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

PHASE4CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

July 31, 2020

Primary Completion Date

April 6, 2021

Study Completion Date

May 6, 2021

Conditions
Postoperative PainNeurosurgery
Interventions
DRUG

Methylprednisolone 40 mg + Ropivacaine + Saline

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.

DRUG

Ropivacaine + Saline

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.

Trial Locations (1)

100070

Beijing Tiantan Hospital, Beijing

All Listed Sponsors
lead

Beijing Tiantan Hospital

OTHER

NCT04493463 - Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy | Biotech Hunter | Biotech Hunter