CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 116 enrolled
Drug / intervention
The Treatment group +1 moredrug
Likely dose
The Treatment group 30 mlfrom record
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Search/NCT04153396
NCT04153396Phase 4Completed

Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE)

Beijing Tiantan Hospital·interventional·Posted Nov 6, 2019·Updated Mar 14, 2023

In Brief

A Phase 4 clinical trial evaluating The Treatment group and The Control group for Pain, Postoperative and Neurosurgery. Completed, enrolled 116 participants across 1 site.

Detailed Summary

Laminoplasty and laminectomy have been used for decades for the treatment of intraspinal space occupying lesions, spinal stenosis, disc herniation, injuries, etc. After these procedures, patients often experience severe postoperative pain at the surgical site. However, current methods of pain control are mostly insufficient. At present, several pain controlling methods are available, to reduce postoperative pain after laminoplasty or laminectomy. Methods for systemic administration include: oral analgesics, intermittent intravenous, intramuscular injections, patient- controlled intravenous analgesia, etc. However, the aforementioned methods may have a lot of side effects, and are usually used after the occurrence of pain and the analgesic effects are sometimes inadequate. Topical administration options use a lower dose of drugs and therefore have less systemic side effects. Pre-emptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement, however, the analgesic effect is maintained for a relatively short period of time. It is necessary to use more cases to explore the other compatibility of drugs with longer duration of action and stronger analgesic effect. Betamethasone as the stereoisomer of dexamethasone is a long-acting corticosteroid, which has long lasting anti-inflammatory properties. Whether betamethasone combined with local anesthetic for laminoplasty or laminectomy has better short-term and long-term effects than the local anesthetic alone has not been reported yet. Therefore, a prospective, randomized, controlled, blinded-endpoint study is needed to compare the postoperative analgesic efficacy of preemptive wound infilteration of ropivacaine alone and betamethasone plus ropivacaine for laminectomy or laminoplasty.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartSep 1, 2021
Primary CompletionDec 3, 2021
Study CompletionJun 3, 2022
TodayJul 1, 2026
Enrollment to primary: 3 monthsPosted 6.7 years ago

Interventions

The Treatment groupdrug

The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 0.5ml of compound betamethasone injection(betamethasone propionate 5mg and betamethasone sodium phosphate 2mg per 1ml) added to 14.5ml of saline and 15ml of 1% ropivacaine. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.

The Control groupdrug

The local infiltration solution in the control group will consist of ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 15ml of ropivacaine added to 15 ml of saline for the Control group. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.