Post Operative Pain ManagementNCT06670508
Efficacy of Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy
A study testing Subcostal Transversus Abdominis Plane block and Erector Spinae Plane block in people with Post Operative Pain Management, run by Cairo University at 1 site in Egypt.
Trial summary
The investigators hypothesize that erector spinae plane block is better than subcostal transversus abdominis plane block regarding postoperative pain management. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain Management
- What is being tested?
- Subcostal Transversus Abdominis Plane block and Erector Spinae Plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 15 May 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
- Patient age (>18 and <60)
- Both sexes
- American Society of Anesthesiologists (ASA) physical status classes I and II
- Patients scheduled for total (radical) laparoscopic nephrectomy surgery
Who cannot join
- Refusal of regional block
- Patients with uncontrolled diabetes or hypertension
- Patients with neurological, psychological disorders or those lacking cooperation
- Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL)
- Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
- Patients who are allergic to amide local anesthetics.
- Cases converted to open surgery will also be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy: A Randomized Clinical Trial
The investigators hypothesize that erector spinae plane block is better than subcostal transversus abdominis plane block regarding postoperative pain management.
Read the detailed description
Aim of the work:
The purpose of this study is to compare erector spinae plane block to subcostal transversus abdominis plane block in laparoscopic nephrectomy regarding analgesic efficacy and postoperative morphine consumption.
Statistical Analysis
- Sample size:
Sample size was calculated using G-power software. A previous study (Hosgood et al., Transplantation 2012; 94: 520-525) reported that the amount of morphine used in the first 6 hours in patients received TAP block in nephrectomy was 12.4 ± 8.4. Assuming that the amount will change by 50% at least with the other block, a power of 80% and an alpha error of 0.05, the minimum sample size required will be 60 patients (30 in each group). We will increase it to 35 in each group to compensate for drop-outs.
II. Statistical analysis:
All measurement indexes will be expressed as mean ± SD/standard error of the mean or number (%). After analysis of normality of data distribution, normally distributed data will be compared by the independent sample t-test. Unpaired quantitative variables will be evaluated by the Student t-test and analysis of variance. The Mann-Whitney U test will be employed for intergroup comparison, and the Wilcoxon signed-rank test for comparison between different time points within the same group. Intergroup comparison of categorical variables will be performed by the chi-square test. Values of A P value less than 0.05 will be considered statistically significant. All data will be statistically analyzed by statisticians using the SPSS v28 software package (IBM Corp., Armonk, NY, USA).
- Conditions
- Post Operative Pain Management
- Being tested
- Subcostal Transversus Abdominis Plane block, Erector Spinae Plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal Transversus Abdominis Plane blockProcedure or surgery
Group A, The patient was in the supine position then; the Subcostal TAP block was given by a high frequency linear ultrasound transducer (Siemens acuson x300 3-5MHz ultrasound). After skin preparation and isolation, the transducer was placed 2 cm sub-xiphoid, then moved along the subcostal edge to identify the rectus abdominis muscle and the transversus abdominis then, a blunted tip, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) was introduced in-plane 2-3 cm lateral to the transducer, under direct ultrasound visualization. After confirming the correct placement of the needle and the negative aspiration probe, the rest of the anaesthetic substance was injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine on each side after aspiration to avoid intravascular placement, and the dissection of the plane was observed. The block was performed bilaterally.
