Post Operative AnalgesiaNCT05174364
Epidural Versus Quadratus Lamborum Block in Adult Open Nephrectomies
An observational study of Post Operative Analgesia, run by Assiut University.
Trial summary
Our primary objective is to compare the effectiveness of bilateral QLB and epidural analgesia for postoperative management using VAS measured in PACU until 24 hours after surgery in patients undergoing elective open nephrectomies under GA. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Post Operative Analgesia
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Feb 2023
- 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 20 to 60 years
- All sexes
- Adult
Study population: Any patient fulfilling the inclusion criteria participating in our study .
Who may be able to join
- Patients of American Society of Anesthesiologists (ASA) class I or II physical status.
- Age:20-60 years old.
- Patients scheduled for open nephrectomies .
- Gender: both
Who cannot join
- Patient refusal.
- Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- Morbid obesity (BMI >35).
- Patient with known hypersensitivity to amide local anesthetics or morphine.
- Patient with any contraindication for intrathecal anesthesia, e.g. coagulopathy.
- Psychiatric disorders, which will make observational pain intensity assessment difficult.
- Pregnancy.
- Skin lesions or wounds at the puncture site of the proposed block .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epidural Versus Quadratus Lamborum Block for Postoperative Analgesia in Adult Open Nephrectomies : A Randomized Double Blind Controlled Trial
Our primary objective is to compare the effectiveness of bilateral QLB and epidural analgesia for postoperative management using VAS measured in PACU until 24 hours after surgery in patients undergoing elective open nephrectomies under GA. The secondary outcomes include: The 1st time to rescue analgesia and total amount of opioid consumption throughout the first postoperative day. hemodynamic variables. Any complications as postoperative nausea and vomiting (PONV) and sedation. The sensory block coverage \& the Bromage score at 2, 6, 12, and 24 hours after anesthesia recovery and duration of urinary catheter usage. Duration of PACU stay and postoperative duration of hospitalization and Patients' satisfaction.
Read the detailed description
Open surgery remains basic surgery for patients requiring radical or partial nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. The physiopathology of acute pain is explained as it is mediated by inflammatory cell infiltration, activation of the pain pathways in the spinal cord, and reflexive muscle spasm. All these three mechanisms of acute pain are typically ameliorated during the postoperative recovery. Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction.
QLB has been introduced as a component of multimodal analgesia for thoracic and abdominal surgeries as:
cesarean section, hip arthroplasty, inguinal hernia repair and nephrectomies. It provides a great spread of local anesthesia which allows anesthesia from T6 - L2 and provides loss of somatic and visceral pain. The QLB was initially described by R.Blanco where the local anesthetic (LA) was injected at the anterolateral aspect of the QL muscle (type 1 QLB). Later, J.
Børglum used the posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type 3 QLB). Recently, R. Blanco described another approach by injecting the LA at the posterior aspect of the QL muscle (type 2 QLB), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is less. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle. QLBs may be particularly useful in nephrectomy as it lacks the adverse effects associated with patient controlled analgesia including nausea, vomiting, sedation, and respiratory depression, as well as side effects of patient controlled epidural analgesia such as pruritus hypotension, and urinary retention. Our hypothesis is that performing ultrasound guided QLB will be more superior or equal to epidural block in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia
- Conditions
- Post Operative Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Block | Epidural block for the control group will be done before induction of general anesthesia. Patients will be positioned in the sitting position, an 18-gauge Tuohy needle will be inserted into epidural space of Th 11-12 intervertebral space under aseptic condition. In the medial approach, the site of the insertion of the needle is between the spaces created by the vertebral spinous processes. Upon locating the desired spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle | |
| Quadratus Lumborum Block | Bilateral QL block type 3 (anterior) for the intervention group will be performed on both sides of the patient after induction of general anesthesia. Patient will be positioned in semi-lateral decubitus and using low-frequency ultrasonography (USG) guidance attached to inferior lumbar region (Petit's triangle) that is consisted of inferior iliac crest and bordered by two muscles such as latissimus dorsi muscle in the posterior, abdominal external oblique muscle in the anterior. The USG will display the Shamrock sign, where the transverse process of vertebrae L4 role as the trunk, erector spinae muscle on the posterior side, psoas major (PM) on the anterior side, and QL muscle on the lateral side. After the visualization of QL and PM muscles, the Contiplex R needle will be directed parallel to the posterior side of the ultrasound probe until the tip of needle is confirmed in the border of QL and PM muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the effectiveness of bilateral QLB and epidural analgesia
postoperative pain management using visual analog scale measured in postanesthesia care unit
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 62 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SABastawy, Assiut University
- Investigators
- Kelani A. Abd El-Salam, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174364
- Sponsor's protocol ID
- Open nephrectomies
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.
