Using ultrasound to guide pain relief during minimally invasive spine surgery
| ISRCTN | ISRCTN69505916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69505916 |
- Submission date
- 31/03/2025
- Registration date
- 23/04/2025
- Last edited
- 07/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study explores whether ultrasound-guided erector spinae plane block (ESPB) can improve the surgical experience of patients undergoing PTED for lumbar disc herniation, compared to traditional local anesthesia.
Who can participate?
Adults aged 18–65 years with confirmed single-level lumbar disc herniation who have failed conservative treatment.
Participants will be excluded if they:
(1)patients with surgical contraindication; (2) multiple segments of disc herniation, vertebral infection or tumor; (3) lumbar spondylolisthesis, obvious degenerative deformities, instability, and scoliosis; (4) substantial diseases of important organs; and (5) patients who withdrew their participation.
What does the study involve?
Clinical Application of Ultrasound-guided Erector Spinae Plane Block in Percutaneous Transforaminal Endoscopic Discectomy
What are the possible benefits and risks of participating?
ESPB may provide better intraoperative comfort and stability. Risks are minimal, as both techniques are standard and widely used.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The study is being conducted at the Dehua County Hospital, Fujian Province (China)
When is the study starting and how long is it expected to run for?
May 2021 to December 2021
Who is funding the study?
Dehua County Hospital (China)
Who is the main contact?
Xiaoting Zheng, No. 32 Xunzhong Town, Dehua County, Quanzhou City, Fujian Province, China
E-mail:1540635330@qq.com
Contact information
Public, Scientific, Principal Investigator
No. 32 Xunzhong Town, Dehua County, Quanzhou City
Quanzhou
362500
China
 ORCID ID |
0000-0003-3458-1424 |
|---|---|
| Phone | +86 15377986263 |
| 1540635330@qq.com |
Study information
| Study design | Single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | A randomized controlled trial comparing ultrasound-guided erector spinae plane block versus local anesthesia for pain control and perioperative outcomes in percutaneous transforaminal endoscopic discectomy |
| Study objectives | Ultrasound-guided erector spinae plane block (ESPB) improves intraoperative comfort, hemodynamic stability, and pain control compared to local anesthesia in PTED, without compromising surgical efficacy or increasing postoperative complications. |
| Ethics approval(s) |
Approved 20/05/2021, Dehua County Hospital Medical Ethics Committee (No. 32 Xunzhong Town, Dehua County, Quanzhou City, Fujian Province 362500, Quanzhou, 362500, China; +86 595-23522460; jiang@gmail.com), ref: 2021L[001] |
| Health condition(s) or problem(s) studied | Ultrasound-guided erector spinae plane block in percutaneous transforaminal endoscopic discectomy |
| Intervention | Intervention Group (ESPB): The ultrasound-guided erector spinae plane block (ESPB) is administered once prior to surgery. No repeated dosing is involved. Control Group (LA): Local anesthesia is similarly administered once before surgery. All participants are followed for a total of 6 months post-operation, with assessments conducted at baseline (pre-operation), 3 months, and 6 months post-operation. These include measurements of pain (VAS), functional status (ODI), and clinical outcomes (modified Macnab criteria). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Intraoperative VAS scores (Visual Analog Scale) at foraminoplasty, annulus fibrosus operation, and end of surgery. 2. Measured using VAS during the procedure. |
| Secondary outcome measures | 1. Mean arterial pressure (MAP) and heart rate (HR) at four perioperative time points (T0–T3) 2. Operation time, intraoperative blood loss, length of hospital stay 3. Modified Macnab criteria at 3-month follow-up 4. Pre- and postoperative VAS and ODI scores at 3 and 6 months 5. Reoperation willingness on post-op Day 1 |
| Overall study start date | 01/05/2021 |
| Completion date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 32 Years |
| Upper age limit | 56 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Invalid conservative treatment for twelve weeks 2. Patients complaining of lower back and lower limb pain or numbness and motor weakness due to LDH 3. Symptoms associated with pre-operative MRI and CT scans 4. None of the patients had a prior history of percutaneous foraminal surgery 5. Imagological examination showing single-segmental LDH without accompanying thickening and calcification of posterior longitudinal ligament and ligamentum flavum |
| Key exclusion criteria | 1. Patients with surgical contraindication 2. Multiple segments of disc herniation, vertebral infection or tumor 3. Lumbar spondylolisthesis, obvious degenerative deformities, instability, and scoliosis 4. Substantial diseases of important organs 5. Patients who withdrew their participation |
| Date of first enrolment | 20/05/2021 |
| Date of final enrolment | 01/12/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Quanzhou
362500
China
Sponsor information
Hospital/treatment centre
No. 32 Xunzhong Town, Dehua County, Quanzhou City
Quanzhou
362500
China
| Phone | +86 595-23522460 |
|---|---|
| jiang@gmail.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 analysed during the current study are available from the corresponding author on reasonable request E-mail:1540635330@qq.com |
Editorial Notes
31/03/2025: Trial's existence confirmed by Dehua County Hospital Medical Ethics Committee.
