SpondylolisthesisNCT06398600
Caudal Block Versus Quadratus Lumborum Plane Block in Lumbar Surgery
A study testing Caudal and Quadratus lumborum plane block in people with Spondylolisthesis and Facet Joint Hypertrophy, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Postoperative pain is a common complication after lumbar spine surgery due to inherent tissue damage during surgical procedures. Many analgesic options have been explored. Opioid analgesics carry the risk of respiratory depression. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spondylolisthesis, Facet Joint Hypertrophy, Spinal Canal Stenosis
- What is being tested?
- Caudal and Quadratus lumborum plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2024to 30 Sep 2024
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients (18-60 years old), of either gender undergoing elective lumbar spine fixation surgery.
- Patients with American Society of Anesthesiologists (ASA) physical status I-II.
Who cannot join
- Include patients who refuse.
- Patients with contraindications to regional anesthesia (eg, local infection at site of injection, coagulation abnormalities).
- Patients with spinal deformities or previous lumbar disc surgeries.
- Allergy to local anesthetics, mental disorders as well as drug abuse.
- BMI more than 35
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514
About this study
Official title: Analgesic Effect of Ultrasound Guided Caudal Block Versus Quadratus Lumborum Plane Block in Lumbar Spine Surgery in Adult Patients: A Double Blinded Prospective Comparative Study
Postoperative pain is a common complication after lumbar spine surgery due to inherent tissue damage during surgical procedures.
Many analgesic options have been explored. Opioid analgesics carry the risk of respiratory depression.
Read more
Nonsteroidal anti-inflammatory drugs (NSAIDs) are popular and widely used as first-line treatment for acute pain following spinal surgery, but can provide inadequate analgesia. High doses of NSAIDs have also been linked to non-unions in spinal fusion surgery.
Patient-controlled analgesia or epidural injection analgesia are usually used. One of US guided regional anesthesia methods is the ultrasound-guided caudal block that was first described by Klocke and colleagues in 2003.
One of the more recent techniques that has been described recently is quadratus lumborum plane block(QLB),that is posterior abdominal wall fascial plane block first described by Blanco in 2007.In this study we will compare between analgesic effect of ultrasound guided caudal block to that of ultrasound guided quadratus lumborum plane block as well as safety of both modalities in adult patients undergoing lumbar spine fixation surgeries.
Read the detailed description
This study will be conducted at Fayoum University Hospital after the approval of the local institutional ethics committee and local institutional review board. The study design will be a randomized, double-blind, controlled study. A detailed informed consent form will be signed by eligible patients prior to enrollment and randomization.
Inclusion criteria:
Anesthesia procedure Patients will be randomly allocated into one of three parallel groups (37 in each group) based on sample size. Randomization will be achieved using computer-generated random numbering of each study patient. opaque sealed envelopes will be used and opened in the operating room by a anesthesia resident who will be blinded to the study. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation. Patients will be randomized into three groups.
Group (D) patients who will receive caudal block. Group (QL) patients who will receive posterior quadratus lumborum plane block. Group (C) patients who will not receive any blocks. Preoperative assessment A preoperative patient visit will be done for medical history taking, clinical examination, reassurance, and explaining the method of anesthesia. The study protocol, caudal block, quadratus lumborum plane block and the numerical pain rating score score will be explained to each patient during the preanesthetic counselling. The patient's back will be examined to detect any spinal deformities . Patients will fast for about 6 to 8 hours for solid meals , for 4 hours for non clear liquids and for 2 hours for clear liquids before surgery.
Intraoperative management Monitoring equipment will be connected to the patients included pulse oximetry, non-invasive blood pressure monitoring, five-lead electrocardiogram and capnography. IV access will be established. Patients in the three groups will receive general anesthesia after 5 minutes of pre oxygenation with 100% O2. Anesthesia will be induced with intravenous fentanyl 1mcg/kg, propofol 2 mg/kg and atracurium 0.5 mg/kg. After oral endotracheal intubation, anesthesia will be maintained with isoflurane (1.2%_1.5%) in oxygen _air mixture and atracurium 0.1mg/kg with interval about 20 min.
Block technique After stabilizing the patient hemodynamics, caudal block or quadratus lumborum plane block will be performed in the prone position prior to the skin incision after aseptic preparation of injection area.
Petit between the iliac crest and the costal margin where the trans abdominal muscle is identified . The transducer is then slid posterior until the trans abdominal muscle posterior aponeurosis is identified adjacent to Caudal block
The patient is placed in the prone position typically, a linear transducer is sufficient for the most caudal epidural injection; However, obese patients may require curved transducer. The Ultrasound transducer of (LOGIQ P7 ultrasound) will be first positioned transversely on the midline to obtain a transverse view of the sacral hiatus. The two sacral cornua appear as two hyperechoic structures ,two hyperechoic band structures are present between the two sacral cornua. The superficial is the sacrococcygeal ligament (SCL) and the deep is the dorsal surface of the sacrum. The sacral hiatus is a hypoechoic area between two band-like hyperechoic structures. At this level, the ultrasound probe is rotated 90 degrees to obtain a longitudinal view of the sacral hiatus. in the longitudinal view, the block needle will be inserted using the in plane technique .The block needle can be visualized in real time piercing the SCL entering the hiatus but cannot be visualized beyond the apex of the hiatus. It is therefore proposed to limit the extension of the needle tip beyond the tip of the sacral hiatus to 5 mm to avoid perforating the dura mater, since the distance between the tip of the sacral hiatus and the tip of the dural sac can be less than 6 mm .After the needle is inserted in the caudal canal, 20 ml of 0.25% bupivacaine will be injected. Presence of unidirectional flow, defined as dominant color on color Doppler image, In longitudinal view of sacral hiatus during injection will be reported to be predictive of successful caudal injection and comparable treatment outcomes.
Quadratus Lumborum Plane Block The patient is placed in the prone position , under aseptic conditions with the sterile convex probe is placed in a transverse view at the triangle of the QL muscle and the middle thoracolumbar fascia. The projected needle path is advanced in-plane until the needle tip is visualized between the middle thoracolumbar fascia and the QL muscle .After confirming the location of the needle with 2-3 ml of saline and then aspiration, 20 ml of 0.25% bupivacaine is injected in this plane with confirmation by visualizing hydro dissection . the procedure is applied to the opposite side using the same dose to achieve bilateral block.
Maintenance and recovery Inadequate analgesia that is predicted by increase of heart rate or mean arterial blood pressure by more than 20% of baseline will be managed by 0.5mcg/Kg of fentanyl. Total IV consumption of fentanyl will be recorded. All patients will receive 4mg ondansetron and 1 g paracetamol intravenously 30 minutes before the end of the operation. At the end of surgery, all patients will undergo reversal of muscle relaxation with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg.
After recovery from anesthesia, patients will be transferred to recovery room where heart rate, respiratory rate, saturation and systolic, diastolic and mean arterial blood pressure will be monitored. Quality of analgesia will be assessed using numerical pain rating scale (NPRS) Assessment will be performed at admission to the recovery room, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 18 h, and 24 h postoperative. Rescue analgesia in the form of pethidine 0.5 mg/kg will be administered if is pain moderate to severe according to NPRS≥4 . Time to the 1st rescue analgesic request is recorded.
Also intraoperative or postoperative complications will be recorded such as local anesthetic toxicity, hypotension, nausea, vomiting as well as neurologic complications such as weakness, numbness or any neurological deficits. Also operative time will be recorded.
- Being tested
- Caudal, Quadratus lumborum plane block
- Medical subject headings
- Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaudalProcedure or surgery
In the prone position , linear transducer will be first positioned transversely on the middle line. The two sacral cornua appear as two hyperechoic structures ,two hyperechoic band structures are present between the two sacral cornua. The superficial is the sacrococcygeal ligament (SCL) and the deep is the dorsal surface of the sacrum. The sacral hiatus is a hypoechoic area between two band-like hyperechoic structures. In longitudinal view, the block needle will be inserted using the in plane technique .The block needle can be visualized in real time piercing the SCL entering the hiatus but cannot be visualized beyond the apex of the hiatus. It is therefore proposed to limit the extension of the needle tip beyond the tip of the sacral hiatus to 5 mm to avoid perforating the dura mater. After the needle is inserted in the caudal canal, 20 ml of 0.25% bupivacaine will be injected.
Quadratus lumborum plane blockProcedure or surgery
The patient is placed in the prone position , under aseptic conditions with the sterile convex probe is placed in a transverse view at the triangle of the QL muscle and the middle thoracolumbar fascia. The projected needle path is advanced in-plane until the needle tip is visualized between the middle thoracolumbar fascia and the QL muscle . After confirming the location of the needle with 2-3 ml of saline and then aspiration, 20 ml of 0.25% bupivacaine is injected in this plane with confirmation by visualizing hydro dissection . the procedure is applied to the opposite side using the same dose to achieve bilateral block.
