Renal TransplantationNCT07749040
Comparison Between Ultrasound Guided Quadratus Lumborum Block and Erector Spinae Plane Block as an Analgesic Modality in Renal Transplant Donors
A study testing Renal transplantation in people with Renal Transplantation and Nerve Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
Open surgery remains one of the approaches used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain (Gupta et al., 2013; Bravi et al., 2019). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Transplantation, Nerve Block
- What is being tested?
- Renal transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be over age 21
- Be willing to commit to the pre-donation evaluation process, surgery and the burden of recovery.
- No psychological condition.
- Fulfilling criteria for renal donation
Who cannot join
- Are under age 21
- Denying participating in the study
- Not fulfilling criteria for renal donation
Trial locations and contacts
1 site in 1 country.
About this study
Open surgery remains one of the approaches used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain (Gupta et al., 2013; Bravi et al., 2019).
Erector Spinae Plane block (ESPB) has grown as a standard analgesic approach for thoracic, abdominal, and extremities surgeries because of its speed, ease of execution, minimal risk of hypotension and safety for patients with coagulopathy. Although it is believed that the spinal neurons' ventral and dorsal rami are involved, the exact pathway is yet uncertain (Forero et al., 2016; Hamed et al., 2019).
Read the detailed description
Regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction (Capdevila et al., 2017).
Erector Spinae Plane block (ESPB), was initially described by Forero et al. (2016) for analgesia in thoracic neuropathic pain (Forero et al., 2016) and despite its recent literature it has also been widely used in both adults and children at deferent levels for deferent indications such as chronic shoulder pain (T2), thoracic surgery and breast surgery (T4-5) and upper abdominal surgery (T7-8) (Chin et al., 2017a; Chin et al., 2017b), however, most of the published trials regarding its analgesic effect following major open abdominal surgeries are case reports and rare. In this ultrasound-guided (USG) approach, a local anesthetic (LA) is injected between the erector spinae muscle and the trans-verse process of the thoracic vertebrae leading to spread of LA cephalad, caudally and through the paravertebral space (Forero et al., 2016; Chin et al., 2017a; Chin et al., 2017b).
Quadratus Lumborum block (QLB) is a widely used as regional anesthesia technique as well. It has been used for reducing postoperative pain after cesarean section, laparotomy or laparoscopic procedure and hip surgery (Blanco et al., 2016; McCrum et al., 2018) it was defined for the first time by Blanco 2007 where the LA was injected at the anterolateral aspect of the QL muscle (type I QLB) (Blanco, 2007) Later, Børglum et al. (2013) used posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type III QLB) (Børglum et al., 2013).
Blanco and McDonnell, described another approach by injecting the LA at the posterior aspect of the QL muscle (type II QLB) (Blanco and McDonnell, 2013). Finally, the intramuscular QLB (type IV QLB) was performed by injecting LA directly into the QL muscle.
Hence, this study is designed to assess the efficacy of Quadratus lumborum block in comparison with erector spinae plane block in reducing post-operative pain and additional opioid requirement within the first 24 h in patients undergoing open nephrectomy under general anaesthesia.
- Conditions
- Renal Transplantation, Nerve Block
- Being tested
- Renal transplantation
- Keywords
- Quadratus lumborum nerve block, Erector spinae nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal transplantationProcedure or surgery
Two types of nerve will be applied to assess pain after renal transplantation in donors
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum nerve block | Active comparator | QLB will be done for patients in the study group at the end of surgery , before recovery of the patient from anesthesia. All blocks will be performed by one anesthesiologist experienced in U/S block; the patient will be placed in the lateral decubitus position according to the selected site of surgical interven-tion. The low-frequency convex probe of Sonosite M Turbo ultrasonography (FUJIFILM Sonosite, Inc., 124 S. E. ABD ELLATIF AND S. M. ABDELNABY Bothell, WA, USA) will be positioned horizontally in the anterior axillary line halfway between the subcostal margin and iliac crest after sterilization of the skin and draping, to locate the triple abdominal muscle layers, then the probe will be relocated subsequently to the posterior axillary line until the quadratus lumborum muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body, With the psoas major muscle places anteriorly, the erector spinae muscle posteriorly Receives: Procedure: Renal transplantation |
| Erector spinae nerve block | Active comparator | • In ESPB group In the ESPB group the patient will be placed in the lateral decubitus position according to the selected site of surgical intervention. After sterilization and drapping of the skin of the upper back, counting down from seventh cervical vertebrae spine to identify the spine of the seventh thoracic vertebrae (T7). This will be related to the tip of the scapular spine. A high-frequency probe of Sonosite M Turbo ultrasonography (FUJIFILM sonosite, Inc., Bothell, WA, USA) will be placed across the T7 spine and the probe will be moved laterally to identify the trans-verse process of T7. Thereafter, the probe will be moved to a sagittal plane to visualize the erector spinae muscles lying underneath the trapezius muscle. A 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted medially inplane relative to the ultrasound probe and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle, 1 ml Receives: Procedure: Renal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first postoperative analgesia (the time from recovery to the first given dose of pethidine).
Measured: 24 hours postoperative
Time to first postoperative analgesia
Time to first postoperative analgesia (the time from recovery to the first given dose of pethidine).
