Dexmedetomidine for Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia

NCT05781854 | Recruiting Phase 2

• 1 other identifier: Dexmedetomidine in normallabor
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare two modes of labour epidural analgesia: programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI), with patient controlled epidural analgesia (PCEA), using dexmedetomidine in addition to low-dose bupivacaine and through measuring the total volume of local anesthetic received through patient controlled epidural analgesia per hour

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• total volume of local anesthetic

  total volume of local anesthetic received through patient controlled epidural analgesia per hour

  24 hour

Secondary Outcomes (5)

• Ramsay sedation scale

  24 hour

• Heart rate

  24 hour

• Blood Pressure

  24 hour

• Likert scale for satisfaction

  24 hour

• Bromage score for motor block

  24 hour

Study Arms (2)

Group P (PIEB-group)

ACTIVE COMPARATOR

After the initial epidural loading dose of 10 ml, 30 patients will receive programmed intermittent epidural boluses (5 ml every 45 min with the first bolus 30 minutes after epidural initiation) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).

Drug: Epidural analgesia with bupivacaine and dexmedetomidine

Group C (CEI-group)

ACTIVE COMPARATOR

After the initial epidural loading dose of 10 ml, 30 patients will receive continuous epidural infusion (5 ml/h starting immediately after the loading dose) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period).

Drug: Epidural analgesia with bupivacaine and dexmedetomidine

Interventions

Epidural analgesia with bupivacaine and dexmedetomidine DRUG

Epidural analgesia with bupivacaine and dexmedetomidine

Group C (CEI-group); Group P (PIEB-group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 45 years
• Scheduled for normal vaginal delivery
• ASA physical status ӀI-IӀӀ.
• Singleton non-complicated pregnancy.
• At least 36 weak of gestation.
• Vertex presentation.

You may not qualify if:

• Patient refusal to epidural analgesia.
• History of cardiac, liver, or kidney diseases.
• History of allergy to amide local anesthetics or study medications.
• Any neurological problem.
• History of chronic opioid analgesic use.
• Any contraindication of regional anesthesia.
• Evidence of intrauterine growth restriction or fetal compromise.
• Failed or unsatisfactory analgesic block.
• Body mass index ≥40 kg/m2

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71111, Egypt

RECRUITING

Related Publications (13)

• Ebirim, L.N., Buowari, O.Y., Ghosh, S. Physical and Psychological Aspects of Pain in Obstetrics. In: Ghosh, S., editor. Pain in Perspective [Internet]. London: IntechOpen; 2012 [cited 2022 Oct 18]. Available from: https://www.intechopen.com/chapters/40395 doi: 10.5772/53923

  BACKGROUND

• Fortescue C, Wee MYK. Analgesia in labour: non-regional techniques. Continuing Education in Anaesthesia, Critical Care, and Pain. 2005; 5(1): 219-223.

  BACKGROUND

• Paramasivan A, Lopez-Olivo MA, Foong TW, Tan YW, Yap APA. Intrathecal dexmedetomidine and postoperative pain: A systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020 Aug;24(7):1215-1227. doi: 10.1002/ejp.1575. Epub 2020 May 22.

  PMID: 32333825 BACKGROUND

• Verghese T, Dixit N, John L, et al. Effect of intravenous dexmedetomidine on duration of spinal anaesthesia with hyperbaric bupivacaine - A comparative study. Indian J Clin Anaesth. 2019;6(1):97-101

  BACKGROUND

• Mostafa MF, Herdan R, Fathy GM, Hassan ZEAZ, Galal H, Talaat A, Ibrahim AK. Intrathecal dexmedetomidine versus magnesium sulphate for postoperative analgesia and stress response after caesarean delivery; randomized controlled double-blind study. Eur J Pain. 2020 Jan;24(1):182-191. doi: 10.1002/ejp.1476. Epub 2019 Sep 12.

  PMID: 31461801 BACKGROUND

• Martin E, Ramsay G, Mantz J, Sum-Ping ST. The role of the alpha2-adrenoceptor agonist dexmedetomidine in postsurgical sedation in the intensive care unit. J Intensive Care Med. 2003 Jan-Feb;18(1):29-41. doi: 10.1177/0885066602239122.

  PMID: 15189665 BACKGROUND

• Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.

  PMID: 16369581 BACKGROUND

• Werdehausen R, Fazeli S, Braun S, Hermanns H, Essmann F, Hollmann MW, Bauer I, Stevens MF. Apoptosis induction by different local anaesthetics in a neuroblastoma cell line. Br J Anaesth. 2009 Nov;103(5):711-8. doi: 10.1093/bja/aep236. Epub 2009 Aug 22.

  PMID: 19700777 BACKGROUND

• Fairbanks CA, Wilcox GL. Spinal antinociceptive synergism between morphine and clonidine persists in mice made acutely or chronically tolerant to morphine. J Pharmacol Exp Ther. 1999 Mar;288(3):1107-16.

  PMID: 10027848 BACKGROUND

• Sng BL, Sia ATH. Maintenance of epidural labour analgesia: The old, the new and the future. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):15-22. doi: 10.1016/j.bpa.2017.01.002. Epub 2017 Jan 12.

  PMID: 28625301 BACKGROUND

• Ojo OA, Mehdiratta JE, Gamez BH, Hunting J, Habib AS. Comparison of Programmed Intermittent Epidural Boluses With Continuous Epidural Infusion for the Maintenance of Labor Analgesia: A Randomized, Controlled, Double-Blind Study. Anesth Analg. 2020 Feb;130(2):426-435. doi: 10.1213/ANE.0000000000004104.

  PMID: 30882524 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• El Fawal, S., El Kabarity, R., Ahmed, N., Abd-El-Tawab, S. (2022). Effect of Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia. A randomized clinical trial. Egyptian J Anesthesia: 38 (1); 373382

  BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Analgesia, Epidural; Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zein El-Abden Zareh Hassan, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Hassan Khaled Ahmed Gomaa, Resident

CONTACT

01067319365; hassssan.khaled2013@gmail.com

Mohamed Fathy Mostafa, Ass. Prof.

CONTACT

01001123062; mo7_fathy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator , anesthesiology and ICU resident

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 23, 2023
• Study Start: May 29, 2023
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

EG (1)