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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05890248
Other study ID # Mohamed A Aboelsuod
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 1, 2024

Study information

Verified date June 2023
Source Azhar University
Contact mohamed Aboelsuod, MD
Phone 00201091945931
Email abosoad.mohamed2017@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Open renal surgeries are associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or by systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension, headache, nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting , constipation , allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank (T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10). Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami. Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic. PVB is effective for pain relief in the thoracic, abdominal and limb regions. primary aim was to compare postoperative opioid consumption rates at 24 h. Secondary end points were to compare pain scores and hemodynamic variables.


Description:

This was randomized, controlled, single-blinded study, conducted in urology operating theatre, Al-Azhar university hospital. Forty eight patients of both sex and aged from 21-65 years in period between February 2022 to January 2023 scheduled for elective open renal surgeries under general anesthesia were enrolled in this study. The procedure was explained to the patient and informed consent was signed after his agreement then the patient was classified to one of three groups


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: - Inclusion criteria: Adult patients of both sex, (21-65 years) with renal surgeries with ASA I , II score. Exclusion criteria - Patient's refusal. - Patients with ASA (III , IV) score. - Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 ) - Infection at the injection site. - Allergy to local anesthetics. - Patients receiving opioids for chronic analgesic therapy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Technique
Paravertebral block versus Erector spinea block versus quadratus lamborum block

Locations

Country Name City State
Egypt Azhar University Cairo

Sponsors (1)

Lead Sponsor Collaborator
mohamed A Aboelsuod, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total morphine requirements 24 hours postoperatively 24 hours post operative
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