Spinal Analgesia in Labour Pain

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMinia University Hospital

About this trial

To evaluate the efficacy and safety of dexmedetomidine as an adjuvant to bupivacain and fentanyl in spinal Analgesia to decreases pain during normal labour

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • injecting dexmedetomidine

    Drug

    injecting dexmedetomidine intrathecally during labour pain

  • injecting mixture of bupivacaine fentanyl

    Drug

    injecting mixture of bupivacaine fentanyl intrathecally

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: DEXActive comparator 1 intervention
Group B: CONTROLLEDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0

evaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain )

Time frame
baseline
2

duration of sensory blockade

change in numeric pain intensity score ( NPIS )

Time frame
5 minutes after injection of analgesic agents till normal delivery done
3

changes in numeric pain intensity score ( NPIS )

Scores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain

Time frame
5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents

Secondary outcomes

Other outcomes

Sponsors and contacts

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