Comparative analysis of pain control methods after ankle fracture surgery with a peripheral nerve block
| ISRCTN | ISRCTN17431025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17431025 |
- Submission date
- 12/07/2023
- Registration date
- 13/07/2023
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study aimed to compare the effectiveness of peripheral nerve block combined with dexamethasone/epinephrine versus patient-controlled analgesia using ketorolac in patients with ankle fractures. The rationale for this study was that the analgesic effect of anesthetics could potentially be enhanced by the addition of dexamethasone or epinephrine, although the exact mechanism is still unknown.
Who can participate?
Patients aged 18–70 years who were surgically treated for ankle fractures between December 2021 and September 2022
What does the study involve?
The patients were divided into two groups: Group A received patient-controlled analgesia following lower extremity peripheral nerve block, while Group B received a combination of dexamethasone/epinephrine with the anesthetic solution during peripheral nerve block.
What are the possible benefits and risks of participating?
If a significant pain relief effect was found in this study, it would be an opportunity to relieve pain and increase satisfaction after surgery for subjects who underwent open reduction and metal fixation for ankle fractures.
This study is a prospective interventional study, but it is a drug that is commonly used postoperatively or has already secured safety to reduce postoperative pain, and there are no risk factors that deviate from general treatment for patients due to participation in this study.
Where is the study run from?
Chungnam National University Hospital (South Korea)
When is the study starting and how long is it expected to run for?
November 2021 to October 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Gisoo Lee, gslee1899@gmail.com
Contact information
Scientific
4717 Glenwood ave
La crescenta
91214
United States of America
 ORCID ID |
0000-0002-4085-5674 |
|---|---|
| Phone | +1 8186534891 |
| gs1899@cnuh.co.kr |
Study information
| Study design | Single-center randomized controlled prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Comparative analysis of pain control methods after ankle fracture surgery with a peripheral nerve block: A single center randomized controlled prospective study |
| Study objectives | We hypothesized that peripheral nerve block with dexamethasone and epinephrine is more effective than other pain control methods after conventional peripheral nerve block. This study aimed to prospectively compare peripheral nerve block combined with dexamethasone/epinephrine and patient-controlled analgesia using ketorolac after peripheral nerve block anesthesia in patients with ankle fractures. |
| Ethics approval(s) |
Approved 01/12/2021, Chungnam National University Sejong Hospital (Bodeum 7ro, 20, Sejong, 30099, Korea, South; +82 44 995 4950; cnuhirb@cnuh.co.kr), ref: CNUSH 2021-11-003 |
| Health condition(s) or problem(s) studied | Ankle fracture |
| Intervention | All patients were anesthetized using ultrasound-guided PNB with ropivacaine. Group A received PCA with ketorolac for postoperative pain management after PNB. Group B received PCA with normal saline; instead, dexamethasone and epinephrine were added to ropivacaine during PNB. The allocation sequence was concealed from the researchers and participants in sequentially numbered, opaque sealed envelopes. The envelopes were opened only for the researchers after the enrolled participants had completed all baseline assessments when it was time to perform the intervention in the operation room. A sample size of 59 patients was determined based on the following parameters: significance level (5%), statistical power (90%), sample ratio (1:1), variance (2.5), and difference between the two groups (1.5). To obtain a 1:1 ratio between groups, we included 60 cases (30 in each group). In group A, PCA was initiated approximately 10 hours after PNB induction. The treatment comprised 4 mL ketorolac (120 mg) and 100 mL normal saline. An initial bolus of 8 mL was injected, followed by an additional 96 mL slowly administered by a PCA instrument (Auto Selector; Tecnica Scientifica Service, Torino, Italy) over 48 hours. A maintenance dose of 2 mL/hour was administered, with each additional PCA bolus containing 1 mL and a lockout interval of 15 minutes. In group B, PNB was performed using an anesthetic solution of ropivacaine (Naropin®, AstraZeneca AB, Sodertalje, Sweden) combined with dexamethasone disodium phosphate 5 mg (5 mg/mL, Daewon Pharm. Co., Ltd., Seoul, Korea) and epinephrine 0.1 mg (1 mg/mL, Daihan Pharm. Co., Ltd., Seoul, Korea; epinephrine was added at a ratio of 1:200,000). The same PCA instrument was also used for all patients in group B. However, only normal saline was administered in the same way as in group A. We kept all patients unaware of which group they belonged to until the end of the study. To do so, the same PCA instrument was applied to all patients included in this study. In both groups, patients with visual analog scale (VAS) scores ≥5 received intravenous acetaminophen (Kabi paracetamol 100 mL, 1 mg/mL, Fresenius Kabi, Friedberg, Germany) for rescue analgesia. VAS scores obtained within 8 hours of intravenous acetaminophen injection were excluded from the analysis. No other pain control medications or methods were used in either group. This study was conducted while patients were hospitalized for 3 days after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain intensity (VAS score: 0, no pain; 10, worst pain imaginable) at 6, 12, 18, 24, 32, 40, 48, and 60 hours after peripheral nerve block |
| Secondary outcome measures | 1. The time at which the sensation began (analgesia time) and the time at which motor function was restored were recorded using patient records 2. After three days of administering pain control, a questionnaire was completed to assess patients' satisfaction with the pain control method (Likert scale). |
| Overall study start date | 01/11/2021 |
| Completion date | 30/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Unilateral open reduction and internal fixation for ankle fractures were performed on the patients 2. Fracture types included fractures involving the articular surface of the distal tibia and fibula, including simple fibula fractures, bimalleolar fractures, trimalleolar fractures, and pilon fractures. |
| Key exclusion criteria | 1. uncontrolled diabetes mellitus 2. peripheral vascular disease, renal or hepatic disease, or any neurologic disease 3. contraindication for regional anesthesia (coagulopathy or injection site infection). 4. Patients with body mass index <18.5 kg/m² ( World Health Organization standard) 5. Patients with suspected or nerve injuries requiring careful post-operative observation and those at risk of compartment syndrome |
| Date of first enrolment | 01/12/2021 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
sejong
30099
Korea, South
Sponsor information
Hospital/treatment centre
Bodeum 7ro, 20
sejong
30099
Korea, South
| Phone | +82 1040173308 |
|---|---|
| cnuhirb@cnuh.co.kr | |
| Website | https://www.cnush.co.kr/main/index.do |
"ROR" |
https://ror.org/04353mq94 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Gisoo Lee, gslee1899@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/07/2023 | 06/08/2024 | Yes | No |
Editorial Notes
06/08/2024: Publication reference added.
13/07/2023: Trial's existence confirmed by Chungnam National University Sejong Hospital.
