SpondylolisthesisPhase 4RCT-ESPBNCT05345249
Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery
A Phase 4 study testing Ropivacaine Hydrochloride Injection and Sodium chloride in people with Spondylolisthesis and Lumbar Disc Herniation, run by Ilse van de Wijgert at 1 site in Netherlands.
Trial summary
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylolisthesis, Lumbar Disc Herniation, Lumbar Spinal Stenosis
- What is being tested?
- Ropivacaine Hydrochloride Injection and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2022to 19 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach;
- 1-4 fusion level spine surgery;
- Written informed consent.
Who cannot join
- A Body Mass Index (BMI) > 40 kg/m²;
- ASA physical health classification > 3;
- Patients who will undergo spine surgery involving less than 2 or more than 4 levels of fusion, scoliosis surgery*;
- Patients who will undergo circumferent spine surgery;
- Patients with an active, local infection or systemic infection;
- Patients with an allergy to one or more medications used in the study;
Show all 13Show fewer
- Patients with any contraindication to a regional anesthetic technique;
- Kidney- or liver failure inhibiting the systemic use of paracetamol and/or NSAIDs;
- Acute surgeries;
- Patients with a history of drugs or alcohol abuse;
- Pregnancy;
- Cognitive impairment;
- Inability to speak or understand the Dutch language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block for Reduction of Early Postoperative Pain Scores and Opioid Use in Lumbar Spinal Fusion Surgery, a Prospective Double-blinded Randomized Placebo-controlled Trial
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. The literature is not yet conclusive about the effectiveness of this technique on reducing postoperative pain intensity.
Objective: The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain intensity after lumbar spinal fusion surgery compared to placebo.
Read more
Study design: The study is designed as a prospective mono-centre, randomized, double-blinded, placebo-controlled trial.
Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion surgery involving one to four fusion levels.
Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo at the end of surgery.
Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.
Read the detailed description
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use. Despite multimodal pain treatment, time to first rescue treatment with opioids is often short and necessary on the Post Anesthesia Care Unit (PACU). Latest scientific insights show most pain interventions produce mild analgesic effects, and advise a multimodal regimen based upon systemic analgesics consisting of at least gabapentoids, ketamine and opioids. Therefore, in our clinic (Sint Maartenskliniek, Nijmegen, the Netherlands), multimodal analgesia in spine surgery is now gold standard, with opioids as first choice postoperative rescue treatment. However, despite multimodal treatment, patients who underwent lumbar spine surgery still develop severe postoperative pain.
A different possible measure to lower the risk of postoperative pain is locoregional anesthesia. The Sint Maartenskliniek has a long history of applying locoregional anesthesia in orthopedic surgery. Locoregional anesthesia provides effective analgesia without systemic side-effects like drowsiness or nausea, thereby reducing perioperative systemic drug use and possibly reducing the risk of persistent postsurgical pain. A novel locoregional anesthetic technique is the erector spinae plane block (ESPB). Good quality evidence exists for the effectiveness of this technique in breast cancer surgery and video assisted thoracoscopy (VATS). Although ESPB seems a promising analgesic technique for lumbar spine surgery patients not responding to the multimodal pain treatment regimen, sufficient high quality evidence is lacking. A recent systematic review summarized the evidence of ESPB for lumbar spine surgery, including two randomized clinical trials (RCT), showing beginning evidence of reduced postoperative opioid consumption and decreased pain scores. However, these trials contained a small sample size, were not blinded or lacked a comparator. Furthermore, little information on postoperative hospital stay is provided. This results in ESPB not being widely accepted in lumbar spine surgery. The larger, double-blinded, placebo-controlled methodology in this proposed trial aims to contribute to the scientific evidence for the effectiveness of EPSB in a multimodal analgesia management setting.
Objective: The primary objective of the study is to evaluate the analgesic effect of ESPB on early postoperative pain after lumbar spinal fusion surgery. Therefore the pain intensity in the postoperative care unit upon emergence, using the Numeric Rating Scale (NRS) for pain, will be the primary outcome parameter of this study. The null hypothesis states there is no difference in effectiveness of the ESPB compared to placebo on early postoperative pain intensity measured with NRS in patients that underwent lumbar spinal fusion surgery. This hypothesis will be tested two-sided, with α = 0.05.
Study design: This study is designed as a prospective, mono-center, double-blinded, randomized, placebo controlled trial. The study will be performed at the Sint Maartenskliniek, Nijmegen, the Netherlands. The study will be performed in accordance with the ICH E6(R1) Good Clinical Practice (GCP) guidelines. The duration of the study will be determined according to the progress of inclusion. Patients scheduled for elective lumbar spinal fusion surgery will be studied. Subject of investigation is the locoregional anesthetic technique ESPB. Subjects will be randomized to receive either ESPB with a long-acting local anesthetic or normal saline (placebo).
