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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Cancer
• Intervention / Treatment: Other: quadratus lumborum; Other: transversus abdominis plane

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

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: yahya m wahba, assist professor; Phone Number: 01211313554; Email: yahyawahba@ymail.com
• Study Contact Backup: Name: adel abdel ghaffar; Phone Number: 01210101001; Email: adelghaffar49@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Nevert Adel Abdel Ghaffar
    • Contact: Nevert A Abdel Ghaffar, MD; Phone Number: 01223947977; Email: nevertadel@mans.edu.eg
    • Contact: Yahya M Wahba, MD; Phone Number: 01211313554; Email: yahyawahba@ymail.com
    • Sub-Investigator: nevert a abdel ghaffar, assist prof
    • Principal Investigator: ghada f amer, assist prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of morphine	amount of morphine in mg	in the first 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
visual analog score	ranging from 0 to 10, where 0 no pain and 10 maximum pain	postoperatively 2 hours
visual analog score	ranging from 0 to 10, where 0 no pain and 10 maximum pain	postoperatively at 4 hours
visual analog score	ranging from 0 to 10, where 0 no pain and 10 maximum pain	postoperatively at 6 hours
visual analog score	ranging from 0 to 10, where 0 no pain and 10 maximum pain	postoperatively at 12 hours
visual analog score	ranging from 0 to 10, where 0 no pain and 10 maximum pain	postoperatively at 24 hours

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: R.22.08.1787

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No