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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03973398
Other study ID # QLB in Nephrectomy
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date July 1, 2020
Est. completion date September 1, 2021

Study information

Verified date February 2020
Source Assiut University
Contact Sherif Bekhet
Phone 00201155538773
Email bekhetsherif89@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- Primary outcome: to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block.

- Secondary outcome: to evaluate the efficacy of Quadratus Lumborum Block in the control of postoperative pain in patients undergoing Nephrectomy surgery, hemodynamics, any complications and patients' satisfaction..


Description:

A variant of the ultrasound-guided transversus abdominis plane (TAP) block was first described in an abstract, in which local anesthetic injection occurs at the point where the internal oblique and transversus abdominis muscles taper off and adjoin the lateral border of quadratus lumborum (QL) muscle.

Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery.

However, there is large disagreement regarding the best approach for administering the block because of unclear mechanisms responsible for the effects and complicated nomenclature system. Nephrectomy for patients with renal cell carcinoma (RCC) was first described in 1969. Surgical treatment varies with the pathology. Simple nephrectomy is the preferred option for those with non-neoplastic disease (e.g. trauma, non-functioning kidney with chronic infection) with radical nephrectomy being preferred in those with neoplastic disease. Radical nephrectomy implies resection of the whole of Gerota's fascia, including the perinephric fat, lymphatics, and the ipsilateral adrenal gland. Here the investigators are going to compare the Anterior (subcostal) approach to the Posterior approach to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Nephrectomy surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date September 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Both sex

- Age: 18-60 years.

- ASA I and II

- Elective surgery

Exclusion Criteria:

- Patient's refusal.

- Allergy to local anesthetics.

- Peripheral neuropathy.

- Bleeding diathesis.

- Inflammation or infection over injection site.

- Morbid obesity.

- Patients on previous opioid therapy.

- Psychiatric disorders.

- Emergency surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sherif Mahmoud Mohammed Bekhet

Outcome

Type Measure Description Time frame Safety issue
Primary Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Numeric Rating Scale. : to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by The Numeric rating scale (NRS) both resting and ambulatory which measures pain as felt by the patient every two hours for the first 24 hours then every six hours for the second day. the Numeric rating scale is a scale from 0 to 10 with '0' being lowest pain or no pain and '10' is the worst pain felt. baseline
Primary Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Revised American Pain Society Patient Outcome Questionnaire. to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by the Revised American Pain Society Patient Outcome Questionnaire which is a set of questions answered by the patient to evaluate the patient's satisfaction and for quality improvement of pain management in hospitalized patients baseline
Secondary using the numeric rating scale to determine the effect of Quadratus Lumborum block in reducing the postoperative pain in patients undergoing nephrectomy surgery to evaluate the efficacy of Quadratus Lumborum Block in the control of postoperative pain in patients undergoing Nephrectomy surgery, hemodynamics, any complications and patients' satisfaction.The Numeric rating scale (NRS) both resting and ambulatory which measures pain as felt by the patient every two hours for the first 24 hours then every six hours for the second day. the Numeric rating scale is a scale from 0 to 10 with '0' being lowest pain or no pain and '10' is the worst pain felt. baseline
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