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Completed

NCT Number: NCT05327088

Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

The aim of this study is to compare epidural dexmedetomidine vs nalbuphine added to bupivacaine in labor analgesia and determine the privilege of one over the other and to compare the effect of both analgesics after delivery.

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Key information

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University

Cairo, Egypt

About this study

Labor pain often causes a strong stress response in women. Recently, it is concerned by most mothers and doctors that how to effectively alleviate the pain during delivery. There is no standard treatment for labor pain. A wide range of pharmacological and non-pharmacological labor pain relief techniques are available for pregnant women . Labor analgesia, also known as painless childbirth, refers to the use of various methods to reduce maternal labor pain or make it disappear. The ideal labor analgesia should be based on maternal and child safety, and should have fast acting, good analgesic effect and less adverse reaction. Epidural block anesthesia is convenient, and has less adverse reaction and obvious effect in the commonly used analgesic methods, which is widely used in the current way of analgesia. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that has sedative, hypnotic, and analgesic effects . Nalbuphine is a synthetic agonist antagoLabor pain often causes a strong stress response in women. Recently, it is concerned by most mothers and doctors that how to effectively alleviate the pain during delivery. There is no standard treatment for labor pain. A wide range of pharmacological and non-pharmacological labor pain relief techniques are available for pregnant women . Labor analgesia, also known as painless childbirth, refers to the use of various methods to reduce maternal labor pain or make it disappear. The ideal labor analgesia should be based on maternal and child safety, and should have fast acting, good analgesic effect and less adverse reaction. Epidural block anesthesia is convenient, and has less adverse reaction and obvious effect in the commonly used analgesic methods, which is widely used in the current way of analgesia. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that has sedative, hypnotic, and analgesic effects . Nalbuphine is a synthetic agonist antagonist opioid that has the characteristics of mu-antagonist and kappa-agonist activities. Nalbuphine has gained popularity as a parenteral analgesic for intraoperative, postoperative, and obstetrical uses . The purpose of this study is to compare between the 2 drugs in decreasing labor pain. st opioid that has the characteristics of mu-antagonist and kappa-agonist activities. Nalbuphine has gained popularity as a parenteral analgesic for intraoperative, postoperative, and obstetrical uses . The purpose of this study is to compare between the 2 drugs in decreasing labor pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All the parturients should :

  • Be between 21 - 40 years old
  • ASA classification I- II
  • Para 1-2
  • Requesting analgesia
  • Have a normal birth canal
  • Be at the beginning of active phase of labor i.e. cervical dilatation of 4 cm with regular uterine contractions.
  • The fetus should be a single full-term fetus (37- 42 weeks of gestation) with normal head position, normal development.

Exclusion criteria

Parturients

  • Younger than 21 and older than 40 years old
  • With contraindication of regional anesthesia
  • With pre-existing neurological disease
  • With history of allergy to the study drugs
  • With cephalopelvic disproportion, fetal distress, amniotic fluid infection, placental insufficiency or scarred uterus

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine, a highly selective α₂ receptor agonist, has a sympatholytic, sedative and opioid sparing effect.

Other names: Precedex

Nalbuphine

Drug

Nalbuphine, a derivative of 14-hydroxymorphine is a strong analgesic with mixed k agonist and µ antagonist properties. The analgesic potency of nalbuphine has been found to be equal to morphine

Other names: Nalufin

Primary outcomes

  1. change in VAS score for pain before analgesia and every 30 minutes after analgesia

    Time frame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)

    The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a 100 mm (10 cm) horizontal line, and this rating is then measured from the left edge (=VAS score). The VAS score correlates well with acute pain levels (Myles et al., 1999). Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the no pain anchor and the patients mark, providing a range of scores from 010. A higher score indicates greater pain intensity.

Secondary outcomes

  1. change in Heart rate before analgesia and every 30 minutes after analgesia

    Time frame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)

    Monitored and recorded

  2. change in arterial blood pressure before analgesia and every 30 minutes after analgesia

    Time frame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)

    Monitored and recorded

  3. change in SpO2 before analgesia and every 30 minutes after analgesia

    Time frame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)

    Monitored and recorded

  4. Duration of active phase of 1st stage of labor

    Time frame: from 100 minutes to 300 minutes

    The duration of active phase of 1st stage of labor varies from one to the other

  5. Duration of 2nd stage of labor

    Time frame: from 30 minutes to 200 minutes

    The duration of 2nd stage of labor varies from one to the other

  6. Duration of 3rd stage of labor

    Time frame: from 5 minutes to 15 minutes

    The duration of 3rd stage of labor varies from one to the other

  7. Neonatal condition: APGAR score at 1 and 5 min after the birth

    Time frame: At 1 minute and 5 minutes after birth

    to check if any of the study drugs can deteriorate the neonatal condition

  8. The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension

    Time frame: As long as the epidural catheter is inserted (up to 360 minutes)

    These adverse reaction can occur after administration of the interventional drugs

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Epidural Dexmedetomidine VS Nalbuphine for Labor Analgesia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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