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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.
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 ฮฑ2 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 ฮฑ2 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Dexmedetomidine group) | Active Comparator | a bolus dose of 11ml of 0.25% bupivacaine + 0.5ฮผg/ml preservative free dexmedetomidine (1ml volume) will be injected via the epidural catheter. For top up 5 ml of 0.25% bupivacaine + 0.5ฮผg/ml dexmedetomidine (1ml volume) will be given when VAS score becomes 4 or more. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine, a highly selective ฮฑโ receptor agonist, has a sympatholytic, sedative and opioid sparing effect. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| change in arterial blood pressure before analgesia and every 30 minutes after analgesia |
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Inclusion Criteria:
All the parturients should :
Exclusion Criteria:
Parturients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26543463 | Background | 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. | |
| 1914055 | 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. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Nalbuphine | Drug | Nalbuphine, a derivative of 14-hydroxymorphine is a strong analgesic with mixed k agonist and ยต antagonist properties. The analgesic potency of nalbuphine has been found to be equal to morphine |
|
|
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) |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 26712968 | 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. |
| 30544878 | 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. |
| 11419241 | 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. |
| 34745286 | 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. |
| 28656055 | 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. |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |