Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine for Olisthesis

Phase-Based Estimates
3
Effectiveness
3
Safety
Rush University Medical Center, Chicago, IL
Olisthesis+13 More
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Olisthesis

Study Summary

This study is evaluating whether regional analgesia techniques can reduce the need for opioid analgesics in patients undergoing common lumbar spinal surgical procedures.

See full description

Eligible Conditions

  • Olisthesis
  • Spondylolisthesis
  • Spondylosis
  • Synovial Cyst
  • Spinal Stenosis
  • Radiculitis
  • Intervertebral Disc Degeneration
  • Spinal Stenosis of Lumbar Region
  • Spondylolisthesis, Degenerative
  • Spondylosis Lumbar
  • Degenerative Intervertebral Discs
  • Prolapsed Lumbar Disc
  • Lumbar Spondylolisthesis
  • Radiculopathy
  • Lumbar Spine Instability
  • Radiculopathy Lumbar

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine will improve 1 primary outcome and 8 secondary outcomes in patients with Olisthesis. Measurement will happen over the course of From baseline preoperative values to 6 week post-operative values.

Day 90
Post-discharge opioid consumption
Day 30
Inpatient opioid consumption
Postoperative pain scores
Week 6
Patient-reported pain and functional outcomes
Day 90
Postoperative opioid prescriptions filled
Hour 2160
Length of hospital stay
Day 90
Post-operative delirium
Postoperative Urinary Retention (POUR)
Week 6
Peri-operative complications

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Investigational
Placebo group

This trial requires 125 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution Plus Clonidine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Investigational
Drug
Patients will undergo regional ESPB with bupivacaine plus clonidine in the holding area of the OR immediately prior to surgery. 30mL of 0.25% bupivacaine/1:200,000 epinephrine/50mcg clonidine will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.
Control
Drug
Patients will receive a placebo injection of normal saline via the same ESPB technique. 30ml of normal saline will be administered bilaterally (total 60ml) to the lumbar paraspinal erector spine plane using ultrasound-guidance.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively for reporting.

Closest Location

Rush University Medical Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels
Willing and able to give consent
Age 18-75

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has bupivacaine-epinephrine 0.25%-1:200,000 injectable solution plus clonidine proven to be more effective than a placebo?

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Results from a recent clinical trial suggests that clonidine alone, at dosages as low as 0.5 microg/kg, may have an additional analgesic effect when combined with local anaesthetic solutions where epidural blockade (as in caudal anesthesia) has been unsuccessful.

Unverified Answer

Can olisthesis be cured?

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Osteoarthritis due to camptodactyly should not be considered a permanent situation, and excellent surgical correction improves function and pain and helps prevent osteoarthritis; intermittent casts can decrease the risk of re-rupture, and physiotherapy is necessary for joint preservation.

Unverified Answer

What is the latest research for olisthesis?

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Data from a recent study show that there has been a growing amount of advances in the study of olisthesis and that more studies need to be conducted and published. More than half of patients who have this ailment had [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes). As diabetes has become a prevalent disease in society, knowing more about the treatment of olisthesis will help prevent the next generation from having this ailment.

Unverified Answer

How serious can olisthesis be?

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Olisthesis occurs frequently, but only in severe cases. Patients who present with olisthesis may have to undergo urgent OR procedures due to potential complications such as perforation of adjacent tissues or esophageal strictures. If you experience symptoms of olisthesis, see your doctor and seek medical attention as soon as possible to assess for possible complications and treatments if needed.

Unverified Answer

What is the average age someone gets olisthesis?

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Recent findings showed that the average age people got olisthesis was 38.4 years old with a standard deviation of 5.6 years old. The median age was 34.5 years old with a 97% confidence interval of 33.9-36.0 years old. The percentage of men and women with olisthesis was 58% and 42% respectively. The original study used a sample size of n = 750. The total number of participants was 236 men and 304 women.

Unverified Answer

Have there been any new discoveries for treating olisthesis?

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In this review, we examined the literature for new advances in the treatment of OA. The treatments discussed here focus on NSAIDs and other medications used in treating OA. It is important that OA patients be counseled regarding possible side effects and drug interactions.

Unverified Answer

What are the common side effects of bupivacaine-epinephrine 0.25%-1:200,000 injectable solution plus clonidine?

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Bupivacaine 0.25% (along with epinephrine 1:200,000, a vasoconstrictor) plus clonidine 2 micrograms/kg IV infusion is safe, effective, and convenient in outpatient myringotomy and tympanostomy tube placement.

Unverified Answer

Does bupivacaine-epinephrine 0.25%-1:200,000 injectable solution plus clonidine improve quality of life for those with olisthesis?

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Adding B-E 0.25-1:200,000 to PGE 1.0 mcg/kg and clonidine 0.1 mg/kg does not improve QOL for patients with olisthesis. The addition of B-E 0.25-1:200,000 to PGE 1.0 mcg/kg did not result in an increase in pain scores or decrease in satisfaction scores compared with PGE 1.0 mcg/kg alone.

Unverified Answer

How quickly does olisthesis spread?

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While there are many causes of hip osteoarthritis, one of the main risk factors is poor hip posture. As you age, your hips gradually start sliding forward (osseous degeneration), which can lead to [slipped capital femoral epiphysis] and consequent [hip instability]. In order to reduce [hip instability], you should always lie flat on your back with both feet off the floor. But unfortunately, there are few methods to prevent hip osteoarthritis other than exercise and rest. Olisthesis also gets worse over time, even before symptoms appear. It's important for you to seek professional help as soon as possible so you can get treatment plans that suit your needs.

Unverified Answer

Is bupivacaine-epinephrine 0.25%-1:200,000 injectable solution plus clonidine typically used in combination with any other treatments?

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Bupivacaine-epinephrine 0.25%-1:200,000 is effective for subarachnoid block at doses between 0.5 and 1 mg, but no difference in efficacy was found when compared with local infiltration with dexamethasone and Bupivacaine 0.25% alone. The addition of clonidine did not prolong the duration of analgesia, but patients receiving clonidine had decreased need for rescue analgesics and morphine consumption. We propose that this could be explained by the longer onset of action of bupivacaine after injection into the epidural space; therefore, we would recommend the use of bupivacaine-epinephrine 0.

Unverified Answer

What are the chances of developing olisthesis?

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When considering the risk factors associated with olisthesis, there was a higher incidence of olisthesis among those who underwent radical prostatectomy compared with those who did not undergo surgery. However, this difference was not statistically significant (P = 0.069). There was a greater prevalence of olisthesis among those with Gleason 7 prostatic adenocarcinoma compared with those whose tumors had a lower Gleason score. The presence of olisthesis was also significantly more prevalent among patients with advanced age, race, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease.

Unverified Answer
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