The staff involved (doctors, nurses, OR-personal), as well as the research team and the patient will be blinded for treatment allocation. The study period includes in-hospital time after surgery and follow-up 30 days after surgery. Placement of the ESPB will be performed according to the study protocol, at the end of surgery, after wound closure. The placement of the ESPB is performed according to daily clinical practice as described by Forero et al. Postoperative treatment of patients will be according to standard hospital protocol for lumbar spinal fusion surgery.
Study population: 76 patients undergoing elective lumbar spinal fusion surgery involving one to four fusion levels will be recruited.
Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.
- Conditions
- Spondylolisthesis, Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Disc Disease, Lumbar Spondylolisthesis, Lumbar Spondylosis
- Being tested
- Ropivacaine Hydrochloride Injection, Sodium chloride
- Keywords
- Erector spinae block, Lumbar interbody fusion, Regional anesthesia, Postoperative pain
- Medical subject headings
- Spondylolisthesis, Intervertebral Disc Displacement, Spinal Stenosis, Intervertebral disc disease, Spondylosis, Spinal Diseases, Radiculopathy, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine Hydrochloride InjectionDrug
Also called SMPC h104944, Ropivacaine HCl
Investigating the effectiveness of erector spinae plane block with ropivacaine for lumbar spinal fusion surgery versus placebo.
Sodium chlorideDrug
Also called SMPC h55227, NaCl 0.9%
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| ESPB with ropivacaine | Experimental | Patients in the experimental group will receive locoregional analgesia via ESPB with injectate consisting of ropivacaine 0.375 mg/mL with no additives, two times 30mL bilaterally at the transverse processs of the T12-vertebra (total dose of 225 mg). Receives: Drug: Ropivacaine Hydrochloride Injection |
| ESPB with placebo | Placebo comparator | Patients in the placebo group will receive an injection performed as the procedure of ESPB with injectate consisting of sodiumchloride 0.9% with no additives, two times 30mL bilaterally at the transverse processs of the T12-vertebra. Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity one hour after arrival at post-anesthesia care unit
Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain) as asked by PACU-nurse
Measured: 1 hour after arrival at PACU
Secondary outcomes (10)
Acceptability of pain
Yes/no
Measured: 1 hour after arrival at PACU
Opioid use
total morphine equivalent dose as extracted from the electronic medical file and PCIA pump
Measured: 0-12 hours, 12-24 hours after surgery
Presence of opioid side effects
Nausea, vomiting and use of anti-emetics as documented in electronic medical file
Measured: 12 hours, 24 hours after surgery
Time to first opioid use/request
defined as minutes
Measured: 12 hours after surgery
Time to first mobilization
defined as hours
Measured: 72 hours after surgery
Length of hospital stay
defined as days
Measured: up to 30 days after surgery
Pain intensity
Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain)
Measured: on postoperative admission days, 30 days
Opioid use
Do you use opioids yes/no
Measured: 30 days after surgery
Quality of recovery
Quality of Recovery-15 questionnaire (Dutch version). Score 0-150 (0 = worst recovery, 150 = perfect recovery)
Measured: Postoperative day 1 and 3
Adverse events
(Serious) adverse events during study period
Measured: 0-30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jun 2022
- Primary completion19 Dec 2023
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients scheduled for elective lumbar spinal fusion surgery will be studied. Subject of investigation is the locoregional anesthetic technique ESPB. Subjects will be randomized to receive either ESPB with a long-acting local anesthetic or normal saline (placebo). The staff involved (doctors, nurses, OR-personal), as well as the research team and the patient will be blinded for treatment allocation. The study period includes in-hospital time after surgery and follow-up 30 days after surgery. Placement of the ESPB will be performed according to the study protocol, at the end of surgery, after wound closure. The placement of the ESPB is performed according to daily clinical practice as described by Forero et al. Postoperative treatment of patients will be according to standard hospital protocol for lumbar spinal fusion surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilse van de Wijgert
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor-investigator, Ilse van de Wijgert, Sint Maartenskliniek
- Investigators
- M.G.E. Fenten, MSc, PhD, MD, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345249
- Sponsor's protocol ID
- 0984
- Other IDs
- 2021-003679-32, NL9640
- Acronym
- RCT-ESPB
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: DANS EASY will be data repository for open access.
Publications
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233Alboog A, Bae S, Chui J. Anesthetic management of complex spine surgery in adult patients: a review based on outcome evidence. Curr Opin Anaesthesiol. 2019 Oct;32(5):600-608. doi: 10.1097/ACO.0000000000000765.
