Dexmedetomidine vs Fentanyl in Controlling Labor Pain

NCT06392321 | Completed

• 1 other identifier: controlling labor pain
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

As most woman experience agonizing pain throughout vaginal labor. Adjuvants were added to intrathecal bupivacaine aiming to improve the quality of analgesia. This study aimed to assess the efficacy and outcome of intrathecal dexmedetomidine and fentanyl in controlling pain during delivery.

Conditions

Labor Pain

Keywords

Dexmedetomidine; Fentanyl; intrathecal; labor pain

Outcome Measures

Primary Outcomes (1)

• efficacy of intrathecal dexmedetomidine

  VAS

  120 minutes

Secondary Outcomes (2)

• patient satisfaction

  2 hours

• mother's outocme

  1 and 5 minutes

Study Arms (3)

Fentanyl

ACTIVE COMPARATOR

Bupivacaine 3,75 mg + 2.5 ml saline added to fentanyl 20 microgram + 2.3 ml saline

Drug: Fentanyl

Dexmedetomidine

ACTIVE COMPARATOR

Bupivacaine 3,75 mg + 2.5 ml saline added to dexmedetomedine 5 microgram + 2.3 ml saline

Drug: Dexmedetomidine

control

NO INTERVENTION

Bupivacaine 3,75 mg + 2.5 ml saline

Interventions

Fentanyl DRUG

comparison between bupivacaine, bupivacaine and fentanyl.

Fentanyl

Dexmedetomidine DRUG

comparison between bupivacaine, bupivacaine and dexmedetomidine..

Dexmedetomidine

Eligibility Criteria

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

You may qualify if:

• women planned for spontaneous vaginal delivery.

You may not qualify if:

• cardiac, liver or kidney disease, allergy to local anesthetics or the studied drugs, any contraindication of regional anesthesia and intrauterine growth retardation or fetal compromise.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Naser City, 11811, Egypt

Location

Related Publications (4)

• Lupu VV, Miron IC, Raileanu AA, Starcea IM, Lupu A, Tarca E, Mocanu A, Buga AML, Lupu V, Fotea S. Difficulties in Adaptation of the Mother and Newborn via Cesarean Section versus Natural Birth-A Narrative Review. Life (Basel). 2023 Jan 21;13(2):300. doi: 10.3390/life13020300.

  PMID: 36836657 BACKGROUND

• Parikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.

  PMID: 30237594 BACKGROUND

• Shrestha IK, Chalise R, Poudel S, Regmi A, Ghimire A, Khadka B, Khanal K. Neostigmine and atropine as a treatment for postdural puncture headache after spinal anesthesia in cesarean section: A case report. Clin Case Rep. 2023 Nov 2;11(11):e8132. doi: 10.1002/ccr3.8132. eCollection 2023 Nov.

  PMID: 37927977 BACKGROUND

• Show KL, Ngamjarus C, Kongwattanakul K, Rattanakanokchai S, Duangkum C, Bohren MA, Betran AP, Somjit M, Win WYH, Lumbiganon P. Fentanyl for labour pain management: a scoping review. BMC Pregnancy Childbirth. 2022 Nov 17;22(1):846. doi: 10.1186/s12884-022-05169-x.

  PMID: 36397024 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Fentanyl; Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)