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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05533424
Other study ID # R.22.08.1787
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 1, 2022
Est. completion date December 15, 2023

Study information

Verified date September 2022
Source Mansoura University
Contact yahya m wahba, assist professor
Phone 01211313554
Email yahyawahba@ymail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Abdominal surgery is usually associated with severe postoperative pain. The transverse abdominal plane (TAP) block is considered an effective means for pain control in such cases. The quadratus lumborum (QL) block is another option for the management of postoperative pain. The aim of this study is to evaluate the efficacy and safety of quadrates lumborum blocks and Transversus abdominis plane blocks for pain management after abdominal cancer surgery.


Description:

Postoperative pain is severe in patients undergoing abdominal surgery, and severe pain not only affects the rate of recovery of patients but also induces a series of pathophysiological reactions. Therefore, it is very important for perioperative patients to have a safe and effective pain management model. Although classic postoperative analgesia methods can provide effective pain relief after surgery, their administration has a well-defined risk of side effects. Recently, with the rise in enhanced recovery after surgery, nerve blocks have become the key link in multimodal analgesic regimes. As effective constituents of multimode analgesia, quadratus lumborum (QL) block and transversus abdominis plane (TAP) block are mainly used for postoperative analgesia in abdominal surgery. Aim of this study is to compare between the analgesic effecacy of quadrates lumborum block and transverses abdominal plane block


Recruitment information / eligibility

Status Recruiting
Enrollment 98
Est. completion date December 15, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Patients included in the study, aged 20-60 years, - with ASA Physical Status Class I and II, - scheduled for abdominal cancer surgery under general anesthesia Exclusion Criteria: - infection at injection site, - allergy to local anesthetics, - coagulation disorders, - physical or mental diseases which could interfere with the evaluation of pain scores - kidney failure or liver failure.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
quadratus lumborum
the patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied
transversus abdominis plane
the probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side

Locations

Country Name City State
Egypt Nevert Adel Abdel Ghaffar Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The total dose of morphine amount of morphine in mg in the first 24 hours after surgery
Secondary visual analog score ranging from 0 to 10, where 0 no pain and 10 maximum pain postoperatively at 30 min and 2, 4, 6, 12, and 24 hours
Secondary visual analog score ranging from 0 to 10, where 0 no pain and 10 maximum pain postoperatively 2 hours
Secondary visual analog score ranging from 0 to 10, where 0 no pain and 10 maximum pain postoperatively at 4 hours
Secondary visual analog score ranging from 0 to 10, where 0 no pain and 10 maximum pain postoperatively at 6 hours
Secondary visual analog score ranging from 0 to 10, where 0 no pain and 10 maximum pain postoperatively at 12 hours
Secondary visual analog score ranging from 0 to 10, where 0 no pain and 10 maximum pain postoperatively at 24 hours
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