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Transversalis Fascia Plane Block Versus Intrathecal Dexmedetomidine in Patients Undergoing Cesarean Section

ConditionsTransversalis Fascia Plane BlockIntrathecal DexmedetomidineCesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorTanta University

About this trial

This study aims to compare the analgesic efficacy of the transversalis fascia plane (TFP) block and intrathecal dexmedetomidine in patients undergoing cesarean section (CS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 40 years.

American Society of Anesthesiology (ASA) physical status II.

Women undergoing cesarean section under spinal anesthesia.

Disqualifiers

Contraindication to spinal anesthesia.

Women with body mass index >40 kg/m2.

Pregnancy-induced hypertension

Local infection at the site of injection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transversalis fascia plane block

    Other intervention

    Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.

  • Intrathecal dexmedetomidine

    Drug

    Patients will receive spinal anesthesia (using 2.5 mL of hyperbaric bupivacaine 0.5%) + (5 µg intrathecal dexmedetomidine diluted in 0.5ml saline) with a sham block at the end of surgery.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: TFP groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Degree of pain

Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, 18 and 24 h postoperatively.

Time frame
24 hours postoperatively

Secondary outcomes

1

Total morphine consumption

Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4.

Time frame
24 hours postoperatively
2

Time to the 1st rescue analgesia

Time to the first request for the rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated.

Time frame
24 hours postoperatively
3

Mean arterial pressure

Mean arterial pressure will be recorded preoperatively and every 30 minutes till the end of surgery.

Time frame
Till the end of surgery (Up to 2 hours)
4

Heart rate

Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.

Time frame
Till the end of surgery (Up to 2 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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