Analgesia for Laparotomy in Cancer Patients: Quadratus Lumborum Block

Analgesia for Laparotomy in Cancer Patients:Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block

Regional anesthesia of the abdomen significantly reduce postoperative pain, spare the systemic opioids and decrease postoperative nausea and vomiting. Multiple regional techniques can be performed at the neuro-axis (epidural), the nerve root (paravertebral) and the peripheral nerve (transversus abdominis plane).

Quadratus lumborum (QL) block is an addition into the league of truncal nerve block techniques that has been found to provide analgesia for abdominal surgeries. Several case reports have shown that local anesthetic injection around the quadratus lumborum muscle is effective in providing pain relief after various abdominal operations and in patients with chronic pain.

The study hypothesis is that quadratus lumborum block in single shot may be more superior to transversus abdominus plane block as regard intra-operative and the post-operative analgesia.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Quadratus lumborum block; Other: Transversus abdominis plane block

Detailed Description

This is a prospective randomized controlled study conducted at Oncology Center-Mansoura University.

102 patients were randomly allocated by closed envelope method into 2 equal groups:

• Quadratus lumborum block Group (Q) (n= 51): patients received 15 ml of 0.5% isobaric bupivacaine + 10 ml saline + 50 ug dexmedetomidine + epinephrine (1:100,000) for each side.
• Transversus abdominis plane Group (T) (n= 51): patients received 15 ml of 0.5% isobaric bupivacaine + 10 ml of saline + 50 ug dexmedetomidine + epinephrine (1:100,000) for each side.

All blocks were performed after induction of general anesthesia and approximately 15 min before the skin incision.

• Technique of ultrasound guided quadratus lumborum Block: patient lie in lateral position to obtain appropriate view of quadratus lumborum and transversus abdominins plane extension of lateral abdominal muscles. In this approach, a high-frequency linear transducer (7-12 MHZ) attached to ultrasound machine was placed in anterior axillary line to visualize the typical triple abdominal layers. At the junction of the tapered ends of abdominal muscles and quadratus lumborum, a 21 G cannula needle was inserted in plane and confirmed its position by injecting saline. Under ultrasound guidance, saline separating thoracolumbar fascia from muscle is observed then local anesthetic is injected.
• Technique of ultrasound guided Transversus abdominis plane Block: Patient lie in supine position and high-frequency linear transducer (7-12 MHZ) attached to ultrasound machine placed in anterior axillary line between costal margin and iliac crest to visualize the typical triple abdominal layers. A 21 G cannula needle is then moved forward from an anteromedial position in a posterior and lateral direction using an in-plane technique with the entry point in the skin being separated from the probe in order to improve needle visibility in the long axis. The needle tip is inserted between transversus abdominis muscle and internal oblique muscle then local anesthetic is injected to produce separation between the two muscle.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 35516
      • Oncolgy Center, Mansoura University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for open abdominal cancer surgery.
• American Society of Anesthesiologists physical status grade I and grade II.

Exclusion Criteria:

1. Patient refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, …...) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at site of the block. 6. Known intolerance to the study drugs. 7. Body Mass Index > 40 Kg/m2.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadratus lumborum block Group; ultrasound guided	Other: Quadratus lumborum block; 15 ml of 0.5% isobaric bupivacaine + 10 ml saline + 50 micro gram dexmedetomidine + epinephrine (1:100,000) for each side.; Other Names: Group Q
Active Comparator: Transversus abdominis plane block Group; ultrasound guided	Other: Transversus abdominis plane block; 15 ml of 0.5% isobaric bupivacaine + 10 ml of saline + 50 micro gram dexmedetomidine + epinephrine (1:100,000) for each side.; Other Names: Group T

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of morphine consumption	milligram	postoperative: in the first 24-hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time to the first analgesic requirement	hours	postoperative: in the first 24-hour
pain intensity by visual analogue scale (VAS)	0-10 point visual analogue scale. 0 is no pain, 10 the worst pain.	postoperatively, at 0, 2, 4, 8, 16 and 24 hours
sedation score by Modified Ramsay sedation score	1-6 scale, 1. Anxious, agitated, restless. 2. Awake, but tranquil and cooperative. 3. Responsive to commands only. 4. Brisk response to light glabellar tap or loud auditory stimulus. 5. Sluggish response to light glabellar tap or loud auditory stimulus. 6. No response to light glabellar tap or loud auditory stimulus.	postoperative, at 0, 2, 4, 8, 16 and 24 hours
postoperative nausea, vomiting	percent	postoperative in the first 24 hours
Mean blood pressure	millimeter mercury	intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively.
Heart rate	beat/minute	intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively.

Collaborators and Investigators

• Sponsor: Alaa Mazy

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2016
• Primary Completion (Actual): July 15, 2017
• Study Completion (Actual): July 15, 2017

Study Registration Dates

• First Submitted: October 28, 2017
• First Submitted That Met QC Criteria: October 28, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MS/15.12.97

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after publication
• IPD Sharing Time Frame: no limit
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

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