| Study group | Role | What they receive |
|---|---|---|
| Caudal block group | Active comparator | This group of patient receiving caudal block in prone position before the operation. Receives: Procedure: Caudal |
| Quadratus lumborum plane block | Active comparator | This group of patient receiving quadratus lumborum plane block in prone position before the operation. Receives: Procedure: Quadratus lumborum plane block |
| controlled group | No intervention | this group of patient will not receive any blocks, only undergoing operation under general anesthesia and receive only 1 g paracetamol 30 min before end of operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesic request.
duration between time of introducing intervention and time of first analgesic request
Measured: first 24 hours
Secondary outcomes (8)
The postoperative numerical pain rating score for 24 h
The numerical pain rating score is an 11-point scale scored from 0_10 where (0) equal no pain, (1_3) equal mild pain,( 4_6) equal moderate pain and (7_10) equal severe pain.
Measured: for first 24 hours
Total opioid consumption used in first 24 hours .
total dose of opioids consumed
Measured: for first 24 hours
Intraoperative fentanyl consumption.
dose of fentanyl consumed
Measured: during intra operative period
Intraoperative heart rate every 15 minutes.
Heart rate is measured every 15 minutes during the whole duration of operation
Measured: during intra operative period
Intraoperative blood pressure every 15 minutes
Blood pressure is measured every 15 min during the whole duration of operation
Measured: during intra operative period
postoperative heart rate every 2h for 24h.
Heart rate is measured every 2 hours after the end of operation
Measured: for first 24 hours
postoperative blood pressure every 2h for 24h.
Blood pressure is measured every 2 hours after the end of operation
Measured: for first 24 hours
Complications related as local anesthetic toxicity, nausea and vomiting.
any complications detected
Measured: for first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start3 May 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Mohamed mahmoud, Fayoum University Hospital
- Investigators
- Atef Mohamed, MD, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398600
- Sponsor's protocol ID
- M 696
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Klocke R, Jenkinson T, Glew D. Sonographically guided caudal epidural steroid injections. J Ultrasound Med. 2003 Nov;22(11):1229-32. doi: 10.7863/jum.2003.22.11.1229.
PubMed 14620894Korgvee A, Junttila E, Koskinen H, Huhtala H, Kalliomaki ML. Ultrasound-guided quadratus lumborum block for postoperative analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Feb 1;38(2):115-129. doi: 10.1097/EJA.0000000000001368.
PubMed 33186305Chen CP, Tang SF, Hsu TC, Tsai WC, Liu HP, Chen MJ, Date E, Lew HL. Ultrasound guidance in caudal epidural needle placement. Anesthesiology. 2004 Jul;101(1):181-4. doi: 10.1097/00000542-200407000-00028.
PubMed 15220789Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
PubMed 30688787Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
PubMed 15928561
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ultrasound Guided Caudal Block Versus Quadratus Lumborum Plane Block in Lumbar Spine Surgery in Adult Patients: A Double Blinded Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06398600
- Acronym / sponsor ID
- M 696
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 May 2024 (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.
Postoperative pain is a common complication after lumbar spine surgery due to inherent tissue damage during surgical procedures.
Many analgesic options have been explored. Opioid analgesics carry the risk of respiratory depression.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are popular and widely used as first-line treatment for acute pain following spinal surgery, but can provide inadequate analgesia. High doses of NSAIDs have also been linked to non-unions in spinal fusion surgery.
Patient-controlled analgesia or epidural injection analgesia are usually used. One of US guided regional anesthesia methods is the ultrasound-guided caudal block that was first described by Klocke and colleagues in 2003.
One of the more recent techniques that has been described recently is quadratus lumborum plane block(QLB),that is posterior abdominal wall fascial plane block first described by Blanco in 2007.In this study we will compare between analgesic effect of ultrasound guided caudal block to that of ultrasound guided quadratus lumborum plane block as well as safety of both modalities in adult patients undergoing lumbar spine fixation surgeries.
Detailed description
This study will be conducted at Fayoum University Hospital after the approval of the local institutional ethics committee and local institutional review board. The study design will be a randomized, double-blind, controlled study. A detailed informed consent form will be signed by eligible patients prior to enrollment and randomization.
Inclusion criteria:
Anesthesia procedure Patients will be randomly allocated into one of three parallel groups (37 in each group) based on sample size. Randomization will be achieved using computer-generated random numbering of each study patient. opaque sealed envelopes will be used and opened in the operating room by a anesthesia resident who will be blinded to the study. The patient and researcher who collects the data after the block will be blinded to the study group. All study outcomes will be evaluated by a dedicated anesthesiologist who will be blinded to the group allocation. Patients will be randomized into three groups.
