Renal DiseaseNCT04361383
Erector Spinae Plane Versus Quadratus Lumborum Block for Patient Undergoing Open Nephrectomy
A study testing quadratus lumborum block type 3 and erector spinae plane block in people with Renal Disease, run by Zagazig University at 1 site in Egypt.
Trial summary
The postoperative pain after open nephrectomy remains a major concern because some patients still demonstrate acute pain that may develop chronic pain that lasts for months following the surgery. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Renal Disease
- What is being tested?
- quadratus lumborum block type 3 and erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2020to 1 Sep 2020
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient acceptance.
- BMI ≤ 30 kg/m2
- ASA II and III.
- Elective open nephrectomy under general anesthesia
Who cannot join
- History of allergy to the LA agents used in this study,
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Erector Spinae Plane Versus Quadratus Lumborum Block For Postoperative Analgesia for Patient Undergoing Open Nephrectomy: A Randomized Controlled Study.
The postoperative pain after open nephrectomy remains a major concern because some patients still demonstrate acute pain that may develop chronic pain that lasts for months following the surgery.
Epidural analgesia is the gold standard for abdominal surgery including for open nephrectomy, however, it has unfavorable side effects such as paresthesia, hypotension, hematomas, an impaired motor of lower limbs and urinary retention that could delay recovery.
Read more
Various techniques have tried to replicate the analgesic efficacy of epidural analgesia. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and transmuscular quadratus lumborum (TQL) analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries.
Up to the investigator's knowledge, there is no study done to compare ESPB versus QLB as pre-emptive analgesia in patients undergoing open nephrectomy.
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 [1]. 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 also reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery [2].
Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction [3].
Erector Spinae Plane block (RSPB), first described by Forero et al.,[4] for analgesia in thoracic neuropathic pain, has also been reported for the management of other causes of acute and postoperative pain [5,6,7]. In this ultrasound-guided (USG) technique, a local anesthetic (LA) is applied between the erector spinae muscle and the transverse process of the thoracic vertebra leading to the spread of LA cephalad, caudally and through the paravertebral space [4,5,8].
Quadratus Lumborum block (QLB) was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the LA was injected at the anterolateral aspect of the QL muscle (type 1 QLB) [9]. 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) [10]. 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 [11]. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle [12].
The investigators hypothesize that performing ultrasound-guided ESPB block will be more superior to or equal to QLB in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia.
- Conditions
- Renal Disease
- Being tested
- control group, quadratus lumborum block type 3, erector spinae plane block
- Keywords
- erector spinae plane block, ,Quadratus Lumborum block, open nephrectomy, analgesia
- Medical subject headings
- Kidney Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
the patient will receive general anesthesia
quadratus lumborum block type 3Procedure or surgery
Also called QLB
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
erector spinae plane blockProcedure or surgery
Also called ESPB
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | patients will be operated under general anesthesia. Receives: Other: control group |
| QLB group | Active comparator | patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia. Receives: Procedure: quadratus lumborum block type 3 |
| ESPB group | Active comparator | patients will receive ultrasound-guided erector spinae plane block with 30 ml of bupivacaine 0.25% followed by general anesthesia. Receives: Procedure: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 1st time to rescue analgesic
the time to ask for postoperative analgesia is the time from the end of operation to patient reporting VAS ≥ 3.
Measured: recorded within the first 24 hour postoperatively
Secondary outcomes (2)
Visual analogue scale (VAS)
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
Measured: measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively
Total dose of rescue analgesia (morphine)
once the VAS score will be ≥ 3, rescue analgesia in the form of 0.1 mg/kg morphine will be given and the total dose consumed will be recorded
Measured: in the first 24 hour postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start12 Apr 2020
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
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 Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361383
- Sponsor's protocol ID
- 6004-12-4-2020
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
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 23860059Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016McCrum CL, Ben-David B, Shin JJ, Wright VJ. Quadratus lumborum block provides improved immediate postoperative analgesia and decreased opioid use compared with a multimodal pain regimen following hip arthroscopy. J Hip Preserv Surg. 2018 Oct 25;5(3):233-239. doi: 10.1093/jhps/hny024. eCollection 2018 Aug.
