Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

NCT05327088 | Completed Phase 2

• 1 other identifier: Epidural analgesia
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidural Anesthesia; Labor Pain

Keywords

Dexmedetomidine; Nalbuphine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• change in Heart rate before analgesia and every 30 minutes after analgesia

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

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

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

• change in SpO2 before analgesia and every 30 minutes after analgesia

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

• Duration of active phase of 1st stage of labor

  from 100 minutes to 300 minutes

• Duration of 2nd stage of labor

  from 30 minutes to 200 minutes

Study Arms (2)

Group A (Dexmedetomidine group)

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine

Group B (Nalbuphine group)

ACTIVE COMPARATOR

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.

Drug: Nalbuphine

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Group A (Dexmedetomidine group)

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

Also known as: Nalufin

Group B (Nalbuphine group)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related 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.

  PMID: 26543463 BACKGROUND

• 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.

  PMID: 1914055 BACKGROUND

• 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.

  PMID: 26712968 BACKGROUND

• 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.

  PMID: 30544878 BACKGROUND

• 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.

  PMID: 11419241 BACKGROUND

• 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.

  PMID: 34745286 BACKGROUND

• 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.

  PMID: 28656055 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Dexmedetomidine; Nalbuphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 14, 2022
• Study Start: September 12, 2021
• Primary Completion: February 12, 2022
• Study Completion: March 12, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

EG (1)