Group (D) patients who will receive caudal block. Group (QL) patients who will receive posterior quadratus lumborum plane block. Group (C) patients who will not receive any blocks. Preoperative assessment A preoperative patient visit will be done for medical history taking, clinical examination, reassurance, and explaining the method of anesthesia. The study protocol, caudal block, quadratus lumborum plane block and the numerical pain rating score score will be explained to each patient during the preanesthetic counselling. The patient's back will be examined to detect any spinal deformities . Patients will fast for about 6 to 8 hours for solid meals , for 4 hours for non clear liquids and for 2 hours for clear liquids before surgery.
Intraoperative management Monitoring equipment will be connected to the patients included pulse oximetry, non-invasive blood pressure monitoring, five-lead electrocardiogram and capnography. IV access will be established. Patients in the three groups will receive general anesthesia after 5 minutes of pre oxygenation with 100% O2. Anesthesia will be induced with intravenous fentanyl 1mcg/kg, propofol 2 mg/kg and atracurium 0.5 mg/kg. After oral endotracheal intubation, anesthesia will be maintained with isoflurane (1.2%_1.5%) in oxygen _air mixture and atracurium 0.1mg/kg with interval about 20 min.
Block technique After stabilizing the patient hemodynamics, caudal block or quadratus lumborum plane block will be performed in the prone position prior to the skin incision after aseptic preparation of injection area.
Petit between the iliac crest and the costal margin where the trans abdominal muscle is identified . The transducer is then slid posterior until the trans abdominal muscle posterior aponeurosis is identified adjacent to Caudal block
The patient is placed in the prone position typically, a linear transducer is sufficient for the most caudal epidural injection; However, obese patients may require curved transducer. The Ultrasound transducer of (LOGIQ P7 ultrasound) will be first positioned transversely on the midline to obtain a transverse view of the sacral hiatus. The two sacral cornua appear as two hyperechoic structures ,two hyperechoic band structures are present between the two sacral cornua. The superficial is the sacrococcygeal ligament (SCL) and the deep is the dorsal surface of the sacrum. The sacral hiatus is a hypoechoic area between two band-like hyperechoic structures. At this level, the ultrasound probe is rotated 90 degrees to obtain a longitudinal view of the sacral hiatus. in the longitudinal view, the block needle will be inserted using the in plane technique .The block needle can be visualized in real time piercing the SCL entering the hiatus but cannot be visualized beyond the apex of the hiatus. It is therefore proposed to limit the extension of the needle tip beyond the tip of the sacral hiatus to 5 mm to avoid perforating the dura mater, since the distance between the tip of the sacral hiatus and the tip of the dural sac can be less than 6 mm .After the needle is inserted in the caudal canal, 20 ml of 0.25% bupivacaine will be injected. Presence of unidirectional flow, defined as dominant color on color Doppler image, In longitudinal view of sacral hiatus during injection will be reported to be predictive of successful caudal injection and comparable treatment outcomes.
Quadratus Lumborum Plane Block The patient is placed in the prone position , under aseptic conditions with the sterile convex probe is placed in a transverse view at the triangle of the QL muscle and the middle thoracolumbar fascia. The projected needle path is advanced in-plane until the needle tip is visualized between the middle thoracolumbar fascia and the QL muscle .After confirming the location of the needle with 2-3 ml of saline and then aspiration, 20 ml of 0.25% bupivacaine is injected in this plane with confirmation by visualizing hydro dissection . the procedure is applied to the opposite side using the same dose to achieve bilateral block.
Maintenance and recovery Inadequate analgesia that is predicted by increase of heart rate or mean arterial blood pressure by more than 20% of baseline will be managed by 0.5mcg/Kg of fentanyl. Total IV consumption of fentanyl will be recorded. All patients will receive 4mg ondansetron and 1 g paracetamol intravenously 30 minutes before the end of the operation. At the end of surgery, all patients will undergo reversal of muscle relaxation with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg.
After recovery from anesthesia, patients will be transferred to recovery room where heart rate, respiratory rate, saturation and systolic, diastolic and mean arterial blood pressure will be monitored. Quality of analgesia will be assessed using numerical pain rating scale (NPRS) Assessment will be performed at admission to the recovery room, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 18 h, and 24 h postoperative. Rescue analgesia in the form of pethidine 0.5 mg/kg will be administered if is pain moderate to severe according to NPRS≥4 . Time to the 1st rescue analgesic request is recorded.
