Comparing pain relief methods for digestive surgery patients: intravenous lidocaine versus an abdominal block injection
| ISRCTN | ISRCTN18079505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18079505 |
- Submission date
- 05/01/2025
- Registration date
- 07/02/2025
- Last edited
- 16/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Most abdominal surgeries require various incisions, including midline cuts. Pain management should be safe, and effective, and not limit movement. Local anesthetics like intravenous lidocaine (IVL) or lateral transabdominal plane (TAP) block can reduce opioid use. This study compares the effects of IVL and lateral TAP block on NRS scores and fentanyl rescue analgesia use in digestive surgery patients with midline incisions.
Who can participate?
Adult digestive surgery patients with midline incisions
What does the study involve?
In this study, participants with be randomly assigned into two groups: one receiving IVL and the other receiving lateral TAP block. The level of pain will be assessed by a numeric rating scale at baseline, 6h, 12h, 18h, and 24h , as well as whether rescue analgesia is required to be administered if NRS ≥ 4.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Adam Malik Hospital, Pirnagdi General Hospital, Haji Hospital
When is the study starting and how long is it expected to run for?
September 2024 to January 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr. Andriamuri Primaputra Lubis, andriamuri@usu.ac.id
Contact information
Public, Scientific
Tasbih Block I No 66 Lk Tanjung Sari Kecamatan Medan Selayang
Medan
20131
Indonesia
| Phone | +62 08126078194 |
|---|---|
| andriamuri@usu.ac.id |
Principal Investigator
Jl. Ampera II, Sei Sikambing C-II, Medan Helvetia, 20122
Medan
20122
Indonesia
| Phone | +6282249356633 |
|---|---|
| dr.prasetyotrinugroho@gmail.com |
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of the effectiveness of intravenous lidocaine (IVL) and lateral trans abdominal plane (TAP) block on the numeric rating scale (NRS) in digestive surgery patients with midline incision |
| Study hypothesis | The use of the lateral TAP Block is more effective in reducing NRS scores and the need for rescue analgesia compared to the use of IVL |
| Ethics approval(s) |
Approved 06/09/2024, Health Research Ethics Committee of Universitas Sumatera Utara (dr. T. Mansur No. 66 Lt II RS. Prof. dr. Chairuddin P. Lubis, Kampus USU, Medan, 20155, Indonesia; +62-61-8211045; komiteetik@usu.ac.id), ref: 1122/KEPK/USU/2024 |
| Condition | Digestive surgery patients with midline incisions |
| Intervention | This study is a randomized single-blind controlled clinical trial, where the participants or research subjects are unaware of the group they belong to and the researchers are aware of this information. The study includes both a control group and an intervention group to compare the effects of Intravenous Lidocaine (IVL) and Lateral Trans Abdominal Plane (TAP) Block on the NRS (Numeric Rating Scale) scores in patients following digestive surgery with a midline incision. The research subjects were selected using a consecutive sampling technique until the required sample size was reached. Data collection was conducted from March to August 2024. Randomization was carried out by volunteers using computer-generated randomization through the website www.randomizer.org. The participants were divided into two groups: Group A (Intravenous Lidocaine Group) and Group B (Lateral Trans Abdominal Plane (TAP) Block Group). Patients in Group A (Intravenous Lidocaine Group) are administered a lidocaine loading dose of 1 mg/kg, followed by a maintenance dose of 1.5 mg/kg/hour after induction, continuing for 1 hour postoperatively. In Group B (Lateral Trans Abdominal Plane (TAP) Block Group), 20 cc of 0.25% ropivacaine is administered after the surgery, with ultrasound guidance used to perform the block. The ultrasound probe is placed on each lateral abdominal wall at the mid-axillary line, between the lower costal margin and the iliac crest, with a total of 40 cc of 0.25% ropivacaine being administered. The subjects were followed up at several time points (6 hours, 12 hours, 18 hours, and 24 hours post-surgery) to assess the Numeric Rating Scale (NRS) and the administration of rescue analgesics, with a total follow-up duration of 24 hours in both arms. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lidocaine |
| Primary outcome measure | Pain is measured using a Numeric Rating Scale (NRS) at baseline, 6h, 12 h, 18 h, and 24 h |
| Secondary outcome measures | The need for rescued analgetic measured using an NRS ≥ 4 at 6, 12, 18, and 24 h |
| Overall study start date | 01/09/2024 |
| Overall study end date | 10/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Male |
| Target number of participants | 48 |
| Total final enrolment | 48 |
| Participant inclusion criteria | 1. Willing to participate in the study 2. Patients aged 18-65 years 3. ASA I to III 4. Undergoing digestive surgery with a midline incision, with the highest incision level corresponding to dermatomes T6-T10 |
| Participant exclusion criteria | 1. Contraindications to nerve block such as coagulation dysfunction or infection at the puncture site, history of allergy to local anesthetics 2. Cardiac arrhythmia prior to surgery 3. Chronic pain (persistent pain lasting more than 6 months) 4. Long-term use of opioid analgesics or corticosteroids 5. Pregnancy 6. History of drug abuse or mental illness, or communication disorders 7. Neurological deficits |
| Recruitment start date | 05/09/2024 |
| Recruitment end date | 30/01/2025 |
Locations
Countries of recruitment
- Indonesia
Study participating centres
Medan
20136
Indonesia
Medan
20371
Indonesia
Medan
20234
Indonesia
Sponsor information
University/education
Jalan Dr. T. Mansur No.9, Padang Bulan, Kec. Medan Baru, Kota Medan, Sumatera Utara
Medan
20222
Indonesia
| Phone | +62 061-8210555 |
|---|---|
| dean.med@usu.ac.id | |
| Website | https://usu.ac.id |
"ROR" |
https://ror.org/01kknrc90 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sets generated during and /or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
13/01/2025: Study's existence confirmed by the Health Research Ethics Committee of Universitas Sumatera Utara.
