Bupivacaine Hydrochloride for Labor Pain

Phase-Based Estimates
3
Effectiveness
3
Safety
Brigham and Women's Hospital, Boston, MA
Labor Pain+1 More
Bupivacaine Hydrochloride - Drug
Eligibility
18 - 65
Female
Eligible conditions
Labor Pain

Study Summary

This study is evaluating whether a specific dose of a local anesthetic may help reduce pain for women during labor.

See full description

Eligible Conditions

  • Labor Pain
  • Analgesia

Treatment Effectiveness

Effectiveness Estimate

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

Study Objectives

This trial is evaluating whether Bupivacaine Hydrochloride will improve 1 primary outcome in patients with Labor Pain. Measurement will happen over the course of 30 min.

30 min
Numerical Rating Score < 3/10

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Epidural Technique
Dural Puncture Epidural Technique

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bupivacaine Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Dural Puncture Epidural Technique
Drug
Laboring women receiving the Dural Puncture Epidural (DPE) Technique with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Epidural Technique
Drug
Laboring women receiving the Conventional Epidural Technique (EPL) with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 min
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 min for reporting.

Who is running the study

Principal Investigator
L. C. T.
Prof. Lawrence Ching Tsen, Associate Professor of Anesthesia
Brigham and Women's Hospital

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Singleton, vertex gestation at term (38-42 weeks)
Less than 5 cm dilation
Parturient with no major co-morbidities
Desire to receive epidural labor analgesia
Numerical Rating Scale > 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.

Patient Q&A Section

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

What are common treatments for labor pain?

Add answer

In this pilot study, the use of an epidural for labor pain decreased the duration of labor, but the effect was less than anticipated. Other studies need to be conducted to determine if this effect is permanent.

Unverified Answer

What is labor pain?

Add answer

Labor pain can be classified into two subtypes. Contractions that stop within 1 hour post-delivery are termed postpartum pain and those over 1 hour post-delivery as postpartum pain.

Unverified Answer

Has bupivacaine hydrochloride proven to be more effective than a placebo?

Add answer

There were no significant differences between the mean VAS scores for the bupivacaine group when compared to the placebo at 2, 4, and 8 h. More importantly, there were no adverse effects in terms of nausea, vomiting, or pain and nausea scores.

Unverified Answer

How many people get labor pain a year in the United States?

Add answer

About 70,000 women will be in labor, experiencing labor pain, every year in the United States. This figure includes those suffering from spontaneous miscarriage and premature birth. About 33,000 will have severe labor pain requiring admission to a hospital (for example the woman will need medical assistance due to severe back pain or choriocarcinoma).

Unverified Answer

What causes labor pain?

Add answer

Women suffering from pain during the labor process are likely suffering from a number of things, including anxiety and discomfort related to the process, preexisting medical diagnoses and the actual birthing process, and a traumatic birth, which could all cause pain related to labor. Doctors, in an effort to keep patients out of hospital and out of pain, often try to treat pain by giving them more epidural blocks; this is the main reason for the current [trend] of 'injecting too much morphine'.

Unverified Answer

What are the signs of labor pain?

Add answer

Pain during labour is relatively common and can occur with or without rupture of membranes. It can appear as a dull, dull ache in the lower abdomen that may be constant or worsen over time.

Unverified Answer

Can labor pain be cured?

Add answer

Unfortunately, labor pain can not be fully alleviated by medication, but some pain can be minimized and tolerable by educating women and using techniques including active support and education, massage, relaxation, exercise, and dietary adjustments.

Unverified Answer

What is bupivacaine hydrochloride?

Add answer

This review concludes that bupivacaine may be of value as a local anesthetic adjuvant in obstetric procedures. The evidence does not allow a conclusive answer regarding its value during labor. Further prospective studies are needed to better assess the safety of bupivacaine in human pregnancies.

Unverified Answer

How does bupivacaine hydrochloride work?

Add answer

It was demonstrated the analgesic effect of bupivacaine after its intrathecal application into the lumbar region. Pain scores at both 1 and 30 minutes of application were lower than analgesic efficacy of the 2% chloroform bupivacaine intrathecal application.

Unverified Answer

What does bupivacaine hydrochloride usually treat?

Add answer

Findings from a recent study show that bupivacaine hydrochloride can reduce pain, particularly when combined with lidocaine, pethidine and cyclobenzaprine but can worsen analgesia when combined with epinephrine or ketamine in the epidural space and in lower concentrations has been proven to cause analgesia in anesthesiology, with or without morphine in the spinal fluid.

Unverified Answer

Is bupivacaine hydrochloride safe for people?

Add answer

There are no new reports of long-term adverse events following peripheral nerve block with bupivacaine hydrochloride for labour analgesia. This is consistent with studies, which demonstrated effectiveness of high doses of bupivacaine for caesarean section.

Unverified Answer

Have there been any new discoveries for treating labor pain?

Add answer

While no new discoveries in labor pain treatment were reported, the authors did recommend that future investigations should focus on developing new treatments. As new data on the mechanisms of labor pain are emerging, we anticipate the search for new treatments will continue.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Labor Pain by sharing your contact details with the study coordinator.