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Completed

NCT Number: NCT06392321

Dexmedetomidine vs Fentanyl in Controlling Labor Pain

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al Azhar University

Cairo, Naser City, 11811, Egypt

About this study

Throughout vaginal deliveries, many women suffered from pain. providing suitable analgesia is crucial (Lupu et al., 2023). Spinal anesthesia can provide pain management (Parikh et al., 2018).

Various types of analgesics can be combined to get the needed duration of perioperative analgesia. Dexmedetomidine has been used with effective pain management outcomes (Shrestha et al., 2023). Fentanyl can help pain relief in short duration procedures (Show et al., 2022).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women planned for spontaneous vaginal delivery.

Exclusion criteria

  • 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.

Treatment and study plan

Fentanyl

Drug

comparison between bupivacaine, bupivacaine and fentanyl.

Dexmedetomidine

Drug

comparison between bupivacaine, bupivacaine and dexmedetomidine..

Primary outcomes

  1. efficacy of intrathecal dexmedetomidine

    Time frame: 120 minutes

    VAS

Secondary outcomes

  1. patient satisfaction

    Time frame: 2 hours

    satisfaction score

  2. mother's outocme

    Time frame: 1 and 5 minutes

    APGAR

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Dexmedetomidine Versus Fentanyl as an Adjuvant to Single Low Dose Spinal Anesthesia in Controlling Labor Pain: a Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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