Intrathecal vs Epidural Fentanyl for Itching

Overseen By Aymen Messadaa, MD, Anesthesiology

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Must not be taking: Opioids

Disqualifiers: ASA score ≥ 3, BMI > 40, others

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

Compensation: Varies

Number of Visits: 15

Duration: 5 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which method of pain relief during labor causes less itching. It compares two ways to administer fentanyl, a powerful painkiller: intrathecal (injected into the spinal fluid) and epidural (injected around the spinal cord). The goal is to determine if the epidural method results in less itching, a common side effect, to make labor more comfortable. Women who are full-term (37 weeks or more) and planning a vaginal delivery with spinal pain relief might be suitable candidates. As an unphased trial, this study allows participants to contribute to important research that may enhance comfort during labor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been given opioids before, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both intrathecal and epidural fentanyl are generally safe but can cause itching. Studies indicate that intrathecal fentanyl effectively reduces pain but often leads to itching, with rates ranging from 15% to 70%. Other side effects may include nausea or mild breathing issues, similar to those with other opioid treatments.

Epidural fentanyl also has a notable chance of causing itching, occurring in about 30% of cases. Both treatments share similar side effects because they are types of spinal or epidural opioids. While itching can be bothersome, it is a known and manageable side effect. Patients should always consult a healthcare provider to understand the benefits and any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore two different methods of fentanyl administration to manage itching, a common side effect. Unlike traditional approaches that might not effectively address itchiness caused by opioids, this trial compares intrathecal and epidural delivery. Intrathecal administration involves delivering fentanyl directly into the spinal fluid, potentially providing quicker relief, while epidural administration targets the epidural space to possibly offer a more sustained effect. By examining these two approaches, researchers hope to determine which method is more effective at minimizing itching, paving the way for improved patient comfort.

What evidence suggests that this trial's treatments could be effective for reducing itching in laboring women?

This trial will compare intrathecal (spinal) fentanyl with epidural fentanyl for pain relief during labor to determine which method might cause less itching. Research has shown that fentanyl, whether administered intrathecally or epidurally, often causes itchiness. Studies have found that intrathecal fentanyl can cause itching in 40% to 100% of patients. For epidural fentanyl, about 78% of patients experience itching on average. Both methods effectively relieve pain, but itching remains a common side effect. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for laboring women who need pain relief and are considering spinal or epidural analgesia. The study will focus on the itchiness that can happen with these treatments. Specific eligibility criteria were not provided, so participants should consult with the research team to determine if they qualify.

Inclusion Criteria

I am 18 years old or older.

Vaginal delivery

French or English language

Exclusion Criteria

I am allergic or cannot take certain pain medications like morphine or fentanyl.

ASA score ≥ 3

BMI > 40 kg/m²

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either intrathecal fentanyl or epidural fentanyl for labor analgesia

5 hours

Continuous monitoring during labor

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours

Monitoring every 15 minutes for the first hour, then hourly for 5 hours

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Analgesia
• Spinal analgesia

Trial Overview

The study compares two methods of pain relief during labor: intrathecal fentanyl (spinal analgesia) versus epidural fentanyl (epidural analgesia). It aims to find out which method leads to less itchiness, a common side effect of opioid use in childbirth.

How Is the Trial Designed?

Group I: Spinal Active Control 1 Intervention

Intrathecal fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + Fentanyl 15mcg And epidural Nacl 0.9%

Group II: Epidural Active Control 1 Intervention

Epidural fentanyl This group will receive intrathecal Bupivacaïne 0.25% 1ml + NaCl 0,9% And epidural fentanyl 100mcg

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3788225/

Neuraxial opioid-induced pruritus: An update - PMC

Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. Sometimes it may be more unpleasant than pain itself.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091217341910

Effect of prophylactic 5-HT3 receptor antagonists on ...

Pruritus after neuraxial opioids was reported in all trials. The incidence of pruritus was 78% (range, 57–100%) in the control group, 80% with neuraxial ...

3.

jtd.amegroups.org

jtd.amegroups.org/article/view/99392/html

Nalmefene effectively relieves thoracic epidural opioid ...

The primary outcome was the complete relief rate of pruritus within 24 hours after the treatment. Secondary outcomes included postoperative pain ...

4.

journals.lww.com

journals.lww.com/anesthesia-analgesia/fulltext/1999/02001/epidural_fentanyl_induced_pruritus_.249.aspx

epidural-fentanyl-induced pruritus: self-administered versus

Patient-administered IV naloxone enhanced patient control of treatment of epidural fentanyl-induced itching and decreased need for hospital staff intervention.

5.

bjanaesthesia.org.uk

bjanaesthesia.org.uk/article/S0007-0912(23)00316-1/fulltext

a systematic review and Bayesian network meta-analysis

Secondary outcomes explored from the pooled data were number of patients who developed pruritus and needed intervention to alleviate it. In the ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0952818002005019

Neuraxial opioid-induced pruritus: a review

When intrathecal and epidural opioids are administered, pruritus occurs as an unwanted and troublesome side effect. The reported incidence varies between 30% ...

7.

journals.lww.com

journals.lww.com/md-journal/fulltext/2019/10040/incidence_and_risk_factors_for_epidural_morphine.41.aspx

Incidence and risk factors for epidural morphine induced...

The incidence of pruritus after intrathecal morphine administration is reported to be as high as 85% in parturients, and that by epidural morphine varies ...

8.

e-century.us

e-century.us/files/ijcem/9/10/ijcem0029283.pdf

Review Article The effects of prophylactic ondansetron on ...

Abstract: Objective: The aim of this meta-analysis is to evaluate the effect of ondansetron in the prevention of pruritus after use of intrathecal fentanyl.

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1098733901196276

Intrathecal fentanyl-induced pruritus is more severe in ...

Pruritus is the most common side effect. When using procaine as a substitute for lidocaine, we perceived an increased frequency and severity of pruritus. We ...