Opioid-Free Labor Analgesia: Dexmedetomidine as an Adjuvant Combined with Ropivacaine

Journal of Healthcare Engineering, Volume 2022, Year 2022

Interpretation

Background. Side effects of the use of opioid analgesics during painless delivery are the main factors that affect rapid postpartum recovery. Opioid use can result in dangerous respiratory depression in the patient. Opioids can also disrupt the baby’s breathing and heart rate. The nonopioid analgesic dexmedetomidine, a new a2-adrenergic agonist, possesses higher selectivity, greater analgesic effects, and fewer side effects. Moreover, epidural administration of dexmedetomidine also reduces local anesthetic consumption. Objective. Our study aims to compare the analgesic effects as well as the side effects of ropivacaine with dexmedetomidine against sufentanyl as an epidural labor analgesia. Methods. This study is a randomized, double-blinded, controlled trial (registration no. ChiCTR2200055360) involving 120 primiparous (a woman who has given birth once), singleton pregnancy women who are greater than 38 weeks into gestation and have requested epidural labor analgesia. The participants were randomized to receive 0.1% ropivacaine with sufentanyl (0.4 μg/ml) or dexmedetomidine (0.4 μg/ml). The primary outcomes included Visual Analogue Score (VAS), duration of first epidural infusions, the requirement of additional PCEA bolus, and adverse reactions during labor analgesia. Results. Of the 120 subjects who consented, 91 parturient women (women in the condition of labor) had complete data for analysis. Demographics and VAS, as well as maternal and fetal outcomes, were similar between the groups. The duration of first epidural infusions in dexmedetomidine was significantly longer than sufentanyl (median value: 115 vs 68 min, P < 0.01); the parturient women who received dexmedetomidine and who required additional PCEA bolus were fewer in comparison to those who received sufentanyl (27.5% vs 49.0%, P < 0.05). Furthermore, the incidence of pruritus in the dexmedetomidine group was lower in comparison to the sufentanyl group (0% vs 11.8%, P < 0.05). Conclusions. Dexmedetomidine, a nonopioid, is superior to the opioid analgesic sufentanyl in providing a prolonged analgesic effect as an epidural during labor. It also reduces local anesthetic consumption and has fewer side effects. The trial is registered with ChiCTR2200055360. This study is a randomized, double-blinded, controlled clinical trial with registration no. ChiCTR2200055360 and is approved by the Inner Mongolia Baotou Maternity Hospital's Ethics Committee. Between January 2021 and August 2021, written informed permission was received from 120 study participants who requested epidural labor analgesia. Parturients were enrolled if they were considered as a physical status I or II (according to the American Society of Anesthesiologists), aged between 20 and 36 years, weighed less than 100 kg, carried a single fetus ≥38 weeks, and experienced cervical dilation ≥3 cm and ≤5 cm. The study exclusion criteria included patients with hypertensive disease, multiple gestations, and history of premature labors and patients with contraindications to epidural analgesia or allergies to opioids/local aesthetics, a history of chronic opioid analgesic use, and VAS ≥4 30 min after epidural labor analgesia. 120 patients were randomized in a balanced manner into two groups via a computer-generated random-number table: the sufentanyl group (Group S, n = 60) and the dexmedetomidine group (Group D, n = 60). All parturients who met the inclusion criteria were established with venous access and had their vital signs monitored (blood pressure, heart rate, blood oxygen saturation (SpO2), and cardiotocography (CTG)) after entering the delivery room. Analgesia was administered in the left lateral decubitus position at the estimated level of the L2 to L3 interspace. The epidural space was identified using a loss-of-resistance approach with an 18-gauge Tuohy needle. An epidural catheter was inserted 3 cm cephaladly into the epidural space. After a negative cerebrospinal fluid and blood aspiration test, a test dose of 3 mL (1% lidocaine) was administered for 5 minutes. As the first epidural infusion dosage, Group S participants received 12 mL 0.4 µg/mL sufentanyl in combination with 0.1% ropivacaine, while Group D participants received 12 mL 0.4 µg/ml dexmedetomidine in combination with 0.1% ropivacaine. These mixed solutions were infused by a patient-controlled-analgesia pump (PCEA) when VAS ≥4. The PCEA pump was set to 8 mL/80 min with an 8 mL rescue bolus (lockout 30 minutes) (Group S: PCEA with ropivacaine (0.1%) + sufentanyl (0.4 µg/mL); Group D: PCEA with 0.1% ropivacaine + 0.4 µg/ml dexmedetomidine). Another anesthetist prepared local anesthetic solutions for epidural labor analgesia. The investigators were blind to these solutions.

