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Epidural AnesthesiaPhase 2NCT05327088

Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

A Phase 2 study testing Dexmedetomidine and Nalbuphine in people with Epidural Anesthesia and Labor Pain, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 40 years, women only
Conditions the study is for
Epidural Anesthesia, Labor Pain
What is being tested?
Dexmedetomidine and Nalbuphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteEgypt
Study dates
12 Sep 2021to 12 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Ain Shams University

    Cairo

Other trials in Egypt

About this study

Official title: Effect of Epidural Dexmedetomidine VS Nalbuphine for Labor Analgesia

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.

Read the 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.

Being tested
Dexmedetomidine, Nalbuphine
Keywords
Dexmedetomidine, Nalbuphine
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex

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

  • NalbuphineDrug

    Also called Nalufin

    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

Study groups in NCT05327088
Study groupRoleWhat they receive
Group A (Dexmedetomidine group)Active comparatora 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.
Receives: Drug: Dexmedetomidine
Group B (Nalbuphine group)Active comparatora 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.
Receives: Drug: Nalbuphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. change in Heart rate before analgesia and every 30 minutes after analgesia

    Monitored and recorded

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

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

    Monitored and recorded

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

  3. change in SpO2 before analgesia and every 30 minutes after analgesia

    Monitored and recorded

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

  4. 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

    Measured: from 100 minutes to 300 minutes

  5. Duration of 2nd stage of labor

    The duration of 2nd stage of labor varies from one to the other

    Measured: from 30 minutes to 200 minutes

  6. Duration of 3rd stage of labor

    The duration of 3rd stage of labor varies from one to the other

    Measured: from 5 minutes to 15 minutes

  7. 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

    Measured: At 1 minute and 5 minutes after birth

  8. The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension

    These adverse reaction can occur after administration of the interventional drugs

    Measured: As long as the epidural catheter is inserted (up to 360 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start12 Sep 2021
  3. Primary completion12 Feb 2022
  4. Study completion12 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05327088
Sponsor's protocol ID
Epidural analgesia
Status last verified
Apr 2022
First submitted
28 Mar 2022
Last updated
14 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26543463

  • 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.

    PubMed 1914055

  • 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.

    PubMed 26712968

  • 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.

    PubMed 30544878

  • 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.

    PubMed 11419241

  • 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.

    PubMed 34745286

  • 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.

    PubMed 28656055

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexmedetomidine and Nalbuphine in people with Epidural Anesthesia and Labor Pain, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in VAS score for pain before analgesia and every 30 minutes after analgesia (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05327088, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.

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