Erector Spinae Plane blockProcedure or surgery
Group B, the patient was placed in the prone position. Then, the Erector Spinae block was given by same ultrasound transducer . It was sagittaly placed against the target vertebral level (T7 transverse process) in the prone position and moved in approximately 3-cm lateral to the spinous process.. The Erector Spinae muscle and transverse process was identified, and a same blunted tip , 20-gauge, short bevel needle was advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane. The block was performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the thoracic vertebrae laterally (specifically at T7).
| Study group | Role | What they receive |
|---|---|---|
| Subcostal TAP Block | Active comparator | Group A, The patient was in the supine position then; the Subcostal TAP block was given by a high frequency linear ultrasound transducer (Siemens acuson x300 3-5MHz ultrasound). After skin preparation and isolation, the transducer was placed 2 cm sub-xiphoid, then moved along the subcostal edge to identify the rectus abdominis muscle and the transversus abdominis then, a blunted tip, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) was introduced in-plane 2-3 cm lateral to the transducer, under direct ultrasound visualization. After confirming the correct placement of the needle and the negative aspiration probe, the rest of the anaesthetic substance was injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine on each side after aspiration to avoid intravascular placement, and the dissection of the plane was observed. The block was performed bilaterally. Receives: Procedure: Subcostal Transversus Abdominis Plane block |
| ESP Block | Active comparator | Group B, the patient was placed in the prone position. Then, the Erector Spinae block was given by same ultrasound transducer . It was sagittaly placed against the target vertebral level (T7 transverse process) in the prone position and moved in approximately 3-cm lateral to the spinous process.. The Erector Spinae muscle and transverse process was identified, and a same blunted tip , 20-gauge, short bevel needle was advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane. The block was performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the thoracic vertebrae laterally (specifically at T7). Receives: Procedure: Erector Spinae Plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine consumption at 6 hours postoperatively (co-primary endpoint)
Total cumulative morphine consumption (in milligrams) measured at 6 hours postoperatively. Co-primary endpoint with 24-hour cumulative morphine consumption.
Measured: From end of surgery to 6 hours postoperatively
Cumulative morphine consumption at 24 hours postoperatively (co-primary endpoint)
Total cumulative morphine consumption (in milligrams) measured at 24 hours postoperatively. Co-primary endpoint with 6-hour cumulative morphine consumption.
Measured: From end of surgery to 24 hours postoperatively
Secondary outcomes (8)
Failure rate in both groups
Failure rate in both groups
Measured: in first hour postoperatively
Time taken to perform a successful block
Time taken to perform a successful block
Measured: 30 minutes from time just after local anesthetic injection to successful site of incisions and dermatomal coverage
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting
Measured: Immediately post operative for 24 hours
Time to ambulate in both groups
Time to ambulate in both groups
Measured: Immediate 24 hours post-operative
p/f ratio postoperatively in both groups
p/f ratio postoperatively in both groups
Measured: after first 12, 24 hours postoperatively
Incidence of postoperative pulmonary complication
Incidence of postoperative pulmonary complication
Measured: chest x-ray Immediate 24 hours post-operative
Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block
Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block
Measured: Immediate 24 hours post-operative
Time for first rescue analgesia in each block
Time for first rescue analgesia in each block
Measured: Immediate 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Oct 2023
- Primary completion31 Mar 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Youssef, Cairo University
- Investigators
- Mohamed A Ollaek, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670508
- Sponsor's protocol ID
- MS-95-2023
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ollaek M, Aboudorra O, Goma H, Taha A, Bakr H. The Efficacy of Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy: A Randomized Clinical Trial. Clin J Pain. 2026 Oct 1;42(10):e1401. doi: 10.1097/AJP.0000000000001401.
PubMed 42145106
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06670508
- Acronym / sponsor ID
- MS-95-2023
- Conditions
- Post Operative Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 1 Nov 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.
The investigators hypothesize that erector spinae plane block is better than subcostal transversus abdominis plane block regarding postoperative pain management.
Detailed description
Aim of the work:
The purpose of this study is to compare erector spinae plane block to subcostal transversus abdominis plane block in laparoscopic nephrectomy regarding analgesic efficacy and postoperative morphine consumption.
Statistical Analysis
- Sample size:
Sample size was calculated using G-power software. A previous study (Hosgood et al., Transplantation 2012; 94: 520-525) reported that the amount of morphine used in the first 6 hours in patients received TAP block in nephrectomy was 12.4 ± 8.4. