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Nerve Block vs Local Anesthetic for Postoperative Pain

N/A

Recruiting

Led By Rashmi Mueller, MD

Research Sponsored by Rashmi Mueller

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: Greater than 18 years but less than 80

Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)

Must not have

Emergency surgery

Major liver or kidney dysfunction or other pre-existing major organ dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-operation score to 1 day after surgery date

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different ways of managing pain after surgery. One group will receive a specific nerve block before surgery, another group will get a lot of numbing medication after surgery, and a third

Who is the study for?

This trial is for adults aged 18-80 who have not regularly used opioids (less than the equivalent of 6 oxycodone pills per day), are undergoing a planned non-emergency spinal fusion surgery between T8 and S2, and have no allergies or conditions that would prevent them from receiving local anesthetics or regional anesthesia procedures.

What is being tested?

The study compares two pain control methods after spinal surgery: one group receives an erector spinae block before surgery, another gets local anesthetic infiltration at the end of surgery, and a control group has general anesthesia without regional anesthesia. Pain levels, inflammation markers, opioid use, and recovery assessments will be measured.

What are the potential side effects?

Potential side effects may include discomfort at injection sites, possible nerve damage from needle placement in ESP block procedure, allergic reactions to local anesthetics, reduced blood pressure or breathing issues related to regional blocks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19 and 79 years old.

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I take less than 6 oxycodone pills a day or its equivalent.

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I am having a planned spine surgery involving 1 to 2 levels between my mid-back and lower back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had emergency surgery.

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I do not have major liver, kidney, or other organ problems.

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I have a blood disorder or abnormal blood clotting tests.

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I have had a heart attack recently.

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My heart's pumping ability is severely reduced.

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I am scheduled for or have had a revision surgery.

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I have been taking a strong painkiller regularly for more than a week.

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I have a serious brain or lung condition, or I use oxygen at home.

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I have neurological issues before surgery.

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I had a cardiac stent placed within the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-operation score to 1 day after surgery date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-operation score to 1 day after surgery date

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-operation score to 1 day after surgery date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups

Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 1

Secondary study objectives

Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Group GA: General anesthesia onlyActive Control1 Intervention

This group receives general anesthesia only and surgical procedure will follow standard conditions.

Group II: Group ESP: Erector Spinae BlockActive Control1 Intervention

This group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision.

Group III: Group LIA: Local InfiltrationActive Control1 Intervention

This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated.

0 / 13Eligibility criteria met