AnesthesiaNCT04425174
The Analgesic Effect of Quadratus Lumborum Block and Its Postoperative Implication on Kidney Function
An observational study of Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Quadratous lumborum block and Epidural anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2020to 22 Sep 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases will undergo colorectal surgeries
Who may be able to join
- Patients with an American Society of Anesthesiologists (ASA) physical status I-III.
- Patients aged between 35 and 65 years scheduled for colorectal surgeries.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effect of Bilateral Quadratus Lumborum Block and Its Postoperative Implication on Kidney Function in Colorectal Surgery: a Comparative Randomized Control Trial Study With Epidural Anesthesia.
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).
Read more
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.
Read the detailed description
- Study place: Ain Shams University Hospitals.
- Written informed consent will be taken from all patients.
- Patients with an American Society of Anesthesiologists (ASA) physical status I-III, aged between 35 and 65 years were included in this study and scheduled for short colorectal surgery (2-4 hours), such as segmental colectomies and polypectomy using either the sub umbilical incision or laparoscopic technique. Patients with major cardiac or cerebral vascular diseases, bleeding disorders (known contraindication for EP anesthesia and in QL which is considered a deep block), abnormal kidney functions (elevated creatinine, BUN level, or history of renal disease), and neurological disorders were excluded. Patients with known allergy to local anesthetics, puncture site infection, and body mass index (BMI) of >35 kg/m2 were also excluded. Also, patients with intra-operative complications such as hemodynamic instability and unexpected prolonged surgical duration were excluded. Patients who refused to consent to the study were not enrolled, without any discontinuation of their management.
The selected patients were randomized using an automated computer-assisted method (www.randomizer.org), which divided them into 2 groups: the control group (EP) received epidural anesthesia, whereas the study group (QL) received a QL block. The interventions were done by well-experienced anesthesiologists.
Renal Doppler. An experienced radiologist performed the renal Doppler with at least 5 years experience in the doppler field being blinded to the patients' data. A renal Doppler study was performed for both groups preoperatively and postoperatively. Patients were asked to lie supine or in lateral positions. The ultrasound (US) probe was applied to the anterior or midaxillary line with the probe in a transverse direction until the kidney was adequately visualized. The intrarenal and main renal arteries were assessed using color and pulse wave Doppler. The intrarenal arteries assessment was repeated at the upper, mid, and lower pole levels of each kidney. Also, the renal RI of the main renal artery was measured bilaterally. All measurements for each patient were collected and the average RI was calculated. The normal RI is considered when the value was <0.7. The renal Doppler was assessed within 24 hours pre-operative and within 2-3 hours after surgery completion.
Patient preparation. Patients who fasted for 8 hours, with full clinical and laboratory results, were examined for any exclusion criteria with specific concerns with regard to kidney function. 12 hours before the scheduled time for surgery, renal Doppler was performed to measure the renal RI of all patients, before starting to fast for surgery and after adequate hydration was checked, based on his ward fluid chart.
Inside the operating room. The standard monitoring, including electrocardiogram (ECG), oxygen saturation, non-invasive blood pressure, and capnogram for end-tidal carbon dioxide (ETCO2), were applied. Infusion of Ringer's lactate solution (8 mL/kg) was started through a wide bore cannula. IV midazolam 0.05 mg/kg was given as a premedication before the induction of anesthesia by 2 μg/kg fentanyl, 2 mg/kg propofol, and 0.5 mg/kg atracurium. An endotracheal tube was inserted to initiate mechanical ventilation while keeping the ETCO2 in the range of 35-45 mmHg. Anesthesia maintenance was performed with 1.5% isoflurane and oxygen and topped up with IV atracurium 0.5 mg/kg every 20 minutes. The urinary output was followed up using a urinary catheter. IV fentanyl dose of 1 μg/kg was administered, in response to an increase in blood pressure or heart rate of >20% of the baseline measurement. Continuous ECG, blood pressure, and pulse saturation were monitored. To ensure an adequate fluid balance, fluid input, fluid output (urine and third space loss), blood loss, and central venous pressure were recorded. The inhalational anesthetic isoflurane was discontinued at the end of the surgery, followed by the administration of IV neostigmine of 0.05 mg/kg and atropine of 0.02 mg/kg, to reverse the residual neuromuscular block. The trachea was extubated after spontaneous breathing returned.
