Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy

March 12, 2023 updated by: Fang Luo, Beijing Tiantan Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for surgery under general anaesthesia for laminectomy or laminoplasty;
  • American Society of Anaesthesiologists (ASA) classification of I or II;
  • Age 18 to 64 years;
  • Participates with an anticipated full recovery within 2 hours postoperatively.

Exclusion Criteria:

  • Patient refusal;
  • Participants who cannot use a patient-controlled analgesia (PCA) device and cannot understand the instructions of a Visual Analogue Score (VAS);
  • Previous history of spinal surgery;
  • Allergy to opioids, betamethasone or ropivacaine;
  • Peri-incisional infection;
  • History of stroke or a major neurological deficit;
  • Trauma, deformity;
  • Psychological problems;
  • Extreme body mass index (BMI) (< 15 or > 35);
  • History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
  • Patients using systemic steroids;
  • Pregnant or breastfeeding;
  • Preoperative Glasgow Coma Scale < 15;
  • Participants who have received radiation therapy or chemotherapy preoperatively, or with a high probability to require a postoperative radiation therapy or chemotherapy according to the preoperative imaging.
  • Not able to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The Treatment Group
The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine.
Drug: The Treatment group
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.
Active Comparator: The Control group
The local infiltration solution in the control group will consist of ropivacaine.
Drug: The Control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The cumulative butorphanol dose during the 48 hours after surgery via the PCA device.
Time Frame: Within 48 hours after the operation
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.
Within 48 hours after the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The total times that participants press patient-controlled analgesia button
Time Frame: Within 48 hours after the operation
The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Within 48 hours after the operation
The first analgesia demand on the PCA device
Time Frame: Within 48 hours postoperatively
The time from the end of the surgery to the first administration of analgesia via the PCA device
Within 48 hours postoperatively
Patient Satisfaction Score (PSS)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 4 weeks, 6 weeks, 3 months and 6 months after surgery
The Patient Satisfaction Score (PSS): 0 for unsatisfactory, and 10 for very satisfied
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 4 weeks, 6 weeks, 3 months and 6 months after surgery
The Postoperative Nausea and Vomiting (PONV)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
The Postoperative Nausea and Vomiting (PONV) will be measured using an ordinal scale, with 0 indicating no nausea; 1, mild nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting.
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Ramsay Sedation Scale (RSS)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
The Ramsay Sedation Scale (RSS): A 6-point scale will be used to assess sedation levels, with 1 indicating agitated, anxious; 2, cooperative; 3, only responds to commands; 4, strong response to glabellar tapping or noisy stimulants; 5, weak response to glabellar tapping or noisy stimulants; 6, no response.
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores
Time Frame: At 6 months postoperatively
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) scores will be used to obtain scores for four domains related to quality of life: physical health (7 items), psychological (6 items), social relationships (3items) and environment (8items). It will also include two stand-alone questions on overall quality of life and satisfaction with health. Each question will be rated on a scale of 1-5 with higher scores signifying better quality of life.
At 6 months postoperatively
The Oswestry Disability Index (ODI)
Time Frame: Preoperatively and at 4 weeks, 6 weeks and 3 months, 6 months after surgery.
Functional disability will be assessed by the Oswestry Disability Index. It includes 10 questions about pain and activities of daily living. Each item has five response categories from no pain related disability (0), to the worst possible pain disability (100). The ODI has been reported to be the most widely used and validated outcome measure in spinal surgery.
Preoperatively and at 4 weeks, 6 weeks and 3 months, 6 months after surgery.
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
Time Frame: At 6 months postoperatively
The Patient and Observer Scar Assessment Scale includes subjective symptoms of pain and pruritus and consists of 2 numerical scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It assesses vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). and it incorporates patient assessments of pain, itching, color, stiffness, thickness, relief and overall opinion. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin)
At 6 months postoperatively
The Visual Analogue Scale (VAS) during movement (VASm)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
The pain will be assessed by the visual analogue scale (VAS) scores: an 11-point VAS score during movement (VASm) will be recorded (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
The Visual Analogue Scale (VAS) at rest (VASr)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.
The pain will be assessed by the visual analogue scale (VAS) scores: an 11-point VAS score at rest (VASr) will be recorded (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours, and 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months and 6 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY 2019-112-02-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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