Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

A

Ain Shams University

Status and phase

Completed
Phase 2

Conditions

Labor Pain
Epidural Anesthesia

Treatments

Drug: Dexmedetomidine
Drug: Nalbuphine

Study type

Interventional

Funder types

Other

Identifiers

NCT05327088
Epidural analgesia

Details and patient eligibility

About

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.

Full description

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.

Enrollment

64 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All the parturients should :

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

Exclusion criteria

Parturients

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Group A (Dexmedetomidine group)
Active Comparator group
Description:
a bolus dose of 11ml of 0.25% bupivacaine + 0.5μg/ml preservative free dexmedetomidine (1ml volume) will be injected via the epidural catheter. For top up 5 ml of 0.25% bupivacaine + 0.5μg/ml dexmedetomidine (1ml volume) will be given when VAS score becomes 4 or more.
Treatment:
Drug: Dexmedetomidine
Group B (Nalbuphine group)
Active Comparator group
Description:
a bolus dose of 11ml of 0.25% bupivacaine + 10mg preservative free nalbuphine (1ml volume) will be injected via the epidural catheter. For top up 5 ml of 0.25% bupivacaine + 2mg nalbuphine (1ml volume) will be given when VAS score becomes 4 or more.
Treatment:
Drug: Nalbuphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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