Clinical trial NCT05327088: Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia
Official title: Effect of Epidural Dexmedetomidine VS Nalbuphine for Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epidural Anesthesia
Labor Pain
Keywords: Dexmedetomidine
Nalbuphine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 64
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in VAS score for pain before analgesia and every 30 minutes after analgesia
timeFrame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)
Secondary outcomes:
measure: change in Heart rate before analgesia and every 30 minutes after analgesia
timeFrame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)
measure: change in arterial blood pressure before analgesia and every 30 minutes after analgesia
timeFrame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)
measure: change in SpO2 before analgesia and every 30 minutes after analgesia
timeFrame: before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes)
measure: Duration of active phase of 1st stage of labor
timeFrame: from 100 minutes to 300 minutes
measure: Duration of 2nd stage of labor
timeFrame: from 30 minutes to 200 minutes
measure: Duration of 3rd stage of labor
timeFrame: from 5 minutes to 15 minutes
measure: Neonatal condition: APGAR score at 1 and 5 min after the birth
timeFrame: At 1 minute and 5 minutes after birth
measure: The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension
timeFrame: As long as the epidural catheter is inserted (up to 360 minutes)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
citation: Abdalla W, Ammar MA, Tharwat AI. Combination of dexmedetomidine and remifentanil for labor analgesia: A double-blinded, randomized, controlled study. Saudi J Anaesth. 2015 Oct-Dec;9(4):433-8. doi: 10.4103/1658-354X.159470.
citation: Camann WR, Hurley RH, Gilbertson LI, Long ML, Datta S. Epidural nalbuphine for analgesia following caesarean delivery: dose-response and effect of local anaesthetic choice. Can J Anaesth. 1991 Sep;38(6):728-32. doi: 10.1007/BF03008450.
citation: Chatrath V, Attri JP, Bala A, Khetarpal R, Ahuja D, Kaur S. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015 Sep-Dec;9(3):326-30. doi: 10.4103/0259-1162.158004.
citation: Czech I, Fuchs P, Fuchs A, Lorek M, Tobolska-Lorek D, Drosdzol-Cop A, Sikora J. Pharmacological and Non-Pharmacological Methods of Labour Pain Relief-Establishment of Effectiveness and Comparison. Int J Environ Res Public Health. 2018 Dec 9;15(12):2792. doi: 10.3390/ijerph15122792.
citation: Aveline C, Bonnet F. [The effects of peridural anesthesia on duration of labor and mode of delivery]. Ann Fr Anesth Reanim. 2001 May;20(5):471-84. doi: 10.1016/s0750-7658(01)00398-7. French.
citation: Li N, Hu L, Li C, Pan X, Tang Y. Effect of Epidural Dexmedetomidine as an Adjuvant to Local Anesthetics for Labor Analgesia: A Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2021 Oct 27;2021:4886970. doi: 10.1155/2021/4886970. eCollection 2021.
citation: Wangping Z, Ming R. Optimal Dose of Epidural Dexmedetomidine Added to Ropivacaine for Epidural Labor Analgesia: A Pilot Study. Evid Based Complement Alternat Med. 2017;2017:7924148. doi: 10.1155/2017/7924148. Epub 2017 Jun 1.