
Who is the main contact?
Mr Van Phuoc Toan, dr.toanvan@gmail.com
Contact information
Public, Scientific, Principal Investigator
371 Dien Bien Phu - Ward 4 - District 3
Ho Chi Minh
700000
Viet Nam
 ORCID ID |
0009-0009-6233-0826 |
|---|---|
| Phone | +84 902993591 |
| dr.toanvan@gmail.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Efficacy |
| Scientific title | Comparison of analgesic efficacy between quadratus lumborum block and transversus abdominal plane block in laparoscopic colorectal surgery |
| Study objectives | Quadratus lumborum anesthesia reduces morphine consumption 48 hours postoperatively by 50% compared with transverse abdominal plane anesthesia in laparoscopic colorectal surgery |
| Ethics approval(s) |
Approved 22/10/2024, Ethics council in biomedical research, University of Medicine and Pharmacy (217 Hong Bang, Ward 11, District 5, Hochiminh city, 700000, Viet Nam; +84 28 3855 0507; hoidongdaoducdhyd@ump.edu.vn), ref: IRB-VN01002/IRB00010293/FWA00023448 |
| Health condition(s) or problem(s) studied | Analgesic after laparoscopic colorectal surgery |
| Intervention | All patients recruited into the study will be randomized into 2 groups: GL group (quadra lumbar muscle block group) and TAP group (transversus abdominis plane block group) by creating a block random number table in Excel software 2016 (copyrighted by the Department of Public Health - Ho Chi Minh City University of Medicine and Pharmacy). Choosing the RAND function with the sort A->Z command will give you similar random numbers corresponds to the serial number of the patients in the research sample. Choose an odd number QL group and even numbers for TAP group. The patient is induced, intubated and maintained according to the protocol hospital. At the end of surgery: After the last stitch of skin is sutured, the patient is fine perform QL or TAP according to initial randomization. Both methods are performed under ultrasound guidance. The anesthetic used is ropivacaine 0.25% 20ml for each side. Post-operative analgesia includes: patient-controlled analgesia (PCA) with morphine, paracetamol 1gr per 8h, nefopam 20mg per 8h. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Total dose of morphine-PCA 48 hours after surgery measured using patient records |
| Secondary outcome measures | Measured using patient records: 1. Total dose of morphine-PCA at postoperative time points (1 hour, 2 hours, 6 hours, 12 hours, 24 hours) 2. VAS pain scores at rest and movement at postoperative times (1 hour, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours) 3. Postoperative nausea and vomiting (PONV) 4. Opioid sedation (POSS) 5. Abdominal skin sensory area after 1 hour of blockade. |
| Overall study start date | 01/07/2024 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Resident |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. The patient is indicated for elective laparoscopic colorectal surgery 2. Patients are 18 to 70 years old 3. Patients' health status is assessed according to the Society of Anesthesiology and Resuscitation United States (ASA) at level I-III |
| Key exclusion criteria | 1. Patients addicted to opioid drugs 2. Do not understand the instructions for using the PCA device 3. History of chronic pain, anesthetic allergy 4. Obese patients have BMI over 30 kg/m² 5. The patient converted from laparoscopic surgery to open surgery |
| Date of first enrolment | 11/11/2024 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Hochiminh city
700000
Viet Nam
Sponsor information
Hospital/treatment centre
371 Dien Bien Phu - Ward 4 - District 3
Ho Chi Minh
700000
Viet Nam
| Phone | +84 28 3839 4747 |
|---|---|
| bvbinhdan@hcm.vnn.vn | |
| Website | https://bvbinhdan.com.vn/ |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| 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 are available from the corresponding author on reasonable request hoinghibvbd@gmail.com dr.toanvan@gmail.com |
Editorial Notes
25/11/2024: Trial's existence confirmed by Ethics council in biomedical research, University of Medicine and Pharmacy.