AI Digest

Study Justification:

– The use of opioid analgesics during painless delivery can have negative side effects on both the mother and the baby, including respiratory depression and disruption of breathing and heart rate.
– Dexmedetomidine, a nonopioid analgesic, has shown to have higher selectivity, greater analgesic effects, and fewer side effects compared to opioids.
– Epidural administration of dexmedetomidine also reduces the consumption of local anesthetics.

Study Highlights:

– This study is a randomized, double-blinded, controlled trial involving 120 primiparous women who requested epidural labor analgesia.
– The participants were randomized to receive either ropivacaine with sufentanyl or dexmedetomidine as epidural labor analgesia.
– The primary outcomes measured included Visual Analogue Score (VAS), duration of first epidural infusions, the requirement of additional PCEA bolus, and adverse reactions during labor analgesia.
– The results showed that dexmedetomidine provided a longer duration of analgesic effect compared to sufentanyl, with fewer parturient women requiring additional PCEA bolus.
– The incidence of pruritus was also lower in the dexmedetomidine group compared to the sufentanyl group.

Recommendations for Lay Reader and Policy Maker:

– Dexmedetomidine, a nonopioid analgesic, is a superior option for epidural labor analgesia compared to sufentanyl, an opioid analgesic.
– Dexmedetomidine provides a prolonged analgesic effect, reduces the consumption of local anesthetics, and has fewer side effects.
– Policy makers should consider promoting the use of dexmedetomidine as an alternative to opioids for painless delivery to improve postpartum recovery and reduce the risk of respiratory depression and other adverse effects.

Key Role Players Needed to Address Recommendations:

– Anesthesiologists and healthcare providers involved in labor and delivery care
– Maternity hospitals and healthcare facilities
– Policy makers and regulatory bodies in the healthcare sector

Cost Items to Include in Planning the Recommendations:

– Research and development costs for further studies and trials on the use of dexmedetomidine in labor analgesia
– Training and education programs for healthcare providers on the administration and monitoring of dexmedetomidine
– Procurement and supply of dexmedetomidine and related equipment
– Implementation and monitoring costs for policy changes and guidelines related to the use of dexmedetomidine in labor analgesia

Strength of Evidence

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong because it is based on a randomized, double-blinded, controlled trial with a registration number. The study involved 120 participants and compared the analgesic effects and side effects of two different medications. The primary outcomes were measured, and the results showed significant differences between the groups. However, to improve the evidence, it would be helpful to provide more details about the methodology, such as the randomization process and blinding procedures. Additionally, including information about the statistical analysis performed and any potential limitations of the study would further strengthen the evidence.

Abstract

This study is a randomized, double-blinded, controlled clinical trial with registration no. ChiCTR2200055360 and is approved by the Inner Mongolia Baotou Maternity Hospital's Ethics Committee. Between January 2021 and August 2021, written informed permission was received from 120 study participants who requested epidural labor analgesia. Parturients were enrolled if they were considered as a physical status I or II (according to the American Society of Anesthesiologists), aged between 20 and 36 years, weighed less than 100 kg, carried a single fetus ≥38 weeks, and experienced cervical dilation ≥3 cm and ≤5 cm. The study exclusion criteria included patients with hypertensive disease, multiple gestations, and history of premature labors and patients with contraindications to epidural analgesia or allergies to opioids/local aesthetics, a history of chronic opioid analgesic use, and VAS ≥4 30 min after epidural labor analgesia. 120 patients were randomized in a balanced manner into two groups via a computer-generated random-number table: the sufentanyl group (Group S, n = 60) and the dexmedetomidine group (Group D, n = 60). All parturients who met the inclusion criteria were established with venous access and had their vital signs monitored (blood pressure, heart rate, blood oxygen saturation (SpO2), and cardiotocography (CTG)) after entering the delivery room. Analgesia was administered in the left lateral decubitus position at the estimated level of the L2 to L3 interspace. The epidural space was identified using a loss-of-resistance approach with an 18-gauge Tuohy needle. An epidural catheter was inserted 3 cm cephaladly into the epidural space. After a negative cerebrospinal fluid and blood aspiration test, a test dose of 3 mL (1% lidocaine) was administered for 5 minutes. As the first epidural infusion dosage, Group S participants received 12 mL 0.4 µg/mL sufentanyl in combination with 0.1% ropivacaine, while Group D participants received 12 mL 0.4 µg/ml dexmedetomidine in combination with 0.1% ropivacaine. These mixed solutions were infused by a patient-controlled-analgesia pump (PCEA) when VAS ≥4. The PCEA pump was set to 8 mL/80 min with an 8 mL rescue bolus (lockout 30 minutes) (Group S: PCEA with ropivacaine (0.1%) + sufentanyl (0.4 µg/mL); Group D: PCEA with 0.1% ropivacaine + 0.4 µg/ml dexmedetomidine). Another anesthetist prepared local anesthetic solutions for epidural labor analgesia. The investigators were blind to these solutions.

