Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy

NCT04493463 | Completed Phase 4 DMC

• 1 other identifier: KY 2019-112-02-2
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Laminoplasty and laminectomy are useful surgical procedures for the management of various conditions pertaining the spinal cord such as myelopathy, radiculopathy, neoplasm, stenosis, disc herniation, hematoma, abscess, traumatic injuries, etc. Both are generally effective procedures that decompress the spinal cord by expanding the space available for the spinal cord. Both procedures provide good neural decompression and functional improvement after surgery, thereby preventing catastrophic cord injury. However, patients undergoing these procedures experience severe pain in the postoperative period; this may lead to the increase in postoperative morbidity and complications. Suboptimal analgesic therapy causes discomfort to the patient and could increase the incidence of postoperative complications, prolong hospital stay and increase health expenses. The extensive exposure to multiple levels in spine surgeries lead to postoperative pain caused by muscular dissection and requires adequate pain relief to hasten rehabilitation, so that the incidence of chronic pain is significantly decreased. This pain is usually treated with intramuscular, epidural or IV-PCA (Intravenous- Patient Controlled Analgesia) opioids. Several oral analgesics, intermittent intravenous and intramuscular injections and PCA with several systemic side effects, have long been used for the control of postoperative pain. In 1953, Lewis et al. established that local infiltration is a reliable pain relief technique for postoperative pain, with the advantages of safety, simplicity and low cost. The intraoperative injection of 40 mg of methylprednisolone via the intra-buccal approach into the masseter muscle has found to have significantly reduced swelling, trismus and postoperative pain associated with the surgical extraction of impacted lower third molars. A single, preoperative dose of Methylprednisolone 125 mg IV before Total Knee Arthroplasty led to improvement of postoperative analgesia and immediate recovery, when combined with an extensive, multimodal oral and local infiltration analgesic regime. Preemptive administration of bupivacaine or bupivacaine plus methylprednisolone to the paravertebral muscles in patients undergoing lumbar discectomy has been proved to provide effective analgesia in the early postoperative period, when compared to patients who received no local anesthetic or steroid. The infiltration of levobupivacaine and bupivacaine plus methylprednisolone in single distance-single site, lumbar disc surgery established that postoperative analgesic requirement was significantly lower and the first analgesia demand time was also significantly later in the local anesthesia plus methylprednisolone group, compared to the control group. A randomized controlled trial of a larger scale, with a longer follow-up period, could provide a more significant data. Therefore this study has been designed as a prospective, randomized, open-label, blinded endpoint (PROBE) study with a 1 month follow-up period, to compare the efficacy of methylprednisolone plus ropivacaine versus ropivacaine alone, administered before wound closure, for providing analgesia after laminoplasty and laminectomy.

Conditions

Postoperative Pain; Neurosurgery

Keywords

Postoperative Pain; Methylprednisolone; Ropivacaine; Local Infiltration; Laminoplasty; Laminectomy

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the cumulative sufentanil dose during the 48 hours after surgery via the PCA device.

  All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.

  Within 48 hours after the surgery

Secondary Outcomes (9)

• Visual Analogue Score

  2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks and 4 weeks after surgery

• Cumulative sufentanil dose for four separate periods

  0-4, 4-8, 8-24, and 24-48 hours

• First analgesia demand on the PCA device

  Within 48 hours postoperatively

• Patient Satisfaction Score

  At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks and 4 weeks postoperatively

• Postoperative Nausea and Vomiting

  2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery

Study Arms (2)

methylprednisolone + ropivacaine + saline

EXPERIMENTAL

The local infiltration solution in the methylprednisolone plus ropivacaine with saline group (treatment group) will consist of 1 ml of 40 mg methylprednisolone plus 15ml of 1% ropivacaine and 14 ml saline.

Drug: Methylprednisolone 40 mg + Ropivacaine + Saline

ropivacaine + saline

ACTIVE COMPARATOR

The local infiltration solution in the ropivacaine plus saline group (control group) will consist of 15 ml of 1% ropivacaine and 15ml saline.

Drug: Ropivacaine + Saline

Interventions

Methylprednisolone 40 mg + Ropivacaine + Saline DRUG

To infiltrate the study solution, the surgeon will inject the incision site with a 10 cm long, 22-gauge needle before the closing of the incision site. A standard volume of 10 ml in each level will be injected, based on the study by Milligan et al., with a total of 5ml study solution injected laterally into the erector spinae muscle and 5 ml subcutaneously along both margins of the incision. This standardization will be on the basis of the number of levels to be treated, and will be consistent in each patient. The depth of penetration will include the subcutaneous tissues, paravertebral muscles, along with the deep muscles surrounding the spinous process, lamina, transverse process and facet joints; the epidural space and intrathecal space will be spared. The local infiltration solution in the treatment group will consist of a total of 30 ml study solution, containing 1 ml of 40 mg methylprednisolone plus 15ml of 1% ropivacaine and 14 ml saline.

methylprednisolone + ropivacaine + saline

Ropivacaine + Saline DRUG

To infiltrate the study solution, the surgeon will inject the incision site with a 10 cm long, 22-gauge needle before the closing of the incision site. A standard volume of 10 ml in each level will be injected, based on the study by Milligan et al., with a total of 5ml study solution injected laterally into the erector spinae muscle and 5 ml subcutaneously along both margins of the incision. This standardization will be on the basis of the number of levels to be treated, and will be consistent in each patient. The depth of penetration will include the subcutaneous tissues, paravertebral muscles, along with the deep muscles surrounding the spinous process, lamina, transverse process and facet joints; the epidural space and intrathecal space will be spared. The local infiltration solution in the control group will consist of a total of 30 ml study solution, containing 15 ml of 1% ropivacaine and 15ml saline.

