Assiut University
Asyut, Asyut Governorate, Egypt
NCT Number: NCT06799442
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. ]
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Asyut, Asyut Governorate, Egypt
An independent anesthesiologist randomly divided the patients into 2 groups of 23 patients each using computer-generated random numbers dexmedetomidine group and fentanyl group (Group D and Group F). We discreetly placed the randomization results in envelopes until the end of the study. Both dexmedetomidine and fentanyl are colourless liquids, and they were digitally encoded after being diluted to 2 ml so that the researchers who are responsible for postoperative follow-up and data processing are blinded to the group allocation during the whole study period. All patients are also blinded to the group allocation.
A)Anaesthesia induction:
Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicated with intravenous (i.v.) midazolam 1-2 mg and antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intravenously (IV)-administered propofol 2 mg/kg, fentanyle 1 mic kg following which endotracheal intubation will be facilitated by atracurium 0.5 mg / kg. Anesthesia will be maintained with oxygen, air, and isoflurane using controlled ventilation with closed circuit in order to ensure normocarbia. Regular doses of atracurium 0.25 mg / kg will be given every 20 minutes to ensure proper muscle relaxation. After positioning the patient of the surgery, patients will receive their intervention according to group allocation under sterile conditions.
B)Intervention:
Erector Spinae Plane Block:
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.
Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml.
Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml.
Intraoperativeely
The following parameters will be monitored intraoperatively :
HR and MAP and SpO2 and CO2 will be documented at induction, intubation, surgical incision and every 15 min. till the end of surgery.
Post operative
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
50 mic dexmedetomidine which is diluted to 2ml.
100 mic fentanylwhich is also diluted to 2 ml.
Time frame: 24 hours
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
Numerical Rating Scale (NRS) when coughing
Time frame: 24 hours
The total opiod dose postoperatively
Time frame: 24 hours
Duration of analgesia is defined as duration between block administration and time of first analgesic request.
Time frame: 24 hours
Incidence of Postoperative nausea & vomiting
Contact information is provided by the study sponsor or research team.
Abdelrahman Hamdy Mohamed, Doctor
CONTACT
Alaa Mohamed Atia, Professor
CONTACT
Assiut University
Other
Acronym: DEX/Fentanyl
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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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