Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

Labor Pain Clinical Trial

Official title:

Effect of Epidural Dexmedetomidine VS Nalbuphine for Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327088
• Other study ID #: Epidural analgesia
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2021
• Est. completion date: March 12, 2022

Study information

• Verified date: April 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 12, 2022
• Est. primary completion date: February 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Anesthesia
• Labor Pain

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine, a highly selective a2 receptor agonist, has a sympatholytic, sedative and opioid sparing effect.
• Nalbuphine
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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View 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. Review. French. — View 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. — View 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. — View 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). pii: E2792. doi: 10.3390/ijerph15122792. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in VAS score for pain before analgesia and every 30 minutes after analgesia	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.	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	change in Heart rate before analgesia and every 30 minutes after analgesia	Monitored and recorded	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	change in arterial blood pressure before analgesia and every 30 minutes after analgesia	Monitored and recorded	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	change in SpO2 before analgesia and every 30 minutes after analgesia	Monitored and recorded	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	Duration of active phase of 1st stage of labor	The duration of active phase of 1st stage of labor varies from one to the other	from 100 minutes to 300 minutes
Secondary	Duration of 2nd stage of labor	The duration of 2nd stage of labor varies from one to the other	from 30 minutes to 200 minutes
Secondary	Duration of 3rd stage of labor	The duration of 3rd stage of labor varies from one to the other	from 5 minutes to 15 minutes
Secondary	Neonatal condition: APGAR score at 1 and 5 min after the birth	to check if any of the study drugs can deteriorate the neonatal condition	At 1 minute and 5 minutes after birth
Secondary	The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension	These adverse reaction can occur after administration of the interventional drugs	As long as the epidural catheter is inserted (up to 360 minutes)