Double-sided back muscle numbing for pain relief pain after having the gallbladder removed using keyhole surgery
| ISRCTN | ISRCTN18151624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18151624 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 08012021 |
| Sponsor | Universidad del Sinú |
| Funder | Universidad del Sinú |
- Submission date
- 16/09/2023
- Registration date
- 21/09/2023
- Last edited
- 21/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Laparoscopic cholecystectomy is a specific type of surgery where the gallbladder is removed using small incisions and a camera. An erector spinae block is a medical procedure in which a local anesthetic (a medication that numbs sensation) is injected near the erector spinae muscles along the spine. This is done to block or numb the nerves that transmit pain signals from the surgical area to the brain. The purpose of using this block is to provide effective pain relief during and after the surgery. By numbing the nerves in the area, it helps reduce the amount of pain the patient feels, making the surgical procedure more comfortable and improving the postoperative recovery experience. It's a part of the overall pain management strategy for the surgery, potentially leading to better pain control and a smoother recovery process for the patient.
Who can participate?
Patients getting laparoscopic cholecystectomy
What does the study involve?
Patients were split into two groups: one receiving general anesthesia plus regular pain control, and the other receiving both of those plus an erector spinae block.
What are the possible benefits and risks of participating?
The potential advantages include better pain relief, while the risks involve the use of ultrasound to guide the block.
Where is the study run from?
Universidad del Sinu (Colombia)
When is the study starting and how long is it expected to run for?
May 2021 to February 2023
Who is funding the study?
Universidad del Sinu (Colombia)
Who is the main contact?
Mauro Causil, jjmoralesb@unal.edu.co
Contact information
Principal investigator
CALLE 38
52 249 LOS ALPES
Sincelejo
70001
Colombia
| Phone | +57 3188762847 |
|---|---|
| jjmoralesb@unal.edu.co |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective interventional randomized clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Bilateral erector spinae block for postoperative analgesia in laparoscopic cholecystectomy: A randomized clinical trial |
| Study objectives | ESPB improves postoperative analgesia and reduces opioid consumption |
| Ethics approval(s) |
Approved 08/01/2021, Clinica La Concepcion Ethics Comittee (CALLE 38 52 249 LOS ALPES, Sincelejo, 700001, Colombia; (+57) 5 2749180; info@laconcepcion.org), ref: 08012021 |
| Health condition(s) or problem(s) studied | Improvement of analgesia in patients undergoing laparoscopic cholecystectomy |
| Intervention | There were 2 study arms: one was general anaesthesia + standard analgesia and the other arm was general anaesthesia + standard analgesia + bilateral US-guided erector spinae block.Follow up was 48 hrs after surgery to record pain scores. The randomization process was done using Epi Dat 4.2. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain measured using a 0 (least)-10 (worst) pain score 1, 6, 12, 24 and 48 hr after surgery |
| Key secondary outcome measure(s) |
Requirement of opioid (Yes or No) 1 hour after surgery |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 68 |
| Total final enrolment | 68 |
| Key inclusion criteria | 1. More than 18 years old 2. ASA I,II 3. Undergoing laparoscopic cholecystectomy |
| Key exclusion criteria | 1. IMC >30 2. Open cholecystectomy 3. Allergy to local anesthetics 4. Recent opioid use |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 28/02/2023 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Sincelejo
700001
Colombia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and or analyses during the current study will be available upon request from jjmoralesb@unal.edu.co |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/09/2023: Trial's existence confirmed by Clinica La Concepcion Ethics Comittee.