PubMed 23860059Bravi CA, Larcher A, Capitanio U, Mari A, Antonelli A, Artibani W, Barale M, Bertini R, Bove P, Brunocilla E, Da Pozzo L, Di Maida F, Fiori C, Gontero P, Li Marzi V, Longo N, Mirone V, Montanari E, Porpiglia F, Schiavina R, Schips L, Simeone C, Siracusano S, Terrone C, Trombetta C, Volpe A, Montorsi F, Ficarra V, Carini M, Minervini A. Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project). Eur Urol Focus. 2021 Mar;7(2):390-396. doi: 10.1016/j.euf.2019.10.013. Epub 2019 Nov 12.
PubMed 31727523Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.
PubMed 18945716Capdevila X, Moulard S, Plasse C, Peshaud JL, Molinari N, Dadure C, Bringuier S. Effectiveness of Epidural Analgesia, Continuous Surgical Site Analgesia, and Patient-Controlled Analgesic Morphine for Postoperative Pain Management and Hyperalgesia, Rehabilitation, and Health-Related Quality of Life After Open Nephrectomy: A Prospective, Randomized, Controlled Study. Anesth Analg. 2017 Jan;124(1):336-345. doi: 10.1213/ANE.0000000000001688.
PubMed 27918333Elsharkawy 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 30688787Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.
PubMed 17116561Wilkinson KM, Krige A, Brearley SG, Lane S, Scott M, Gordon AC, Carlson GL. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial. Trials. 2014 Oct 21;15:400. doi: 10.1186/1745-6215-15-400.
PubMed 25336055Dua A, Hendrix JM. Quadratus Lumborum Block. 2026 Jun 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
PubMed 30725897
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Versus Quadratus Lamborum Block for Postoperative Analgesia in Adult Open Nephrectomies : A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT05174364
- Acronym / sponsor ID
- Open nephrectomies
- Conditions
- Post Operative Analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 30 Dec 2021 (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.
Our primary objective is to compare the effectiveness of bilateral QLB and epidural analgesia for postoperative management using VAS measured in PACU until 24 hours after surgery in patients undergoing elective open nephrectomies under GA. The secondary outcomes include: The 1st time to rescue analgesia and total amount of opioid consumption throughout the first postoperative day. hemodynamic variables. Any complications as postoperative nausea and vomiting (PONV) and sedation. The sensory block coverage \& the Bromage score at 2, 6, 12, and 24 hours after anesthesia recovery and duration of urinary catheter usage. Duration of PACU stay and postoperative duration of hospitalization and Patients' satisfaction.
Detailed description
Open surgery remains basic surgery for patients requiring radical or partial nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. The physiopathology of acute pain is explained as it is mediated by inflammatory cell infiltration, activation of the pain pathways in the spinal cord, and reflexive muscle spasm. All these three mechanisms of acute pain are typically ameliorated during the postoperative recovery. Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction.
QLB has been introduced as a component of multimodal analgesia for thoracic and abdominal surgeries as:
cesarean section, hip arthroplasty, inguinal hernia repair and nephrectomies. It provides a great spread of local anesthesia which allows anesthesia from T6 - L2 and provides loss of somatic and visceral pain. The QLB was initially described by R.Blanco where the local anesthetic (LA) was injected at the anterolateral aspect of the QL muscle (type 1 QLB). Later, J.