ropivacaine + saline

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for laminoplasty or laminectomy under general anesthesia
• American Society of Anesthesiologists (ASA) classification I or II
• Age 18 to 64 years

You may not qualify if:

• Patient refusal
• Inability to give written informed consent
• Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS)
• Previous history of spinal surgery
• Allergy to opioids, methylprednisolone or ropivacaine
• Peri-incisional infection
• History of stroke or a major neurological deficit
• Trauma, deformity
• Psychological problems
• Extreme body mass index (BMI) (\< 15 or \> 35)
• History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects
• Patients using systemic steroids
• Pregnant or breastfeeding;
• Preoperative Glasgow Coma Scale \< 15
• Participants who have received radiation therapy or chemotherapy preoperatively, or a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (16)

• Yoon ST, Hashimoto RE, Raich A, Shaffrey CI, Rhee JM, Riew KD. Outcomes after laminoplasty compared with laminectomy and fusion in patients with cervical myelopathy: a systematic review. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S183-94. doi: 10.1097/BRS.0b013e3182a7eb7c.

  PMID: 23963000 BACKGROUND

• Hardman J, Graf O, Kouloumberis PE, Gao WH, Chan M, Roitberg BZ. Clinical and functional outcomes of laminoplasty and laminectomy. Neurol Res. 2010 May;32(4):416-20. doi: 10.1179/174313209X459084. Epub 2009 Jul 8.

  PMID: 19589202 BACKGROUND

• Joshi GP, McCarroll SM, O'Rourke K. Postoperative analgesia after lumbar laminectomy: epidural fentanyl infusion versus patient-controlled intravenous morphine. Anesth Analg. 1995 Mar;80(3):511-4. doi: 10.1097/00000539-199503000-00013.

  PMID: 7864416 BACKGROUND

• Kundra P, Gurnani A, Bhattacharya A. Preemptive epidural morphine for postoperative pain relief after lumbar laminectomy. Anesth Analg. 1997 Jul;85(1):135-8. doi: 10.1097/00000539-199707000-00024.

  PMID: 9212136 BACKGROUND

• Mesfin A, Park MS, Piyaskulkaew C, Chuntarapas T, Song KS, Kim HJ, Riew KD. Neck Pain following Laminoplasty. Global Spine J. 2015 Feb;5(1):17-22. doi: 10.1055/s-0034-1394297. Epub 2014 Oct 25.

  PMID: 25650126 BACKGROUND

• Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.

  PMID: 14576554 BACKGROUND

• Cherian MN, Mathews MP, Chandy MJ. Local wound infiltration with bupivacaine in lumbar laminectomy. Surg Neurol. 1997 Feb;47(2):120-2; discussion 122-3. doi: 10.1016/s0090-3019(96)00255-8.

  PMID: 9040811 BACKGROUND

• LEWIS DL, THOMPSON WA. Reduction of post-operative pain. Br Med J. 1953 May 2;1(4817):973-4. doi: 10.1136/bmj.1.4817.973. No abstract available.

  PMID: 13032582 BACKGROUND

• Gurbet A, Bekar A, Bilgin H, Ozdemir N, Kuytu T. Preemptive wound infiltration in lumbar laminectomy for postoperative pain: comparison of bupivacaine and levobupivacaine. Turk Neurosurg. 2014;24(1):48-53. doi: 10.5137/1019-5149.JTN.8431-13.0.

  PMID: 24535791 BACKGROUND

• Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M. Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008 Sep;17(9):1237-41. doi: 10.1007/s00586-008-0676-z. Epub 2008 Apr 19.

  PMID: 18425538 BACKGROUND

• Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. doi: 10.1016/s0278-2391(99)90486-x.

  PMID: 10513866 BACKGROUND

• Vegas-Bustamante E, Mico-Llorens J, Gargallo-Albiol J, Satorres-Nieto M, Berini-Aytes L, Gay-Escoda C. Efficacy of methylprednisolone injected into the masseter muscle following the surgical extraction of impacted lower third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):260-3. doi: 10.1016/j.ijom.2007.07.018. Epub 2008 Mar 4.

  PMID: 18296027 BACKGROUND

• Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.

  PMID: 21131371 BACKGROUND

• Ersayli DT, Gurbet A, Bekar A, Uckunkaya N, Bilgin H. Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2221-6. doi: 10.1097/01.brs.0000232801.19965.a0.

  PMID: 16946657 BACKGROUND

• Milligan KR, Macafee AL, Fogarty DJ, Wallace RG, Ramsey P. Intraoperative bupivacaine diminishes pain after lumbar discectomy. A randomised double-blind study. J Bone Joint Surg Br. 1993 Sep;75(5):769-71. doi: 10.1302/0301-620X.75B5.8376436.

  PMID: 8376436 BACKGROUND

• Mobbs RJ, Li J, Sivabalan P, Raley D, Rao PJ. Outcomes after decompressive laminectomy for lumbar spinal stenosis: comparison between minimally invasive unilateral laminectomy for bilateral decompression and open laminectomy: clinical article. J Neurosurg Spine. 2014 Aug;21(2):179-86. doi: 10.3171/2014.4.SPINE13420. Epub 2014 May 30.

  PMID: 24878273 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methylprednisolone; Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 30, 2020
• Study Start: July 31, 2020
• Primary Completion: April 6, 2021
• Study Completion: May 6, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)