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

ABSTRACT: BACKGROUND: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. Intense immediate postoperative pain after many spinal procedures makes its control of utmost importance. Preemptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement; however, the analgesic effect is only maintained for a relatively short period of time. 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. METHODS:The PRE-EASE trial is a prospective, randomized, open-label, blinded endpoint, single-center clinical study including 116 participants scheduled for elective laminoplasty or laminectomy, with a 6?months' follow-up process. Preemptive local infiltration with betamethasone and ropivacaine (treatment group) or ropivacaine alone (control group) throughout the entire thickness of the planned incision site will be performed by the surgeon prior to making the incision. The primary outcome will be the cumulative butorphanol consumption within the first 48-h postoperative period. DISCUSSION:This study will add significant new knowledge to the effect and feasibility of preemptive local infiltration of betamethasone for postoperative pain management in laminoplasty and laminectomy. TRIAL REGISTRATION:ClinicalTrials.gov: NCT04153396. Registered on 6 November 2019.

SUBMITTER: Shrestha N

PROVIDER: S-EPMC7201781 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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

Shrestha Niti N Wu Liang L Wang Xiaodi X Jia Wenqing W Luo Fang F

Trials 20200505 1

<h4>Background</h4>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. Intense immediate postoperative pain after many spinal procedures makes its control of utmost importance. Preemptive injection of local anesthetics can significantly reduce postoperative pain during rest and movement; ho ...[more]

PMID: 32370780

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Project description:BackgroundPostoperative pain after laminoplasty and laminectomy occurs partially from local trauma of the paraspinal tissue. Finding a multimodal analgesic cocktail to enhance the duration and effect of local infiltration analgesia is crucial. Because of rapid onset and long duration of action of betamethasone, we hypothesized that, a preemptive multimodal infiltration regimen of betamethasone and ropivacaine reduces pain scores and opioid demand, and improves patient satisfaction following laminoplasty and laminectomy.Materials and methodsThis prospective, randomized, open-label, blinded endpoint study was conducted between September 1, 2021 and June 3, 2022, and included patients between the ages of 18 to 64 scheduled for elective laminoplasty or laminectomy under general anesthesia, with American Society of Anesthesiologists classification I/II. 116 patients were randomly assigned to either the BR (Betamethasone-Ropivacaine) group or the R (Ropivacaine) group in a 1:1 ratio. Each group received preemptive infiltration of a total of 10 ml study solution into each level. Every 30 ml of study solution composed of 0.5 ml of Betamethasone plus 14.5 ml of saline and 15 ml of 1% ropivacaine for the BR group, and 15 ml of 1% ropivacaine added to 15 ml of saline for the R group. Infiltration of epidural space and intrathecal space were avoided and spinous process, transverse process, facet joints and lamina were injected, along with paravertebral muscles and subcutaneous tissue. Cumulative 48 hours postoperative butorphanol consumption via PCA (Patient-controlled analgesia) was the primary outcome. Intention-to-treat (ITT) principle was used for primary analysis.ResultsBaseline characteristics were identical in both groups (P>0.05). The cumulative 48 hours postoperative butorphanol consumption via PCA was 3.01.4 mg in the BR group (n=58), and 7.11.2 mg in the R group (n=58) (P<0.001). Overall cumulative opioid demand was lower at different time intervals in the BR group (P<0.001), along with the estimated median time of first analgesia demand via PCA (3.3 hours in the BR group and 1.6 hours in the R group). Visual Analogue Scale (VAS) score at movement and rest were also significantly lower until 3 months and 6 weeks, respectively. No side effects or adverse events associated with the intervention were observed in this study.ConclusionsPreemptive analgesia with betamethasone and ropivacaine provides better postoperative pain management following laminoplasty and laminectomy, compared to ropivacaine alone. This is an effective technique worthy of further evaluation.

Project description:Dexamethasone added to local anesthetic for brachial plexus block improves postoperative pain after arthroscopic rotator cuff repair, as compared with the use of local anesthetic alone. Dexamethasone is present in non-particulate form in local anesthetic solution, while betamethasone is partially present in particulate form. The particulate betamethasone gradually decays and is expected to cause its longer-lasting effect. This study investigated the postoperative analgesic effect of betamethasone added to ropivacaine for brachial plexus block in patients who underwent arthroscopic rotator cuff repair.This was a prospective, randomized, triple-blind study of 44 patients undergoing arthroscopic rotator cuff repair surgery. Ultrasound-guided interscalene brachial plexus block, involving 20 mL of 0.375 % ropivacaine (group R) or 19 mL of 0.375 % ropivacaine with 4 mg (1 mL) of betamethasone (group BR), was administered and surgery was performed under general anesthesia. After surgery, the pain score was recorded at 12 h after surgery, and on the first, second, and seventh postoperative day. Analgesia duration, offset time of motor block, frequency of rescue analgesic administration, postoperative nausea/vomiting, and sleep disturbance during the night after surgery were recorded. The numerical values were expressed as median [interquartile range]. P values < 0.05 were considered statistically significant.The duration of analgesia was significantly prolonged in group BR (group BR: 19.1 h [16.6, 20.9 h], group R: 13.3 h [11.6, 16.5 h], p < 0.001). The pain scores at 12 h after surgery and on the first and seventh day after surgery were significantly lower in group BR than in group R. The duration of motor block was significantly prolonged in group BR. The frequency of rescue analgesic administration and the sleep disturbance rate were significantly lower in group BR. There was no difference in postoperative nausea/vomiting between the two groups.Betamethasone added to local anesthetic in interscalene brachial plexus block improved postoperative pain after arthroscopic rotator cuff repair, and betamethasone prolonged the duration of analgesia by almost 6 h.University Hospital Medical Information Network Center Clinical Trials Registration System ( UMIN000012899 ).

Dataset Information

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

Publications

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

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