Nerve Block vs Local Anesthetic for Postoperative Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rashmi Mueller
Must not be taking: Opioids
Disqualifiers: Organ dysfunction, Chronic pain, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic infiltration at the end of the procedure before emergence from anesthesia. The control group of subjects will undergo spinal surgery with general anesthesia but without any regional anesthesia. Outcome measurements include evaluation of serum inflammatory markers, pain scores, opioid usage and standardized evidence-based assessment methodologies.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are opioid tolerant or have narcotic dependence, you may not be eligible to participate.
What data supports the effectiveness of the treatment Erector Spinae Block for postoperative pain?
Research shows that the erector spinae plane block can effectively reduce pain after lumbar spinal surgery, as it has been compared favorably to wound infiltration and shown to improve pain relief in various studies.
12345Is the Erector Spinae Plane (ESP) Block safe for humans?
The available research does not specifically address the safety of the Erector Spinae Plane (ESP) Block, but it is a widely used technique for managing pain after surgery, suggesting it is generally considered safe in clinical practice.
14678How does the erector spinae plane block treatment differ from other treatments for postoperative pain?
The erector spinae plane block is a novel regional anesthesia technique that involves injecting a local anesthetic near the spine to block pain signals. Unlike traditional methods, it targets the origin of spinal nerves and can be used for a wide range of surgeries, offering a potentially safer and more effective alternative for managing postoperative pain.
256910Eligibility Criteria
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.Inclusion Criteria
I am not allergic to local anesthetics.
I take less than 6 oxycodone pills a day or its equivalent.
I am between 19 and 79 years old.
+1 more
Exclusion Criteria
I have had emergency surgery.
I do not have major liver, kidney, or other organ problems.
Significant psychiatric illnesses that impedes the subject's ability to provide informed consent
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Pre-procedure
Pre-procedure activities include survey evaluations and baseline evaluations such as social history, pain medication history, and pain rating
1 day
1 visit (in-person)
Treatment
Participants undergo thoraco-lumbar fusion surgery with different anesthesia protocols: ESP block, LIA, or GA only
1 day
1 visit (in-person)
Post-operative Monitoring
Pain control and opioid usage are monitored for the first 72 hours post-surgery, with survey evaluations during the first 7 days of hospital stay
7 days
Daily monitoring (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of delirium symptoms up to 3 days post-operation
3 days
2 visits (in-person)
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Iowa Health Care Medical CenterIowa City, IA
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Who Is Running the Clinical Trial?
Rashmi MuellerLead Sponsor
References
Efficacy of erector spinae plane block for postoperative analgesia lumbar surgery: a systematic review and meta-analysis. [2023]The erector spinae plane (ESP) block is a newly defined regional anesthesia technique first described in 2016. The aim of this meta-analysis is to assess the efficacy of ESP block in improving analgesia following lumbar surgery.
Bilateral ultrasound-guided erector spinae plane block versus wound infiltration for postoperative analgesia in lumbar spinal fusion surgery: a randomized controlled trial. [2023]Both erector spinae plane block and wound infiltration are used to improve analgesia following spinal fusion surgery. Herein, we compared the analgesic effect of bilateral erector spinae plane block with wound infiltration in this patient population.
Comparison of the feasibility and validity of a one-level and a two-level erector spinae plane block combined with general anesthesia for patients undergoing lumbar surgery. [2023]Spinal surgery causes severe postoperative pain. An erector spinae plane (ESP) block can relieve postoperative pain, but the optimal blocking method has not been defined. The aim of this study is to compare the feasibility of a one-level and a two-level lumbar ESP block and their effect on intraoperative and postoperative analgesia in lumbar spinal surgery.
Pharmacokinetics of lidocaine after bilateral ESP block. [2021]Erector spinae plane (ESP) block is an emerging interfascial block with a wide range of indications for perioperative analgesia and chronic pain treatment. Recent studies have focused their attention on mechanisms of action of ESP block. However, the pharmacokinetics of drugs injected in ESP is, as of now, uninvestigated. The aim of this brief report is to investigate the pharmacokinetics of lidocaine in a series of 10 patients.
Bilateral Erector Spinae Plane Block for Surgery on the Posterior Aspect of the Neck: A Case Report. [2021]The erector spinae plane block is an interfascial plane block whereby local anesthetic is injected within the plane deep to the erector spinae muscle and superficial to the transverse process. To date, it has been used to provide analgesia in thoracic, abdominal, and lumbar regions. We present the first reported case of bilateral erector spinae plane block being used to provide surgical anesthesia in the cervical region.
Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. [2021]Erector spinae plane (ESP) block is a novel regional anesthesia technique and gaining importance for postoperative pain management. Since it was first described, the clinicians wonder if this new simple technique can replace paravertebral block (PVB). We aimed to compare the postoperative analgesic effect of ESP block and PVB with a control group in breast surgeries.
Evaluation of Sensory Mapping of Erector Spinae Plane Block. [2020]Erector spinae plane (ESP) block is an effective regional analgesic technique for thoracic and abdominal pain. The volume of local anesthetic (LA) needed to produce sensory block in the spinal segment is unknown.
Erector spinae plane block: a systematic qualitative review. [2022]The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia for chronic thoracic pain. It consists in an injection of local anesthetic in a plane between the transverse process and the erector spinae muscles group.
Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. [2020]Erector spinae plane (ESP) block is an interfascial plane block where a local anaesthetic is injected in a plane preferably below the erector spinae muscle. It is supposed to work at the origin of spinal nerves based on cadaveric and contrast study. It has emerged as an effective and safe analgesic regional technique. It has a wide variety of applications ranging from control of acute postoperative pain to chronic pain. In this series, we report a series of six cases, which include postoperative pain management in breast, thoracic, and abdominal surgeries along with management of two chronic pain cases to illustrate the potential uses of continuous and single-shot ESP block.
Ultrasound-guided Low Thoracic Erector Spinae Plane Block for Effective Postoperative Analgesia after Lumbar Surgery: Report of Five Cases. [2020]Pain control is an important administration of postoperative management in lumbar spinal surgery, and multimodal analgesia is most likely an important strategy in reducing postoperative spinal surgery. Erector spinae plane (ESP) block is a recently described regional anaesthesia technique that blocks the dorsal and ventral rami of the spinal nerves and the sympathetic nerve fibers. While the ESP block has been shown to provide effective postoperative analgesia after thoracic, breast, and abdominal surgery in case reports and randomised controlled studies, there are only a few case series that report that an ultrasonography (US)-guided bilateral ESP block provides effective postoperative analgesia in lumbar surgery. We report five patients undergoing lumbar surgery in which a bilateral lower thoracic ESP block was used as the postoperative analgesia. The bilateral ESP block may be a promising anesthetic method for postoperative analgesia following lumbar surgery. Our aim is testing the safety and efficacy of this technique in various surgical procedures by conducting prospective studies.