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

NCT05533424 | Unknown Phase 3

• 1 other identifier: R.22.08.1787
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• The total dose of morphine

  amount of morphine in mg

  in the first 24 hours after surgery

Secondary Outcomes (6)

• visual analog score

  postoperatively at 30 min and 2, 4, 6, 12, and 24 hours

• visual analog score

  postoperatively 2 hours

• visual analog score

  postoperatively at 4 hours

• visual analog score

  postoperatively at 6 hours

• visual analog score

  postoperatively at 12 hours

Study Arms (2)

Group quadratus lumborum

ACTIVE COMPARATOR

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

Other: quadratus lumborum

Group transversus abdominis plane

ACTIVE COMPARATOR

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

Other: transversus abdominis plane

Interventions

quadratus lumborum 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 quadratus lumborum

transversus abdominis plane 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

Group transversus abdominis plane

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Nevert Adel Abdel Ghaffar

Al Mansurah, Egypt

RECRUITING

Central Study Contacts

yahya m wahba, assist professor

CONTACT

01211313554; yahyawahba@ymail.com

adel abdel ghaffar

CONTACT

01210101001; adelghaffar49@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. of anesthesia and pain management

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 15, 2023
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

EG (1)