Also intraoperative or postoperative complications will be recorded such as local anesthetic toxicity, hypotension, nausea, vomiting as well as neurologic complications such as weakness, numbness or any neurological deficits. Also operative time will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caudal block group | Active comparator | Procedure: CaudalThis group of patient receiving caudal block in prone position before the operation. |
| Quadratus lumborum plane block | Active comparator | Procedure: Quadratus lumborum plane blockThis group of patient receiving quadratus lumborum plane block in prone position before the operation. |
| controlled group | No intervention | –this group of patient will not receive any blocks, only undergoing operation under general anesthesia and receive only 1 g paracetamol 30 min before end of operation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients (18-60 years old), of either gender undergoing elective lumbar spine fixation surgery.
- Patients with American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria (5 listed)
- Include patients who refuse.
- Patients with contraindications to regional anesthesia (eg, local infection at site of injection, coagulation abnormalities).
- Patients with spinal deformities or previous lumbar disc surgeries.
- Allergy to local anesthetics, mental disorders as well as drug abuse.
- BMI more than 35
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 |
|---|---|---|
| CaudalIn the prone position , linear transducer will be first positioned transversely on the middle line. The two sacral cornua appear as two hyperechoic structures ,two hyperechoic band structures are present between the two sacral cornua. The superficial is the sacrococcygeal ligament (SCL) and the deep is the dorsal surface of the sacrum. The sacral hiatus is a hypoechoic area between two band-like hyperechoic structures. In longitudinal view, the block needle will be inserted using the in plane technique .The block needle can be visualized in real time piercing the SCL entering the hiatus but cannot be visualized beyond the apex of the hiatus. It is therefore proposed to limit the extension of the needle tip beyond the tip of the sacral hiatus to 5 mm to avoid perforating the dura mater. After the needle is inserted in the caudal canal, 20 ml of 0.25% bupivacaine will be injected. | Procedure or surgery | Caudal block group |
| Quadratus lumborum plane blockThe patient is placed in the prone position , under aseptic conditions with the sterile convex probe is placed in a transverse view at the triangle of the QL muscle and the middle thoracolumbar fascia. The projected needle path is advanced in-plane until the needle tip is visualized between the middle thoracolumbar fascia and the QL muscle . After confirming the location of the needle with 2-3 ml of saline and then aspiration, 20 ml of 0.25% bupivacaine is injected in this plane with confirmation by visualizing hydro dissection . the procedure is applied to the opposite side using the same dose to achieve bilateral block. | Procedure or surgery | Quadratus lumborum plane block |
Primary outcome
Time to first rescue analgesic request.
Time frame: first 24 hours
duration between time of introducing intervention and time of first analgesic request
8 secondary outcomes
The postoperative numerical pain rating score for 24 h
Time frame: for first 24 hours
Total opioid consumption used in first 24 hours .
Time frame: for first 24 hours
Intraoperative fentanyl consumption.
Time frame: during intra operative period
Intraoperative heart rate every 15 minutes.
Time frame: during intra operative period
Intraoperative blood pressure every 15 minutes
Time frame: during intra operative period
postoperative heart rate every 2h for 24h.
Time frame: for first 24 hours
postoperative blood pressure every 2h for 24h.
Time frame: for first 24 hours
Complications related as local anesthetic toxicity, nausea and vomiting.
Time frame: for first 24 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 19 Nov 2025.
- Background: PubMed 14620894Klocke R, Jenkinson T, Glew D. Sonographically guided caudal epidural steroid injections. J Ultrasound Med. 2003 Nov;22(11):1229-32. doi: 10.7863/jum.2003.22.11.1229.
- Background: PubMed 33186305Korgvee A, Junttila E, Koskinen H, Huhtala H, Kalliomaki ML. Ultrasound-guided quadratus lumborum block for postoperative analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Feb 1;38(2):115-129. doi: 10.1097/EJA.0000000000001368.
- Background: PubMed 15220789Chen CP, Tang SF, Hsu TC, Tsai WC, Liu HP, Chen MJ, Date E, Lew HL. Ultrasound guidance in caudal epidural needle placement. Anesthesiology. 2004 Jul;101(1):181-4. doi: 10.1097/00000542-200407000-00028.
- Background: PubMed 30688787Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
- Background: PubMed 15928561Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
- Individual participant dataSharing planned: Undecided
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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.
Atef Mohamed, MD principal investigator
Faculty of medicine, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal and Quadratus lumborum plane block in people with Spondylolisthesis and Facet Joint Hypertrophy, run by Fayoum University Hospital 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 5 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 19 Nov 2025. 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?
Time to first rescue analgesic request. (time frame: first 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398600, which also lists 5 linked publications.
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 19 Nov 2025.