Materials

N/A

Innovations

The innovation described in the study is the use of dexmedetomidine, a nonopioid analgesic, as an adjuvant combined with ropivacaine for epidural labor analgesia. This innovation aims to improve access to maternal health by providing a safer and more effective alternative to opioid analgesics during painless delivery. Dexmedetomidine has higher selectivity, greater analgesic effects, and fewer side effects compared to opioids. It also reduces local anesthetic consumption and has a prolonged analgesic effect. The study is a randomized, double-blinded, controlled clinical trial that compares the analgesic effects and side effects of dexmedetomidine with sufentanyl. The trial is registered with ChiCTR2200055360 and has been approved by the Inner Mongolia Baotou Maternity Hospital’s Ethics Committee.

AI Innovations Description

The recommendation from this study is to use dexmedetomidine as an adjuvant combined with ropivacaine for opioid-free labor analgesia. This nonopioid analgesic has been found to have higher selectivity, greater analgesic effects, and fewer side effects compared to opioids. The study showed that dexmedetomidine provided a prolonged analgesic effect during labor, reduced the need for additional pain medication, and had a lower incidence of side effects such as pruritus. The study was a randomized, double-blinded, controlled trial involving 120 primiparous women who requested epidural labor analgesia. The participants were divided into two groups, one receiving sufentanyl and the other receiving dexmedetomidine in combination with ropivacaine. The results showed that dexmedetomidine was superior to sufentanyl in terms of analgesic effects and side effects. This recommendation can be used to develop an innovation in maternal health by implementing the use of dexmedetomidine as a safer and more effective alternative to opioids for pain management during labor.

AI Innovations Methodology

Based on the provided information, the study aims to compare the analgesic effects and side effects of using dexmedetomidine as an adjuvant combined with ropivacaine for labor analgesia, compared to using sufentanyl. Dexmedetomidine is a nonopioid analgesic that has shown to have higher selectivity, greater analgesic effects, and fewer side effects compared to opioids.

The methodology used in this study is a randomized, double-blinded, controlled trial. Here is a brief description of the methodology:

1. Study Participants: The study enrolled 120 primiparous (women who have given birth once), singleton pregnancy women who were greater than 38 weeks into gestation and had requested epidural labor analgesia. Participants were required to meet certain criteria, such as physical status I or II, aged between 20 and 36 years, weighing less than 100 kg, carrying a single fetus, and experiencing cervical dilation between 3 cm and 5 cm.

2. Randomization: The participants were randomly assigned to two groups: the sufentanyl group (Group S) and the dexmedetomidine group (Group D). The randomization was done using a computer-generated random-number table to ensure a balanced distribution of participants.

3. Administration of Analgesia: Analgesia was administered in the left lateral decubitus position at the estimated level of the L2 to L3 interspace. The epidural space was identified using a loss-of-resistance approach with an 18-gauge Tuohy needle. An epidural catheter was inserted, and after a negative cerebrospinal fluid and blood aspiration test, a test dose of lidocaine was administered. The first epidural infusion dosage for Group S was 12 mL of 0.4 μg/mL sufentanyl in combination with 0.1% ropivacaine, while Group D received 12 mL of 0.4 μg/mL dexmedetomidine in combination with 0.1% ropivacaine.

4. Monitoring and Data Collection: Vital signs of the participants, including blood pressure, heart rate, blood oxygen saturation, and cardiotocography, were monitored. The primary outcomes measured included Visual Analogue Score (VAS), duration of first epidural infusions, the requirement of additional PCEA (patient-controlled epidural analgesia) bolus, and adverse reactions during labor analgesia.

5. Data Analysis: The collected data from the study participants were analyzed to compare the outcomes between the two groups. Statistical analysis was performed to determine the significance of any differences observed.

In summary, the methodology used in this study involved randomizing participants into two groups, administering different analgesic combinations, monitoring vital signs, and collecting data on various outcomes. The data collected were then analyzed to compare the effectiveness and side effects of using dexmedetomidine as an adjuvant combined with ropivacaine for labor analgesia compared to using sufentanyl.

Author

Dima Health

Statistics:

Citations: 1

Identifiers:

DOI: 10.1155/2022/2235025

ISSN: 20402295

Research Areas:

Disability, Health System and Policy, Maternal and Child Health, Mental Health, Noncommunicable Diseases, Sexual and Reproductive Health, Substance Abuse

Study Design:

Cohort Study

Study Approach:

Qualitative

Participants Gender:

Female