Measured: 24 hours postoperatively
Secondary outcomes (1)
VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749040
- Sponsor's protocol ID
- MD118/2024
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Quadratus Lumborum Block and Erector Spinae Plane Block as an Analgesic Modality in Renal Transplant Donors
- ClinicalTrials.gov ID
- NCT07749040
- Acronym / sponsor ID
- MD118/2024
- Conditions
- Renal Transplantation, Nerve Block
- Keywords
- Quadratus lumborum nerve block, Erector spinae nerve block
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Aug 2026 (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.
Open surgery remains one of the approaches used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain (Gupta et al., 2013; Bravi et al., 2019).
Erector Spinae Plane block (ESPB) has grown as a standard analgesic approach for thoracic, abdominal, and extremities surgeries because of its speed, ease of execution, minimal risk of hypotension and safety for patients with coagulopathy. Although it is believed that the spinal neurons' ventral and dorsal rami are involved, the exact pathway is yet uncertain (Forero et al., 2016; Hamed et al., 2019).
Detailed description
Regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction (Capdevila et al., 2017).
Erector Spinae Plane block (ESPB), was initially described by Forero et al. (2016) for analgesia in thoracic neuropathic pain (Forero et al., 2016) and despite its recent literature it has also been widely used in both adults and children at deferent levels for deferent indications such as chronic shoulder pain (T2), thoracic surgery and breast surgery (T4-5) and upper abdominal surgery (T7-8) (Chin et al., 2017a; Chin et al., 2017b), however, most of the published trials regarding its analgesic effect following major open abdominal surgeries are case reports and rare. In this ultrasound-guided (USG) approach, a local anesthetic (LA) is injected between the erector spinae muscle and the trans-verse process of the thoracic vertebrae leading to spread of LA cephalad, caudally and through the paravertebral space (Forero et al., 2016; Chin et al., 2017a; Chin et al., 2017b).
Quadratus Lumborum block (QLB) is a widely used as regional anesthesia technique as well. It has been used for reducing postoperative pain after cesarean section, laparotomy or laparoscopic procedure and hip surgery (Blanco et al., 2016; McCrum et al., 2018) it was defined for the first time by Blanco 2007 where the LA was injected at the anterolateral aspect of the QL muscle (type I QLB) (Blanco, 2007) Later, Børglum et al. (2013) used posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type III QLB) (Børglum et al., 2013).
Blanco and McDonnell, described another approach by injecting the LA at the posterior aspect of the QL muscle (type II QLB) (Blanco and McDonnell, 2013). Finally, the intramuscular QLB (type IV QLB) was performed by injecting LA directly into the QL muscle.
Hence, this study is designed to assess the efficacy of Quadratus lumborum block in comparison with erector spinae plane block in reducing post-operative pain and additional opioid requirement within the first 24 h in patients undergoing open nephrectomy under general anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum nerve block | Active comparator | Procedure: Renal transplantationQLB will be done for patients in the study group at the end of surgery , before recovery of the patient from anesthesia. All blocks will be performed by one anesthesiologist experienced in U/S block; the patient will be placed in the lateral decubitus position according to the selected site of surgical interven-tion. The low-frequency convex probe of Sonosite M Turbo ultrasonography (FUJIFILM Sonosite, Inc., 124 S. E. ABD ELLATIF AND S. M. ABDELNABY Bothell, WA, USA) will be positioned horizontally in the anterior axillary line halfway between the subcostal margin and iliac crest after sterilization of the skin and draping, to locate the triple abdominal muscle layers, then the probe will be relocated subsequently to the posterior axillary line until the quadratus lumborum muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body, With the psoas major muscle places anteriorly, the erector spinae muscle posteriorly |
| Erector spinae nerve block | Active comparator | Procedure: Renal transplantation• In ESPB group In the ESPB group the patient will be placed in the lateral decubitus position according to the selected site of surgical intervention. After sterilization and drapping of the skin of the upper back, counting down from seventh cervical vertebrae spine to identify the spine of the seventh thoracic vertebrae (T7). This will be related to the tip of the scapular spine. A high-frequency probe of Sonosite M Turbo ultrasonography (FUJIFILM sonosite, Inc., Bothell, WA, USA) will be placed across the T7 spine and the probe will be moved laterally to identify the trans-verse process of T7. Thereafter, the probe will be moved to a sagittal plane to visualize the erector spinae muscles lying underneath the trapezius muscle. A 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be inserted medially inplane relative to the ultrasound probe and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle, 1 ml |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
- Are under age 21
- Denying participating in the study
- Not fulfilling criteria for renal donation
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 |
|---|---|---|
| Renal transplantationTwo types of nerve will be applied to assess pain after renal transplantation in donors | Procedure or surgery | Erector spinae nerve block, Quadratus lumborum nerve block |
Primary outcome
Time to first postoperative analgesia (the time from recovery to the first given dose of pethidine).
Time frame: 24 hours postoperative
Time to first postoperative analgesia
Time frame: 24 hours postoperatively
Time to first postoperative analgesia (the time from recovery to the first given dose of pethidine).
1 secondary outcome
VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- 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.
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 Renal transplantation in people with Renal Transplantation and Nerve Block, 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 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 postoperative analgesia (the time from recovery to the first given dose of pethidine). (time frame: 24 hours postoperative). The study lists 2 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 6 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.