Børglum used the posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type 3 QLB). Recently, R. Blanco described another approach by injecting the LA at the posterior aspect of the QL muscle (type 2 QLB), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is less. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle. QLBs may be particularly useful in nephrectomy as it lacks the adverse effects associated with patient controlled analgesia including nausea, vomiting, sedation, and respiratory depression, as well as side effects of patient controlled epidural analgesia such as pruritus hypotension, and urinary retention. Our hypothesis is that performing ultrasound guided QLB will be more superior or equal to epidural block in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Block | – | –Epidural block for the control group will be done before induction of general anesthesia. Patients will be positioned in the sitting position, an 18-gauge Tuohy needle will be inserted into epidural space of Th 11-12 intervertebral space under aseptic condition. In the medial approach, the site of the insertion of the needle is between the spaces created by the vertebral spinous processes. Upon locating the desired spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle |
| Quadratus Lumborum Block | – | –Bilateral QL block type 3 (anterior) for the intervention group will be performed on both sides of the patient after induction of general anesthesia. Patient will be positioned in semi-lateral decubitus and using low-frequency ultrasonography (USG) guidance attached to inferior lumbar region (Petit's triangle) that is consisted of inferior iliac crest and bordered by two muscles such as latissimus dorsi muscle in the posterior, abdominal external oblique muscle in the anterior. The USG will display the Shamrock sign, where the transverse process of vertebrae L4 role as the trunk, erector spinae muscle on the posterior side, psoas major (PM) on the anterior side, and QL muscle on the lateral side. After the visualization of QL and PM muscles, the Contiplex R needle will be directed parallel to the posterior side of the ultrasound probe until the tip of needle is confirmed in the border of QL and PM muscle |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Any patient fulfilling the inclusion criteria participating in our study .
Key inclusion criteria (4 listed)
- Patients of American Society of Anesthesiologists (ASA) class I or II physical status.
- Age:20-60 years old.
- Patients scheduled for open nephrectomies .
- Gender: both
Key exclusion criteria (8 listed)
- Patient refusal.
- Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- Morbid obesity (BMI >35).
- Patient with known hypersensitivity to amide local anesthetics or morphine.
- Patient with any contraindication for intrathecal anesthesia, e.g. coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
compare the effectiveness of bilateral QLB and epidural analgesia
Time frame: 24 hours
postoperative pain management using visual analog scale measured in postanesthesia care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 23860059Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.
- Background: PubMed 31727523Bravi CA, Larcher A, Capitanio U, Mari A, Antonelli A, Artibani W, Barale M, Bertini R, Bove P, Brunocilla E, Da Pozzo L, Di Maida F, Fiori C, Gontero P, Li Marzi V, Longo N, Mirone V, Montanari E, Porpiglia F, Schiavina R, Schips L, Simeone C, Siracusano S, Terrone C, Trombetta C, Volpe A, Montorsi F, Ficarra V, Carini M, Minervini A. Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project). Eur Urol Focus. 2021 Mar;7(2):390-396. doi: 10.1016/j.euf.2019.10.013. Epub 2019 Nov 12.
- Background: PubMed 18945716Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.
- Background: PubMed 27918333Capdevila X, Moulard S, Plasse C, Peshaud JL, Molinari N, Dadure C, Bringuier S. Effectiveness of Epidural Analgesia, Continuous Surgical Site Analgesia, and Patient-Controlled Analgesic Morphine for Postoperative Pain Management and Hyperalgesia, Rehabilitation, and Health-Related Quality of Life After Open Nephrectomy: A Prospective, Randomized, Controlled Study. Anesth Analg. 2017 Jan;124(1):336-345. doi: 10.1213/ANE.0000000000001688.
- 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 17116561Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.
- Background: PubMed 25336055Wilkinson KM, Krige A, Brearley SG, Lane S, Scott M, Gordon AC, Carlson GL. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial. Trials. 2014 Oct 21;15:400. doi: 10.1186/1745-6215-15-400.
- Background: PubMed 30725897Dua A, Hendrix JM. Quadratus Lumborum Block. 2026 Jun 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
Related trials for Post Operative Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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.
Kelani A. Abd El-Salam, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Analgesia, run by Assiut University.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah A. Bastawy, resident (00201121409356, sarahbastawy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the effectiveness of bilateral QLB and epidural analgesia (time frame: 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 NCT05174364, which also lists 8 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 Jan 2022.