SPG Nerve Block for Postoperative Pain

Overseen By Cameron R Smith, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must not be taking: Opioids

Disqualifiers: Chronic pain, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific nerve block technique can reduce pain and the need for opioids after sinus surgery, specifically septorhinoplasty. Participants will receive either a combination of ropivacaine (a numbing medication) and dexamethasone or a placebo with dexamethasone to compare their effects. The goal is to improve pain management after surgery and reduce the side effects associated with opioid use. This trial suits those undergoing septorhinoplasty who can eat and drink normally before surgery and have no ongoing pain issues or recent opioid use. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants the chance to contribute to understanding its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have been using opioids regularly in the past 3 months, you would not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that using ropivacaine and dexamethasone together for nerve blocks is generally safe. Dexamethasone, a type of steroid, enhances the effectiveness of local anesthetics like ropivacaine for pain relief. Studies have found that this combination is well-tolerated and can reduce the need for opioids, which are strong painkillers with potential side effects.

In past studies, ropivacaine has been used safely in various surgeries as a local anesthetic, numbing a specific area to prevent pain. When combined with dexamethasone, it improved pain control and reduced opioid-related side effects.

Overall, this treatment has been used safely before, with few reports of serious problems. It is important to remember that this information is based on past studies, and individual experiences may vary. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using the SPG nerve block with ropivacaine and dexamethasone for postoperative pain because of its targeted approach. Unlike standard pain relief methods like opioids or NSAIDs, which work broadly throughout the body, this treatment uses a precise ultrasound-guided injection to deliver medication right to the source of pain in the pterygopalatine fossa. This localized delivery could mean quicker and more effective pain relief with potentially fewer side effects. Additionally, adding dexamethasone may enhance the duration of pain relief, offering a longer-lasting solution compared to traditional options.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

In this trial, participants will receive different treatments to manage postoperative pain. Research has shown that ropivacaine, administered to Group 1 along with dexamethasone, reduces pain after surgery, lowering pain levels and decreasing the need for additional pain medication. Dexamethasone, included in both Group 1 and Group 2, also aids in pain relief and can reduce opioid use by up to 30% in some cases. Together, these treatments are expected to manage pain effectively after surgeries like septorhinoplasty, providing better pain control and speeding up recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeffrey D Johnson, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who are undergoing septorhinoplasty, can eat and drink normally before surgery, and have a physical status classified as ASA 1-3. It's not for those allergic to opioids, with chronic pain or ongoing opioid use, needing additional surgeries, pregnant women, without mobile texting capabilities, or deemed unsuitable by the study team.

Inclusion Criteria

My health is good to moderately impaired.

Normal oral food and water intake before surgery

I am planning to undergo nose surgery.

Exclusion Criteria

I need another surgery besides septorhinoplasty.

If the study team thinks that you are not a good fit for the treatment, you will not be able to participate.

I am allergic to opioid pain medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo septorhinoplasty surgery with either Ropivacaine plus Dexamethasone or Placebo plus Dexamethasone administered via a suprazygomatic approach

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative pain and opioid use reduction

7 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Placebo
• Ropivacaine

Trial Overview

The study tests if nerve blocks in the pterygopalatine fossa using Ropivacaine and Dexamethasone reduce post-operative pain and opioid use after septorhinoplasty compared to a placebo. This randomized double-blind trial hypothesizes less pain and morbidity with this technique.

How Is the Trial Designed?

Group I: Group 1: Ropivacaine plus Dexamethasone Experimental Treatment 2 Interventions

The group 1 injection procedure will be performed as follows: after preparation of the skin using appropriate skin preparation solution and using aseptic technique, a small-gauge spinal needle will be advanced into the pterygopalatine fossa under ultrasound guidance. Once the needle is properly positioned, 0.5% ropivacaine will be administered at a dose of 20 mg plus 4 mg dexamethasone and the needle will be removed. This procedure will be performed bilaterally

Group II: Group 2: Placebo plus Dexamethasone Active Control 2 Interventions

In group 2 the same procedure will be performed, but the injectate will consist of 5 mL of a balanced crystalloid intravenous solution (4 ml of normal saline) plus 4 mg dexamethasone (each side). This procedure will be performed bilaterally.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

In a study of 90 patients undergoing craniotomy, adding dexamethasone to local anesthetics did not significantly improve postoperative pain management or reduce the need for analgesics compared to a saline control.

The use of dexamethasone as an adjuvant in scalp nerve blocks did not affect intraoperative opioid requirements, time to wake from anesthesia, or the incidence of postoperative nausea and vomiting, suggesting it may not enhance the effectiveness of local anesthetics in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Studying the Role of Dexamethasone in Scalp Nerve Blocks for Supratentorial Craniotomy. Jose, R., Chakravarthy, K., Nair, S., et al.[2017]

Adding dexamethasone (8 mg) to bupivacaine and ropivacaine significantly prolongs the time until patients need their first rescue analgesic, with times of 1205 minutes for bupivacaine and 1211 minutes for ropivacaine compared to much shorter times with the anesthetics alone.