PubMed 31461735Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2.
PubMed 32502778Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.
PubMed 32669870Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
PubMed 30853517Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
PubMed 31033625Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016van de Wijgert IH, Fenten MGE, Rood A, van Boekel RLM, van Hooff ML, Vissers KCP. Erector Spinae Plane Block in Multimodal Analgesia After Lumbar Spinal Fusion Surgery: A Blinded Randomized Placebo-Controlled Trial. Anesth Analg. 2026 Mar 1;142(3):551-560. doi: 10.1213/ANE.0000000000007611. Epub 2025 Jul 2.
PubMed 40601485
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Reduction of Early Postoperative Pain Scores and Opioid Use in Lumbar Spinal Fusion Surgery, a Prospective Double-blinded Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05345249
- Acronym / sponsor ID
- RCT-ESPB / 0984
- Conditions
- Spondylolisthesis, Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Disc Disease, Lumbar Spondylolisthesis, Lumbar Spondylosis
- Keywords
- Erector spinae block, Lumbar interbody fusion, Regional anesthesia, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ilse van de WijgertUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. The literature is not yet conclusive about the effectiveness of this technique on reducing postoperative pain intensity.
Objective: The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain intensity after lumbar spinal fusion surgery compared to placebo.
Study design: The study is designed as a prospective mono-centre, randomized, double-blinded, placebo-controlled trial.
Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion surgery involving one to four fusion levels.
Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo at the end of surgery.
Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.
Detailed description
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use. Despite multimodal pain treatment, time to first rescue treatment with opioids is often short and necessary on the Post Anesthesia Care Unit (PACU). Latest scientific insights show most pain interventions produce mild analgesic effects, and advise a multimodal regimen based upon systemic analgesics consisting of at least gabapentoids, ketamine and opioids. Therefore, in our clinic (Sint Maartenskliniek, Nijmegen, the Netherlands), multimodal analgesia in spine surgery is now gold standard, with opioids as first choice postoperative rescue treatment. However, despite multimodal treatment, patients who underwent lumbar spine surgery still develop severe postoperative pain.
A different possible measure to lower the risk of postoperative pain is locoregional anesthesia. The Sint Maartenskliniek has a long history of applying locoregional anesthesia in orthopedic surgery. Locoregional anesthesia provides effective analgesia without systemic side-effects like drowsiness or nausea, thereby reducing perioperative systemic drug use and possibly reducing the risk of persistent postsurgical pain. A novel locoregional anesthetic technique is the erector spinae plane block (ESPB). Good quality evidence exists for the effectiveness of this technique in breast cancer surgery and video assisted thoracoscopy (VATS). Although ESPB seems a promising analgesic technique for lumbar spine surgery patients not responding to the multimodal pain treatment regimen, sufficient high quality evidence is lacking. A recent systematic review summarized the evidence of ESPB for lumbar spine surgery, including two randomized clinical trials (RCT), showing beginning evidence of reduced postoperative opioid consumption and decreased pain scores. However, these trials contained a small sample size, were not blinded or lacked a comparator. Furthermore, little information on postoperative hospital stay is provided. This results in ESPB not being widely accepted in lumbar spine surgery. The larger, double-blinded, placebo-controlled methodology in this proposed trial aims to contribute to the scientific evidence for the effectiveness of EPSB in a multimodal analgesia management setting.
Objective: The primary objective of the study is to evaluate the analgesic effect of ESPB on early postoperative pain after lumbar spinal fusion surgery. Therefore the pain intensity in the postoperative care unit upon emergence, using the Numeric Rating Scale (NRS) for pain, will be the primary outcome parameter of this study. The null hypothesis states there is no difference in effectiveness of the ESPB compared to placebo on early postoperative pain intensity measured with NRS in patients that underwent lumbar spinal fusion surgery. This hypothesis will be tested two-sided, with α = 0.05.
Study design: This study is designed as a prospective, mono-center, double-blinded, randomized, placebo controlled trial. The study will be performed at the Sint Maartenskliniek, Nijmegen, the Netherlands. The study will be performed in accordance with the ICH E6(R1) Good Clinical Practice (GCP) guidelines. The duration of the study will be determined according to the progress of inclusion. Patients scheduled for elective lumbar spinal fusion surgery will be studied. Subject of investigation is the locoregional anesthetic technique ESPB. Subjects will be randomized to receive either ESPB with a long-acting local anesthetic or normal saline (placebo).
