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Completed

NCT Number: NCT03824314

Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section

The aim of this study is to compare the effects of intrathecal levobupivacaine plus midazolam and levobupivacaine plus fentanyl in patients undergoing caesarean section to get a prolonged postoperative analgesic effect and less side effects

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mohamed

Asyut, 71511, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients of American Society of Anaesthesiologists grades I and II ,

Exclusion criteria

  • pre-existing neurological or spinal disease

Treatment and study plan

midazolam

Drug

2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg)will be given intrathecally in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position

Fentanyl

Drug

2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml fentanyl (25 μg)will be given intrathecally in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position

Primary outcomes

  1. 1st post-operative analgesic request

    Time frame: 24-hour

    pain will be evaluated using VAS score, every 30 min for 180 min then hourly for 12 h and thereafter every 3 hourly till 24 h of surgery in both groups. Rescue analgesia in the form of injection Ketorolac 30mg I.V when VAS >3 in both groups.

Secondary outcomes

  1. duration of sensory block Total analgesic consumption

    Time frame: 24-hour

    total duration of sensory block (regression to S1 dermatome) will be noted

Sponsors and collaborators

Lead sponsor

Mohamed Abdelrady Mohamed

Other

Registry information

Official study title

Comparison of the Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2019
Registry last updated
Jul 14, 2020

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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