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OpenTrials
Completed

NCT Number: NCT03328390

Analgesia for Laparotomy in Cancer Patients: Quadratus Lumborum 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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncolgy Center, Mansoura University,

Al Mansurah, DK, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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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Treatment and study plan

Quadratus lumborum block

Other

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

Transversus abdominis plane block

Other

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

Primary outcomes

  1. The total dose of morphine consumption

    Time frame: postoperative: in the first 24-hour

    milligram

Secondary outcomes

  1. the time to the first analgesic requirement

    Time frame: postoperative: in the first 24-hour

    hours

  2. pain intensity by visual analogue scale (VAS)

    Time frame: postoperatively, at 0, 2, 4, 8, 16 and 24 hours

    0-10 point visual analogue scale. 0 is no pain, 10 the worst pain.

  3. sedation score by Modified Ramsay sedation score

    Time frame: postoperative, at 0, 2, 4, 8, 16 and 24 hours

    1-6 scale, 1. Anxious, agitated, restless. 2. Awake, but tranquil and cooperative. 3. Responsive to commands only.

    • Brisk response to light glabellar tap or loud auditory stimulus. 5. Sluggish response to light glabellar tap or loud auditory stimulus.
    • No response to light glabellar tap or loud auditory stimulus.
  4. postoperative nausea, vomiting

    Time frame: postoperative in the first 24 hours

    percent

  5. Mean blood pressure

    Time frame: intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively.

    millimeter mercury

  6. Heart rate

    Time frame: intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively.

    beat/minute

Sponsors and collaborators

Lead sponsor

Alaa Mazy

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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