search
Back to results

Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery (RCT-ESPB)

Primary Purpose

Spondylolisthesis, Lumbar Disc Herniation, Lumbar Spinal Stenosis

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Ropivacaine Hydrochloride Injection
Sodium chloride
Sponsored by
Maaike Fenten
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylolisthesis focused on measuring Erector spinae block, Lumbar interbody fusion, Regional anesthesia, Postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years;
  • Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach;
  • 2-4 level spine fusion surgery;
  • Written informed consent.

Exclusion Criteria:

  • 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;
  • 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.

Sites / Locations

  • Sint MaartenskliniekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ESPB with ropivacaine

ESPB with placebo

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acceptability of pain
Yes/no
Opioid use
total morphine equivalent dose as extracted from the electronic medical file and PCIA pump
Presence of opioid side effects
Nausea, vomiting and use of anti-emetics as documented in electronic medical file
Time to first opioid use/request
defined as minutes
Time to first mobilization
defined as hours
Length of hospital stay
defined as days
Pain intensity
Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain)
Opioid use
Do you use opioids yes/no
Quality of recovery
Quality of Recovery-15 questionnaire (Dutch version). Score 0-150 (0 = worst recovery, 150 = perfect recovery)
Adverse events
(Serious) adverse events during study period

Full Information

First Posted
March 28, 2022
Last Updated
June 23, 2023
Sponsor
Maaike Fenten
Collaborators
Radboud University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05345249
Brief Title
Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery
Acronym
RCT-ESPB
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maaike Fenten
Collaborators
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylolisthesis, Lumbar Disc Herniation, Lumbar Spinal Stenosis, Lumbar Disc Disease, Lumbar Spondylolisthesis, Lumbar Spondylosis, Lumbar Spine Disease, Lumbar Radiculitis, Spinal Fusion, Fusion of Spine, Spondylosis Lumbosacral Region
Keywords
Erector spinae block, Lumbar interbody fusion, Regional anesthesia, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
After obtaining informed consent, the coordinating researcher creates a study case. Patients will be randomly allocated in a 1:1 ratio to either the study group (ESPB) or the control group (placebo) by the hospital's pharmacist on the day of surgery. Permuted block randomization with varying permuted block sizes will be used. This block randomization list will be created by Sealed EnvelopeTM and managed by the hospital's pharmacist. Only the hospital's pharmacist will have access to the randomization list. The staff involved (doctors, nurses, operation room personal), as well as the research team and the patient will be blinded for treatment allocation. The hospital's pharmacist prepares the medication on the morning of surgery, delivers it at the operation complex and collects empty syringes after injection in terms of drug accountability.
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESPB with ropivacaine
Arm Type
Experimental
Arm Description
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).
Arm Title
ESPB with placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hydrochloride Injection
Other Intervention Name(s)
SMPC h104944, Ropivacaine HCl
Intervention Description
Investigating the effectiveness of erector spinae plane block with ropivacaine for lumbar spinal fusion surgery versus placebo.
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Other Intervention Name(s)
SMPC h55227, NaCl 0.9%
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Pain intensity one hour after arrival at post-anesthesia care unit
Description
Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain) as asked by PACU-nurse
Time Frame
1 hour after arrival at PACU
Secondary Outcome Measure Information:
Title
Acceptability of pain
Description
Yes/no
Time Frame
1 hour after arrival at PACU
Title
Opioid use
Description
total morphine equivalent dose as extracted from the electronic medical file and PCIA pump
Time Frame
0-12 hours, 12-24 hours after surgery
Title
Presence of opioid side effects
Description
Nausea, vomiting and use of anti-emetics as documented in electronic medical file
Time Frame
12 hours, 24 hours after surgery
Title
Time to first opioid use/request
Description
defined as minutes
Time Frame
12 hours after surgery
Title
Time to first mobilization
Description
defined as hours
Time Frame
72 hours after surgery
Title
Length of hospital stay
Description
defined as days
Time Frame
up to 30 days after surgery
Title
Pain intensity
Description
Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain)
Time Frame
on postoperative admission days, 30 days
Title
Opioid use
Description
Do you use opioids yes/no
Time Frame
30 days after surgery
Title
Quality of recovery
Description
Quality of Recovery-15 questionnaire (Dutch version). Score 0-150 (0 = worst recovery, 150 = perfect recovery)
Time Frame
Postoperative day 1 and 3
Title
Adverse events
Description
(Serious) adverse events during study period
Time Frame
0-30 days after surgery
Other Pre-specified Outcome Measures:
Title
Drain wound leakage
Description
mLs of drain wound leakage, if drain is present
Time Frame
Postoperative day 1, 2 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I.H. van de Wijgert, MSc, MD
Phone
+31243272593
Email
i.vandewijgert@maartenskliniek.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M.G.E. Fenten, MSc, PhD, MD
Organizational Affiliation
Sint Maartenskliniek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint Maartenskliniek
City
Ubbergen
State/Province
Gelderland
ZIP/Postal Code
6500GM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I.H. van de Wijgert, MSc MD
Phone
0243272593
Email
i.vandewijgert@maartenskliniek.nl
First Name & Middle Initial & Last Name & Degree
M.G.E. Fenten, MD PhD
Phone
0243272941
Email
m.fenten@maartenskliniek.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
DANS EASY will be data repository for open access.
IPD Sharing Time Frame
After end of inclusion period for at least 5 years.
IPD Sharing Access Criteria
DANS EASY will be data repository for open access. FAIR Guiding Principles are followed to make data Findable, Accessible, Interoperable and Reusable. An Open Access-licence is required to consult the data.
IPD Sharing URL
https://dans.knaw.nl/en/data-services/easy/
Citations:
PubMed Identifier
23392233
Citation
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.
Results Reference
background
PubMed Identifier
31461735
Citation
Alboog 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.
Results Reference
background
PubMed Identifier
32502778
Citation
Huang 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.
Results Reference
background
PubMed Identifier
32669870
Citation
Qiu 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.
Results Reference
background
PubMed Identifier
30853517
Citation
Yayik 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.
Results Reference
background
PubMed Identifier
31033625
Citation
Singh 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.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero 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.
Results Reference
background

Learn more about this trial

Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery

We'll reach out to this number within 24 hrs