The staff involved (doctors, nurses, OR-personal), as well as the research team and the patient will be blinded for treatment allocation. The study period includes in-hospital time after surgery and follow-up 30 days after surgery. Placement of the ESPB will be performed according to the study protocol, at the end of surgery, after wound closure. The placement of the ESPB is performed according to daily clinical practice as described by Forero et al. Postoperative treatment of patients will be according to standard hospital protocol for lumbar spinal fusion surgery.
Study population: 76 patients undergoing elective lumbar spinal fusion surgery involving one to four fusion levels will be recruited.
Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients scheduled for elective lumbar spinal fusion surgery will be studied. Subject of investigation is the locoregional anesthetic technique ESPB. Subjects will be randomized to receive either ESPB with a long-acting local anesthetic or normal saline (placebo). The staff involved (doctors, nurses, OR-personal), as well as the research team and the patient will be blinded for treatment allocation. The study period includes in-hospital time after surgery and follow-up 30 days after surgery. Placement of the ESPB will be performed according to the study protocol, at the end of surgery, after wound closure. The placement of the ESPB is performed according to daily clinical practice as described by Forero et al. Postoperative treatment of patients will be according to standard hospital protocol for lumbar spinal fusion surgery.
| Arm | Type | Receives |
|---|---|---|
| ESPB with ropivacaine | Experimental | Drug: Ropivacaine Hydrochloride InjectionPatients in the experimental group will receive locoregional analgesia via ESPB with injectate consisting of ropivacaine 0.375 mg/mL with no additives, two times 30mL bilaterally at the transverse processs of the T12-vertebra (total dose of 225 mg). |
| ESPB with placebo | Placebo comparator | Drug: Sodium chloridePatients in the placebo group will receive an injection performed as the procedure of ESPB with injectate consisting of sodiumchloride 0.9% with no additives, two times 30mL bilaterally at the transverse processs of the T12-vertebra. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach;
- 1-4 fusion level spine surgery;
- Written informed consent.
Key exclusion criteria (13 listed)
- A Body Mass Index (BMI) > 40 kg/m²;
- ASA physical health classification > 3;
- Patients who will undergo spine surgery involving less than 2 or more than 4 levels of fusion, scoliosis surgery*;
- Patients who will undergo circumferent spine surgery;
- Patients with an active, local infection or systemic infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine Hydrochloride InjectionAlso: SMPC h104944, Ropivacaine HClInvestigating the effectiveness of erector spinae plane block with ropivacaine for lumbar spinal fusion surgery versus placebo. | Drug | ESPB with ropivacaine |
| Sodium chlorideAlso: SMPC h55227, NaCl 0.9%Placebo comparator | Drug | ESPB with placebo |
Primary outcome
Pain intensity one hour after arrival at post-anesthesia care unit
Time frame: 1 hour after arrival at PACU
Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain) as asked by PACU-nurse
10 secondary outcomes
Acceptability of pain
Time frame: 1 hour after arrival at PACU
Opioid use
Time frame: 0-12 hours, 12-24 hours after surgery
Presence of opioid side effects
Time frame: 12 hours, 24 hours after surgery
Time to first opioid use/request
Time frame: 12 hours after surgery
Time to first mobilization
Time frame: 72 hours after surgery
Length of hospital stay
Time frame: up to 30 days after surgery
Pain intensity
Time frame: on postoperative admission days, 30 days
Opioid use
Time frame: 30 days after surgery
Quality of recovery
Time frame: Postoperative day 1 and 3
Adverse events
Time frame: 0-30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Background: PubMed 31461735Alboog A, Bae S, Chui J. Anesthetic management of complex spine surgery in adult patients: a review based on outcome evidence. Curr Opin Anaesthesiol. 2019 Oct;32(5):600-608. doi: 10.1097/ACO.0000000000000765.
- Background: PubMed 32502778Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2.
- Background: PubMed 32669870Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020.
- Background: PubMed 30853517Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
- Background: PubMed 31033625Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Derived from this study: PubMed 40601485van de Wijgert IH, Fenten MGE, Rood A, van Boekel RLM, van Hooff ML, Vissers KCP. Erector Spinae Plane Block in Multimodal Analgesia After Lumbar Spinal Fusion Surgery: A Blinded Randomized Placebo-Controlled Trial. Anesth Analg. 2026 Mar 1;142(3):551-560. doi: 10.1213/ANE.0000000000007611. Epub 2025 Jul 2.
- Individual participant dataSharing planned: Yes. DANS EASY will be data repository for open access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.G.E. Fenten, MSc, PhD, MD principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine Hydrochloride Injection and Sodium chloride in people with Spondylolisthesis and Lumbar Disc Herniation, run by Ilse van de Wijgert at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity one hour after arrival at post-anesthesia care unit (time frame: 1 hour after arrival at PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345249, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.