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Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

Primary Purpose

Epidural Anesthesia, Labor Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Nalbuphine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidural Anesthesia focused on measuring Dexmedetomidine, Nalbuphine

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A (Dexmedetomidine group)

Group B (Nalbuphine group)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in Heart rate before analgesia and every 30 minutes after analgesia
Monitored and recorded
change in arterial blood pressure before analgesia and every 30 minutes after analgesia
Monitored and recorded
change in SpO2 before analgesia and every 30 minutes after analgesia
Monitored and recorded
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
Duration of 2nd stage of labor
The duration of 2nd stage of labor varies from one to the other
Duration of 3rd stage of labor
The duration of 3rd stage of labor varies from one to the other
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
The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension
These adverse reaction can occur after administration of the interventional drugs

Full Information

First Posted
March 28, 2022
Last Updated
April 12, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05327088
Brief Title
Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia
Official Title
Effect of Epidural Dexmedetomidine VS Nalbuphine for Labor Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 12, 2021 (Actual)
Primary Completion Date
February 12, 2022 (Actual)
Study Completion Date
March 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural Anesthesia, Labor Pain
Keywords
Dexmedetomidine, Nalbuphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Dexmedetomidine group)
Arm Type
Active Comparator
Arm 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.
Arm Title
Group B (Nalbuphine group)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine, a highly selective α₂ receptor agonist, has a sympatholytic, sedative and opioid sparing effect.
Intervention Type
Drug
Intervention Name(s)
Nalbuphine
Other Intervention Name(s)
Nalufin
Intervention Description
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
Primary Outcome Measure Information:
Title
change in VAS score for pain before analgesia and every 30 minutes after analgesia
Description
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.
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)
Secondary Outcome Measure Information:
Title
change in Heart rate before analgesia and every 30 minutes after analgesia
Description
Monitored and recorded
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)
Title
change in arterial blood pressure before analgesia and every 30 minutes after analgesia
Description
Monitored and recorded
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)
Title
change in SpO2 before analgesia and every 30 minutes after analgesia
Description
Monitored and recorded
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)
Title
Duration of active phase of 1st stage of labor
Description
The duration of active phase of 1st stage of labor varies from one to the other
Time Frame
from 100 minutes to 300 minutes
Title
Duration of 2nd stage of labor
Description
The duration of 2nd stage of labor varies from one to the other
Time Frame
from 30 minutes to 200 minutes
Title
Duration of 3rd stage of labor
Description
The duration of 3rd stage of labor varies from one to the other
Time Frame
from 5 minutes to 15 minutes
Title
Neonatal condition: APGAR score at 1 and 5 min after the birth
Description
to check if any of the study drugs can deteriorate the neonatal condition
Time Frame
At 1 minute and 5 minutes after birth
Title
The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension
Description
These adverse reaction can occur after administration of the interventional drugs
Time Frame
As long as the epidural catheter is inserted (up to 360 minutes)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
26543463
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.
Results Reference
background
PubMed Identifier
1914055
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.
Results Reference
background
PubMed Identifier
26712968
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.
Results Reference
background
PubMed Identifier
30544878
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.
Results Reference
background
PubMed Identifier
11419241
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.
Results Reference
background
PubMed Identifier
34745286
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.
Results Reference
background
PubMed Identifier
28656055
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.
Results Reference
background

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Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

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