PubMed 30393550Niraj G, Tariq Z. Continuous Erector Spinae Plane (ESP) Analgesia In Different Open Abdominal Surgical Procedures: A Case Series. (2018) J Anesth Surg 5(1): 57- 60.
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
PubMed 28272292
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Erector Spinae Plane Versus Quadratus Lumborum Block For Postoperative Analgesia for Patient Undergoing Open Nephrectomy: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04361383
- Acronym / sponsor ID
- 6004-12-4-2020
- Conditions
- Renal Disease
- Keywords
- erector spinae plane block, ,Quadratus Lumborum block, open nephrectomy, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 24 Apr 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.
The postoperative pain after open nephrectomy remains a major concern because some patients still demonstrate acute pain that may develop chronic pain that lasts for months following the surgery.
Epidural analgesia is the gold standard for abdominal surgery including for open nephrectomy, however, it has unfavorable side effects such as paresthesia, hypotension, hematomas, an impaired motor of lower limbs and urinary retention that could delay recovery.
Various techniques have tried to replicate the analgesic efficacy of epidural analgesia. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and transmuscular quadratus lumborum (TQL) analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries.
Up to the investigator's knowledge, there is no study done to compare ESPB versus QLB as pre-emptive analgesia in patients undergoing open nephrectomy.
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 [1]. 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 also reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery [2].
Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction [3].
Erector Spinae Plane block (RSPB), first described by Forero et al.,[4] for analgesia in thoracic neuropathic pain, has also been reported for the management of other causes of acute and postoperative pain [5,6,7]. In this ultrasound-guided (USG) technique, a local anesthetic (LA) is applied between the erector spinae muscle and the transverse process of the thoracic vertebra leading to the spread of LA cephalad, caudally and through the paravertebral space [4,5,8].
Quadratus Lumborum block (QLB) was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the LA was injected at the anterolateral aspect of the QL muscle (type 1 QLB) [9]. 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) [10]. 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 [11]. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle [12].
The investigators hypothesize that performing ultrasound-guided ESPB block will be more superior to or equal to QLB in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three equal groups
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: control grouppatients will be operated under general anesthesia. |
| QLB group | Active comparator | Procedure: quadratus lumborum block type 3patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia. |
| ESPB group | Active comparator | Procedure: erector spinae plane blockpatients will receive ultrasound-guided erector spinae plane block with 30 ml of bupivacaine 0.25% followed by general anesthesia. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient acceptance.
- BMI ≤ 30 kg/m2
- ASA II and III.
- Elective open nephrectomy under general anesthesia
Key exclusion criteria (3 listed)
- History of allergy to the LA agents used in this study,
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
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 |
|---|---|---|
| control groupthe patient will receive general anesthesia | Other | Control group |
| quadratus lumborum block type 3Also: QLBpatients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia. | Procedure or surgery | QLB group |
| erector spinae plane blockAlso: ESPBpatients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia. | Procedure or surgery | ESPB group |
Primary outcome
The 1st time to rescue analgesic
Time frame: recorded within the first 24 hour postoperatively
the time to ask for postoperative analgesia is the time from the end of operation to patient reporting VAS ≥ 3.
2 secondary outcomes
Visual analogue scale (VAS)
Time frame: measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively
Total dose of rescue analgesia (morphine)
Time frame: in the first 24 hour postoperatively.
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 21 Apr 2021.
- 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 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 30393550McCrum CL, Ben-David B, Shin JJ, Wright VJ. Quadratus lumborum block provides improved immediate postoperative analgesia and decreased opioid use compared with a multimodal pain regimen following hip arthroscopy. J Hip Preserv Surg. 2018 Oct 25;5(3):233-239. doi: 10.1093/jhps/hny024. eCollection 2018 Aug.
- BackgroundNiraj G, Tariq Z. Continuous Erector Spinae Plane (ESP) Analgesia In Different Open Abdominal Surgical Procedures: A Case Series. (2018) J Anesth Surg 5(1): 57- 60.
- Background: PubMed 28272292Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quadratus lumborum block type 3 and erector spinae plane block in people with Renal Disease, run by Zagazig 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 4 inclusion and 3 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 21 Apr 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. Some participants in this study may receive a placebo. 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?
The 1st time to rescue analgesic (time frame: recorded within the first 24 hour postoperatively). 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 NCT04361383, 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 21 Apr 2021.