Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.

NCT ID: NCT05533424

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-15

Brief 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.

Detailed 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

Conditions

Abdominal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group 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

Group Type: ACTIVE_COMPARATOR

quadratus lumborum

Intervention Type: OTHER

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

Group 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

Group Type: ACTIVE_COMPARATOR

transversus abdominis plane

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Nevert Adel

assist. prof. of anesthesia and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nevert Adel Abdel Ghaffar

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

yahya m wahba, assist professor

Role: CONTACT

yahyawahba@ymail.com

01211313554

adel abdel ghaffar

Role: CONTACT

adelghaffar49@gmail.com

01210101001

Facility Contacts

Nevert A Abdel Ghaffar, MD

Role: primary

nevertadel@mans.edu.eg

01223947977

Yahya M Wahba, MD

Role: backup

yahyawahba@ymail.com

01211313554

Other Identifiers

R.22.08.1787

Identifier Type: -

Identifier Source: org_study_id