Lumbar Spinal Stenosis Clinical Trial
— RCT-ESPBOfficial 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
Verified date | April 2024 |
Source | Sint Maartenskliniek |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | January 19, 2024 |
Est. primary completion date | December 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Sint Maartenskliniek | Ubbergen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Ilse van de Wijgert | Radboud University Medical Center |
Netherlands,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Drain wound leakage | mLs of drain wound leakage, if drain is present | Postoperative day 1, 2 and 3 | |
Primary | 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 | 1 hour after arrival at PACU | |
Secondary | Acceptability of pain | Yes/no | 1 hour after arrival at PACU | |
Secondary | Opioid use | total morphine equivalent dose as extracted from the electronic medical file and PCIA pump | 0-12 hours, 12-24 hours after surgery | |
Secondary | Presence of opioid side effects | Nausea, vomiting and use of anti-emetics as documented in electronic medical file | 12 hours, 24 hours after surgery | |
Secondary | Time to first opioid use/request | defined as minutes | 12 hours after surgery | |
Secondary | Time to first mobilization | defined as hours | 72 hours after surgery | |
Secondary | Length of hospital stay | defined as days | up to 30 days after surgery | |
Secondary | Pain intensity | Numeric Rating Scale (NRS) for pain 0-10 (0 = no pain, 10 = maximum pain) | on postoperative admission days, 30 days | |
Secondary | Opioid use | Do you use opioids yes/no | 30 days after surgery | |
Secondary | Quality of recovery | Quality of Recovery-15 questionnaire (Dutch version). Score 0-150 (0 = worst recovery, 150 = perfect recovery) | Postoperative day 1 and 3 | |
Secondary | Adverse events | (Serious) adverse events during study period | 0-30 days after surgery |
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