Epidural analgesia. Epidural analgesia was performed before the induction of general anesthesia by a well-experienced anesthesiologist with at least 5 years experience in local and regional anesthesia. Patients were in a sitting position leaning forward with the legs supported on a chair. Complete skin asepsis with povidone-iodine (7.5%), was applied followed by draping. An 18-gauge Tuohy epidural needle was inserted into the intervertebral space T9-T10, using a vacuum catheter aspiration technique followed by the epidural catheter insertion. The epidural was activated at the end of the operation using 10 mL of 0.25% bupivacaine as a bolus followed by a continuous epidural infusion using 0.125% bupivacaine, at a rate of 6 mL/hour, to be continued for up to 24 hours postoperatively.
QL block technique. A bilateral posterior approach, a US-guided QL block was applied after anesthesia induction by a well-experienced anesthesiologist with at least 5 years experience in local and regional anesthesia, using Honda electronics HS-2100 portable US machine (Honda Electronics CO., LTD, Japan). The patient was in a supine position with a pillow under his back. Povidone-iodine (7.5%) was used to sterilize the area above the iliac crest at the level of the anterior axillary line, followed by draping before the application of a high-frequency superficial probe (9-11 MHz). The probe was adjusted until visualization of the external oblique muscle, the internal oblique muscle, and the transversus abdominis muscle. Then the probe was moved posteriorly until the thoracolumbar fascia covering the QL muscle was visualized. The needle was inserted just above the upper edge of the probe and pierced the muscles until it reached the posterior aspect of the QL muscle. Aspiration was done to ensure that there is no blood and to ensure extravascular injection to avoid the undesirable systemic effect. The correct site was confirmed through saline injection (hydro dissection); 25 mL of 0.25% bupivacaine were injected on each side.
Fluid balance was maintained throughout the operation, using a fluid chart to avoid any hemodynamic instability that might affect the objective of this study.
Postoperative study parameters. Patients were transferred to the intermediate care unit, for continuous observation for 24 hours. A 10-point visual analog scale (VAS) was used to assess pain; with 0 being no pain and number 10 being the worst pain. The VAS score was assessed immediately after patients' transfer from the theater room (0 hours) then 2, 6, 8, 12, 18, and 24 hours postoperative. The following parameters were assessed by a blinded anesthesiologist to the aim of the study:
- The time required for the first morphine dose and the cumulative morphine consumption for 24 hours were recorded as a primary outcome. Morphine was given at a dose of 0.05 mg/kg when the VAS score was >4.
- Postoperative kidney function was assessed using laboratory and US Doppler indices to compare it with the preoperative values, as a secondary outcome. Laboratory tests included serum creatinine and blood urea nitrogen (BUN) and were compared with preoperative values.
- Conditions
- Anesthesia
- Being tested
- Quadratous lumborum block, Epidural anesthesia
- Keywords
- Quadratus Lumborum block, Renal resistive index, Renal doppler, Epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratous lumborum blockProcedure or surgery
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.
Epidural anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| QL | QL = 30 patients representing the case group receiving QL block. Receives: Procedure: Quadratous lumborum block | |
| EP | EP = 30 patients representing the control group receiving epidural anesthesia. Receives: Procedure: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
First morphine dose
Time of the first morphine dose needed to control post operative pain.
Measured: 24 hours
Cumulative morphine dose
The total amount of morphine used to control post operative pain
Measured: 24 hours
Secondary outcomes (2)
Renal doppler
Measurement of the renal artery resistive index compared to the pre-operative measurements.
