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Dexmedetomidine Versus Fentanyl as Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: A Randomized Clinical Trial

ConditionNephrectomy
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

The aim of this clinical trial is to compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .

• Secondary outcome Pain scores; Numerical Rating Scale (NRS) at rest and when coughing \[at 1, 2, 4, 8, 16 and 24 hours postoperatively.\] The total opiod dose in the first 24 hours postoperatively. Duration of analgesia is defined as duration between block administration and time of first analgesic request.

Any adverse effects related to anesthesia or the technique. Incidence of Postoperative nausea \& vomiting . Block related complication during and after block procedure till 24hours postoperatively (local anesthetic systemic toxicity, pneumothorax and vascular puncture during block procedure).

Intraoperative haemodynamics parameters MAP ,HR , co2 and SP O2 . Postoperative haemodynamics parameters MAP , HR and SP O2 \[at 1, 2, 4, 8, 16 and 24 hours postoperatively. \]

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years old Both sex patients who are American society of Anesthesiologists class I or

Disqualifiers

Patient's refusal.

body mass index (BMI) ≥40 kg/m2.

Local infection at site of block.

Spine deformities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector Spinae Plane Block

    Procedure/Surgery

    Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.

  • Dexmedetomidine

    Drug

    50 mic dexmedetomidine which is diluted to 2ml.

  • fentanyl

    Drug

    100 mic fentanylwhich is also diluted to 2 ml.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Group dexmedetomidineActive comparator 0 interventions
Group B: Group fentanylActive comparator 0 interventions

Trial outcomes

Primary outcomes

1

the time to first analgesic request

To compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .

Time frame
24 hours

Secondary outcomes

1

Pain scores

Numerical Rating Scale (NRS) when coughing

Time frame
24 hours
2

The total opiod dose

The total opiod dose postoperatively

Time frame
24 hours
3

Duration of analgesia

Duration of analgesia is defined as duration between block administration and time of first analgesic request.

Time frame
24 hours
4

Postoperative nausea & vomiting

Incidence of Postoperative nausea \& vomiting

Time frame
24 hours

Other outcomes

Sponsors and contacts

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

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: