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Dexmedetomidine Wound Infiltration in Cesarean Section

ConditionPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAttikon Hospital

About this trial

The effects of four different wound infiltration protocols in cesarean section will be investigated on parturient' pain intensity, PCA morphine consumption given, side effects and parturient' overall satisfaction.

One group will receive for wound infiltration dexmedetomidine, the second ropivacaine, the third dexmedetomidine combined with ropivacaine, while the last one will receive normal saline (placebo group).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

pregnancy >37 weeks, ASA I-II, BMI<35

Disqualifiers

patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, presence of atrioventricular block, severe systemic disease, multiple gestation, high risk pregnancy, contraindications to epidural technique, a history of severe systemic disease, recreational drug or alcohol use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    WOUND INFILTRATION IN CESAREAN SECTION

  • Ropivacaine

    Drug

    WOUND INFILTRATION IN CESAREAN SECTION

  • Dexmedetomidine - Ropivacaine

    Drug

    WOUND INFILTRATION IN CESAREAN SECTION

  • 0,9% saline

    Other intervention

    placebo WOUND INFILTRATION IN CESAREAN SECTION

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: DexmedetomidineActive comparator 1 intervention
Group B: RopivacaineActive comparator 1 intervention
Group C: Dexmedetomidine - RopivacaineActive comparator 1 intervention
Group D: 0.9 % salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain score

Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)

Time frame
up to 24 hours after the end of surgery

Secondary outcomes

1

morphine consumption

morphine given by PCA (1 mg/ml)(setting: bolus dose 1 ml every 7 min).

Time frame
24 hours after the PCA device initiation will be recorded
2

overall patient satisfaction

overall patient satisfaction with postoperative analgesia using a 4 point scale

Time frame
24 hours after the end of surgery

Other outcomes

Sponsors and contacts

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

Attikon Hospital

Lead sponsor

Source ClinicalTrials.gov
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