The Analgesic Effect of Quadratus Lumborum Block and Its Postoperative Implication on Kidney Function

NCT04425174 | Completed

• 1 other identifier: FMASU R 14/2020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Regional anesthesia is frequently used in major surgery in association with general anesthesia to ensure adequate postoperative patient analgesia and to decrease the intra- and postoperative use of systemic analgesic drugs. Epidural analgesia (EP) is considered the standard regional analgesic technique that is widely used in abdominal surgery. Nonetheless, it has some limitations such as in colorectal surgery where complications in the form of muscular weakness, hemodynamic instability, and postural hypotension result in delayed patient ambulation. For these limitations, peripheral nerve blocks can be considered safer with less incidence of complications compared to the central neuraxial blocks especially with the use of ultrasound (US) as a guide in their techniques. Also, avoidance of the hemodynamic instability that may affect the postoperative kidney function can be considered an important issue in patients with risk for postoperative acute kidney injury (AKI). One of the latest techniques in the field of regional anesthesia is the quadratus lumborum (QL) block, which is based on US-guided injection of a local anesthetic agent into the thoracolumbar fascia surrounding the QL muscle. Several different approaches were described depending on the injection sites, for example, lateral, posterior, and anterior approaches . According to the ASRA-ESRA Delphi consensus, there was no consensus on naming quadratus lumborum block types where posterior QL had the strongest consensus in abdominal wall analgesia with 71%. After the QL block, there is evidence that the injectate spreads to the paravertebral space where it blocks the thoracolumbar nerves and the thoracic sympathetic trunk. Because it produces an extensive sensory block leading to adequate postoperative analgesia besides decreasing the systemic analgesic consumption, QL block is now considered an effective regional block that can be used in major abdominal surgery. 40% of the cases diagnosed as having AKI occurred as a postoperative complication. Cardiac surgery carries the highest risk for AKI (18.7%), whereas general surgery comes second (13.2%). The risk factors of developing AKI may be general or causes related to the type and the setting of the surgery. Fluid depletion is one of the major factors that can occur perioperatively and leads to renal hypoperfusion, with subsequent renal arteriolar changes, attempting to maintain a normal glomerular filtration rate. The sympathetic effects of the neuroendocrine hormones may lead to renal vasoconstriction, aiming to redistribute the blood to the medulla; however, it may lead to renal ischemia. The renal blood flow can be assessed by a rapid bed-side noninvasive technique, using the renal Doppler resistive index (RI), which is one of the most fundamental parameters assessing renal perfusion, because it reflects the degree of the vascular resistance inside the kidney vascular bed and can be used to assess the modifications and the changes that occur in the renal blood flow. No previous studies so far discussed the effect of QL block on postoperative creatinine and blood ureal nitrogen (BUN) levels. While, regarding epidural analgesia, multiple articles are investigating the effect of epidural on postoperative kidney function using various indices, such as serum creatinine, BUN, sodium clearance, and urine output. As far as the authors know, this is the first study using the RI renal flow as a comparative parameter between the QL block and EP analgesia. This study aimed to assess the analgesic efficacy of QL block compared with epidural anesthesia as a primary outcome using the 10-point visual analog scale (VAS), time to first morphine requirement, and 24-hour morphine consumption. Also, to study the effect of both on postoperative kidney function as a secondary outcome using serum creatinine and BUN and renal flow assessment using renal Doppler.

Conditions

Anesthesia

Keywords

Quadratus Lumborum block; Renal resistive index; Renal doppler; Epidural anesthesia

Outcome Measures

Primary Outcomes (3)

• Pain score

  Visual analog score will be assessed post operatively. The score is from 0 to 10 with 0 equal no pain while 10 represents the worst pain.

  24 hours

• First morphine dose

  Time of the first morphine dose needed to control post operative pain.

  24 hours

• Cumulative morphine dose

  The total amount of morphine used to control post operative pain

  24 hours

Secondary Outcomes (2)

• Renal doppler

  12 hours

• Laboratory kidney function

  12 hours

Study Arms (2)

QL

QL = 30 patients representing the case group receiving QL block.

Procedure: Quadratous lumborum block

EP

EP = 30 patients representing the control group receiving epidural anesthesia.

Procedure: Epidural anesthesia

Interventions

Quadratous lumborum block PROCEDURE

Quadratus Lumborum (QL) block is a new technique for analgesia of the abdominal wall muscles. Its mechanism depends on the injection of the local anesthetic agent between the abdominal wall muscles into the thoracolumbar fascia surrounding the Quadratus Lumborum muscle by ultrasound (US) guided technique.

QL

Epidural anesthesia PROCEDURE

Epidural analgesia is a gold standard analgesic technique for the majority of abdominal surgeries, yet it has some limitations in some surgeries as colorectal surgeries due to delayed ambulation due to muscular weakness and postural hypotension.

EP

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cases will undergo colorectal surgeries

You may qualify if:

• Patients with an American Society of Anesthesiologists (ASA) physical status I-III.
• Patients aged between 35 and 65 years scheduled for colorectal surgeries.

You may not qualify if:

• We will exclude patients with serious cardio-cerebral vascular diseases, neurological disorders, bleeding disorders as QL block is a deep block, allergies to local anesthetics (LAs), infection at the puncture site, body mass index (BMI)\> 35kg/m2, history of mental illness, and patients who will not consent to the procedure.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Reham M. Hashim

Cairo, 11544, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Reham M Hashim

  Faculty of medicine - Ain shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 11, 2020
• Study Start: June 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: September 22, 2020
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)