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NCT Number: NCT04493463

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

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.

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Within 48 hours after the surgery

    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.

Secondary outcomes

  1. Visual Analogue Score

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

    Pain will be assessed by the visual analogue scale (VAS): VAS at movement and VAS at rest in which scores (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)

  2. Cumulative sufentanil dose for four separate periods

    Time frame: 0-4, 4-8, 8-24, and 24-48 hours

    The cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 hours), a total press count including both valid and invalid presses. ( a higher cumulative sufentanil dose means worse pain)

  3. First analgesia demand on the PCA device

    Time frame: Within 48 hours postoperatively

    The time from the end of the surgery to the first administration of analgesia via the PCA device ( a faster analgesia demand means worse pain)

  4. Patient Satisfaction Score

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

    Patient Satisfaction Score (PSS) used in this study comprises of points 1-4: 1- Surgery met my expectations; 2- I did not improve as much as I had hoped but I would undergo the same operation for the same results; 3- Surgery helped but I would not undergo the same operation for the same outcome; 4- I am the same or worse as compared to before surgery; ( a higher score means worse pain)

  5. Postoperative Nausea and Vomiting

    Time frame: 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery

    Postoperative Nausea and Vomiting (PONV) will be measured using an ordinal scale, with 0 - no nausea; 1 - mild nausea not requiring treatment; 2 - nausea requiring treatment; 3 - vomiting ( a higher score means worse outcome)

  6. Ramsay Sedation Scale

    Time frame: 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery

    Ramsay Sedation Scale (RSS) will be measured using a 6-point scale to assess sedation levels, with 1 indicating agitated, anxious; 2 - cooperative; 3 - only responds to commands; 4 - strong response to glabellar tapping or noisy stimulants; 5 - weak response to glabellar tapping or noisy stimulants; 6 - no response ( a higher score means worse outcome)

  7. The World Health Organization Quality of Life-BREF scores

    Time frame: 4 weeks after surgery

    The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores will be used to obtain scores for four domains related to quality of life: physical health (7 items), psychological (6 items), social relationships (3 items) and environment (8 items). It will also include two stand-alone questions on overall quality of life and satisfaction with health. Each question will be rated on a scale of 1-5 with higher scores signifying better quality of life.

  8. Oswestry Disability Index

    Time frame: Preoperatively and at 4 weeks postoperatively

    Functional disability will be assessed preoperatively and at 4 weeks after surgery using the Oswestry Disability Index (ODI). It will include 10 questions about pain and activities of daily living. Each item will have five response categories from no pain related disability (0), to the worst possible pain related disability (100) ( a higher score means worse pain)

  9. Patient Scar Assessment and the Observer Scar Assessment Scale

    Time frame: 4 weeks postoperatively

    Patient Scar Assessment and Observer Scar Assessment Scale (POSAS), comprised of subjective symptoms of pain and pruritus, such as vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion will be assessed at 1 month postoperatively; 0 represents normal skin and 10 represents worse outcome

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2020
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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