Measured: 12 hours
Laboratory kidney function
Assessment of the serum creatinine and blood urea nitrogen (BUN) to be compared with the pre-operative values
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Jun 2020
- Primary completion15 Aug 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mustafa Hashim, Ain Shams University
- Investigators
- Reham M Hashim, Principal investigator, Faculty of medicine - Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425174
- Sponsor's protocol ID
- FMASU R 14/2020
- Status last verified
- Nov 2021
- First submitted
- 6 Jun 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Bilateral Quadratus Lumborum Block and Its Postoperative Implication on Kidney Function in Colorectal Surgery: a Comparative Randomized Control Trial Study With Epidural Anesthesia.
- ClinicalTrials.gov ID
- NCT04425174
- Acronym / sponsor ID
- FMASU R 14/2020
- Conditions
- Anesthesia
- Keywords
- Quadratus Lumborum block, Renal resistive index, Renal doppler, Epidural anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study place: Ain Shams University Hospitals.
- Written informed consent will be taken from all patients.
- Patients with an American Society of Anesthesiologists (ASA) physical status I-III, aged between 35 and 65 years were included in this study and scheduled for short colorectal surgery (2-4 hours), such as segmental colectomies and polypectomy using either the sub umbilical incision or laparoscopic technique. Patients with major cardiac or cerebral vascular diseases, bleeding disorders (known contraindication for EP anesthesia and in QL which is considered a deep block), abnormal kidney functions (elevated creatinine, BUN level, or history of renal disease), and neurological disorders were excluded. Patients with known allergy to local anesthetics, puncture site infection, and body mass index (BMI) of >35 kg/m2 were also excluded. Also, patients with intra-operative complications such as hemodynamic instability and unexpected prolonged surgical duration were excluded. Patients who refused to consent to the study were not enrolled, without any discontinuation of their management.
The selected patients were randomized using an automated computer-assisted method (www.randomizer.org), which divided them into 2 groups: the control group (EP) received epidural anesthesia, whereas the study group (QL) received a QL block. The interventions were done by well-experienced anesthesiologists.
Renal Doppler. An experienced radiologist performed the renal Doppler with at least 5 years experience in the doppler field being blinded to the patients' data. A renal Doppler study was performed for both groups preoperatively and postoperatively. Patients were asked to lie supine or in lateral positions. The ultrasound (US) probe was applied to the anterior or midaxillary line with the probe in a transverse direction until the kidney was adequately visualized. The intrarenal and main renal arteries were assessed using color and pulse wave Doppler. The intrarenal arteries assessment was repeated at the upper, mid, and lower pole levels of each kidney. Also, the renal RI of the main renal artery was measured bilaterally. All measurements for each patient were collected and the average RI was calculated. The normal RI is considered when the value was <0.7. The renal Doppler was assessed within 24 hours pre-operative and within 2-3 hours after surgery completion.
Patient preparation. Patients who fasted for 8 hours, with full clinical and laboratory results, were examined for any exclusion criteria with specific concerns with regard to kidney function. 12 hours before the scheduled time for surgery, renal Doppler was performed to measure the renal RI of all patients, before starting to fast for surgery and after adequate hydration was checked, based on his ward fluid chart.
Inside the operating room. The standard monitoring, including electrocardiogram (ECG), oxygen saturation, non-invasive blood pressure, and capnogram for end-tidal carbon dioxide (ETCO2), were applied. Infusion of Ringer's lactate solution (8 mL/kg) was started through a wide bore cannula. IV midazolam 0.05 mg/kg was given as a premedication before the induction of anesthesia by 2 μg/kg fentanyl, 2 mg/kg propofol, and 0.5 mg/kg atracurium. An endotracheal tube was inserted to initiate mechanical ventilation while keeping the ETCO2 in the range of 35-45 mmHg. Anesthesia maintenance was performed with 1.5% isoflurane and oxygen and topped up with IV atracurium 0.5 mg/kg every 20 minutes. The urinary output was followed up using a urinary catheter. IV fentanyl dose of 1 μg/kg was administered, in response to an increase in blood pressure or heart rate of >20% of the baseline measurement. Continuous ECG, blood pressure, and pulse saturation were monitored. To ensure an adequate fluid balance, fluid input, fluid output (urine and third space loss), blood loss, and central venous pressure were recorded. The inhalational anesthetic isoflurane was discontinued at the end of the surgery, followed by the administration of IV neostigmine of 0.05 mg/kg and atropine of 0.02 mg/kg, to reverse the residual neuromuscular block. The trachea was extubated after spontaneous breathing returned.
