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Table 1 Study visits of the PRE-EASE trial

From: Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial

 

Study period

Enrollment

Allocation

Post-allocation

Time points

Preoperative

0 day (d)

Surgery

2 h

4 h

8 h

1 d

2d

3d

1 week (w)

Discharged

2w

4w

6w

3 months (m)

6 m

Enrollment

Eligibility screening

X

               

Informed consent

X

               

Random allocation

 

X

              

Interventions

Betamethasone plus ropivacaine

 

X

              

Ropivacaine

 

X

              

Assessments

Baseline data

X

X

X

             

Intraoperative data

  

X

             

Cumulative butorphanol consumption

    

X

X

X

X

        

Patients with no butorphanol

       

X

        

Total PCA button press count

       

X

        

Time of first analgesia demand

    

X

X

X

X

        

VASM

   

X

X

X

X

X

X

X

 

X

X

X

X

X

VASR

   

X

X

X

X

X

X

X

 

X

X

X

X

X

PSS

   

X

X

X

X

X

X

X

 

X

X

X

X

X

PONV

   

X

X

X

X

X

        

RSS

   

X

X

X

X

X

        

WHOQOL-BREF

X

              

X

ODI

X

           

X

X

X

X

POSAS

               

X

AEs

                

Nausea

   

X

X

X

X

         

Vomiting

   

X

X

X

X

         

Gastritis

   

X

X

X

X

         

GI bleeding

   

X

X

X

X

         

Delayed wound healing

   

X

X

X

X