The combination of dexamethasone with ropivacaine not only enhances the duration of analgesia (928.66 minutes) but also leads to a faster onset and longer-lasting sensory and motor block compared to bupivacaine with dexamethasone (840.5 minutes).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dexamethasone on Characteristics of Supraclavicular Nerve Block with Bupivacaine and Ropivacaine: A Prospective, Double-blind, Randomized Control Trial. Bindal, D., Narang, N., Mahindra, R., et al.[2022]

In a study of 70 adult patients undergoing lower abdominal surgeries, adding 8 mg of dexamethasone to 20 ml of 0.25% ropivacaine significantly prolonged the duration of analgesia and reduced pain scores compared to ropivacaine alone.

Patients receiving the dexamethasone-ropivacaine combination also consumed less morphine for pain relief, while the incidence of nausea and vomiting was similar between both treatment groups, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Ropivacaine and Ropivacaine with Dexamethasone in Transverse Abdominis Plane Block for Lower Abdominal Surgeries: A Prospective, Randomized, Double-Blinded Study. Gnanasekar, N., Kumar, GD., Kurhekar, P., et al.[2022]

In a study involving 60 female patients undergoing unilateral radical mastectomy, adding 8 mg of dexamethasone to ropivacaine 0.2% did not reduce opioid consumption or prolong analgesia compared to ropivacaine alone.

The duration of pain relief and the overall pain scores (measured by VAS) were similar between the two groups, indicating that dexamethasone may not provide additional benefits in this specific nerve block setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of dexamethasone as a perineural additive to ropivacaine for PECS II blockade in patients undergoing unilateral radical mastectomy - A prospective, randomized, controlled and double-blinded trial. Hoerner, E., Gasteiger, L., Ortler, M., et al.[2022]

In a study of 60 patients undergoing knee arthroscopy, adding dexamethasone to bupivacaine significantly prolonged the duration of sensory block from 12.52 hours to 17.42 hours, enhancing postoperative pain management.

Patients receiving dexamethasone reported higher satisfaction scores and required analgesics later compared to the control group, indicating that dexamethasone improves both pain relief and overall patient experience after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Ibrahim, AS., Aly, MG., Farrag, WS., et al.[2019]

In a study involving 60 patients undergoing inguinal herniorrhaphy, a single dose of 10 mg dexamethasone did not improve pain relief or reduce the incidence of postoperative nausea and vomiting (PONV) after spinal anesthesia with tetracaine and neostigmine.

The findings suggest that dexamethasone does not enhance the analgesic effects of neostigmine or decrease the severity of nausea and vomiting following intrathecal administration, indicating it may not be beneficial in this specific postoperative context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dexamethasone on postoperative pain and emesis after intrathecal neostigmine. Tan, PH., Liu, K., Peng, CH., et al.[2022]

In a study involving 89 adult patients undergoing shoulder arthroscopy, the addition of low doses of dexamethasone (1-2 mg) to bupivacaine significantly prolonged the duration of pain relief from 12.1 hours to around 22-23 hours.

Both 1 mg and 2 mg doses of dexamethasone provided similar analgesic effects as the higher 4 mg dose, indicating that lower doses can be just as effective for enhancing pain management in nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a dose response of dexamethasone as adjuvant for supraclavicular brachial plexus nerve block? A prospective randomized double-blinded clinical study. Liu, J., Richman, KA., Grodofsky, SR., et al.[2022]

In a study of 60 patients undergoing supraclavicular brachial plexus block, adding 8 mg of dexamethasone to levobupivacaine significantly prolonged the time until the first rescue analgesia was needed, from about 396 minutes to 706 minutes.

The combination of dexamethasone and levobupivacaine not only delayed the need for additional pain relief but also resulted in a faster onset and longer duration of both sensory and motor block compared to levobupivacaine alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical comparison between 0.5% levobupivacaine and 0.5% levobupivacaine with dexamethasone 8 mg combination in brachial plexus block by the supraclavicular approach. Pani, N., Routray, SS., Mishra, D., et al.[2022]

In a pilot study involving 49 patients undergoing foot and ankle surgery, the addition of 8 mg dexamethasone to nerve blocks did not significantly improve the duration of pain relief or reduce the incidence of postoperative neuropathic complications compared to nerve blocks alone.

The study suggests that while dexamethasone is commonly used to enhance pain management, its effectiveness in this context remains uncertain, indicating the need for further research with a larger sample size to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Addition to Popliteal Nerve Blocks: Effects on Duration of Analgesia and Incidence of Postoperative Nerve Complication. Noori, N., Anand, K., Pfeffer, G., et al.[2021]

In a study of 79 patients undergoing upper extremity surgery, the addition of dexamethasone to a brachial plexus nerve block significantly prolonged the duration of analgesia compared to ropivacaine alone.

Dexamethasone at a low dose of 1 mg was found to be as effective as a higher dose of 4 mg in prolonging the nerve block, indicating that lower doses can be used effectively for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Duration of Low-Dose Adjuvant Dexamethasone in Regional Anesthesia for Upper Extremity Surgery: A Prospective, Randomized, Controlled Blinded Study. Gouda, N., Zangrilli, J., Voskerijian, A., et al.[2023]

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SPG Nerve Block for Postoperative Pain · Info for Participants

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