Epidural analgesia. Epidural analgesia was performed before the induction of general anesthesia by a well-experienced anesthesiologist with at least 5 years experience in local and regional anesthesia. Patients were in a sitting position leaning forward with the legs supported on a chair. Complete skin asepsis with povidone-iodine (7.5%), was applied followed by draping. An 18-gauge Tuohy epidural needle was inserted into the intervertebral space T9-T10, using a vacuum catheter aspiration technique followed by the epidural catheter insertion. The epidural was activated at the end of the operation using 10 mL of 0.25% bupivacaine as a bolus followed by a continuous epidural infusion using 0.125% bupivacaine, at a rate of 6 mL/hour, to be continued for up to 24 hours postoperatively.
QL block technique. A bilateral posterior approach, a US-guided QL block was applied after anesthesia induction by a well-experienced anesthesiologist with at least 5 years experience in local and regional anesthesia, using Honda electronics HS-2100 portable US machine (Honda Electronics CO., LTD, Japan). The patient was in a supine position with a pillow under his back. Povidone-iodine (7.5%) was used to sterilize the area above the iliac crest at the level of the anterior axillary line, followed by draping before the application of a high-frequency superficial probe (9-11 MHz). The probe was adjusted until visualization of the external oblique muscle, the internal oblique muscle, and the transversus abdominis muscle. Then the probe was moved posteriorly until the thoracolumbar fascia covering the QL muscle was visualized. The needle was inserted just above the upper edge of the probe and pierced the muscles until it reached the posterior aspect of the QL muscle. Aspiration was done to ensure that there is no blood and to ensure extravascular injection to avoid the undesirable systemic effect. The correct site was confirmed through saline injection (hydro dissection); 25 mL of 0.25% bupivacaine were injected on each side.
Fluid balance was maintained throughout the operation, using a fluid chart to avoid any hemodynamic instability that might affect the objective of this study.
Postoperative study parameters. Patients were transferred to the intermediate care unit, for continuous observation for 24 hours. A 10-point visual analog scale (VAS) was used to assess pain; with 0 being no pain and number 10 being the worst pain. The VAS score was assessed immediately after patients' transfer from the theater room (0 hours) then 2, 6, 8, 12, 18, and 24 hours postoperative. The following parameters were assessed by a blinded anesthesiologist to the aim of the study:
- The time required for the first morphine dose and the cumulative morphine consumption for 24 hours were recorded as a primary outcome. Morphine was given at a dose of 0.05 mg/kg when the VAS score was >4.
- Postoperative kidney function was assessed using laboratory and US Doppler indices to compare it with the preoperative values, as a secondary outcome. Laboratory tests included serum creatinine and blood urea nitrogen (BUN) and were compared with preoperative values.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL | – | Procedure: Quadratous lumborum blockQL = 30 patients representing the case group receiving QL block. |
| EP | – | Procedure: Epidural anesthesiaEP = 30 patients representing the control group receiving epidural anesthesia. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will undergo colorectal surgeries
Key inclusion criteria (2 listed)
- Patients with an American Society of Anesthesiologists (ASA) physical status I-III.
- Patients aged between 35 and 65 years scheduled for colorectal surgeries.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratous lumborum blockQuadratus 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. | Procedure or surgery | QL |
| Epidural anesthesiaEpidural 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. | Procedure or surgery | EP |
Primary outcome
Pain score
Time frame: 24 hours
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.
First morphine dose
Time frame: 24 hours
Time of the first morphine dose needed to control post operative pain.
Cumulative morphine dose
Time frame: 24 hours
The total amount of morphine used to control post operative pain
2 secondary outcomes
Renal doppler
Time frame: 12 hours
Laboratory kidney function
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham M Hashim principal investigator
Faculty of medicine - Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.