Effects of Methylprednisolone on Immunological Function and Postoperative Pain
Condition: Methylprednisolone; Immunological Function; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Surgical trauma is characterized by a tightly integrated sequence of neurohumoral and
      immunological processes. When this is marked, it can manifest as a clinical entity called the
      systemic inflammatory response syndrome. Previous studies reported that inflammatory milieu
      in the postoperative period can be a harmful and potentially modifiable condition that may
      affect postoperative recovery, which includes the level of pain, fatigue, dizziness, nausea
      and vomiting (PONV), muscle weakness, and sleep quality and then increases the need for
      hospitalization. The effect of postoperative inflammation-related immune suppression such as
      the T-cell exhaustion and lymphocyte anergy may render the patient vulnerable to both
      infection and the recurrence of malignancy on postoperative infection risk and malignancy
      recurrence are currently subjects of intense speculation and investigation.

      Glucocorticoids are well known for their analgesic, anti-inflammatory, immunosuppressive
      agents and antiemetic effects. Though previous studies' results on postoperative outcome have
      been positive and in favor of glucocorticoid use, with postoperative nausea and vomiting and
      pain outcome parameters most significantly improved. However, high-dose methylprednisolone
      treatment could result in decreases T-cells postoperatively. Based on these consideration,
      the aim of our study was to assess the effect of a single low-dose preoperative
      methylprednisolone (MP) 1 mg/Kg i.v. on postoperative pain and immune functions in patients
      undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.
    

Detailed description: 
      The eighty-one patients were randomly assigned either to the MP Group or the Control Group in
      a 1:1 ratio using a computer-generated randomization number sequence. The group assignment
      was sealed in sequentially numbered opaque envelopes. No stratiﬁcation or block randomization
      was made. The envelopes were opened on the morning of surgery, and the trial drug was
      prepared by a senior anaesthetist not otherwise involved in data collection. The MP group
      received a single-dose of MP, 1 mg/Kg i.v. (Solu-Medrolw; Pﬁzer, Ballerup, Denmark) and the
      Control group a single-dose of isotonic saline ( equal capacity with MP) i.v. The test
      solution was administered just 30 mins before the operation. The patients, attending
      anesthesiologists, surgeons, and data collectors were all blinded to patient group
      assignment.The primary outcomes of the levels of T lymphocyte subsets of CD3+, CD4+, and
      CD8+, and the CD4+/CD8+ ratio were measured at T0, T1, and T2. Postoperative pain scores were
      evaluated by the visual analog scale (VAS) score16, where 0 indicates painlessness, and 10
      indicates severe pain. The patients were asked to evaluate their pain at rest and during
      coughing at 2, 4, 6, and 24 hours postoperatively. Total pump press numbers of PCA and
      adverse effects during 24 hours after surgery such as hypotension, bradycardia, nausea and
      vomiting, and dizzy were recorded and treated accordingly.
    

Intervention name(s): Methylprednisolone 1 mg•kg-1; isotonic saline 1mg•kg-1
Intervention type(s): Drug; Drug
Intervention description(s): Patients in Group M received methylprednisolone 1mg•kg-1; Patients in Group C received isotonic saline 1mg•kg-1
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methylprednisolone; Postoperative pain; Immunological function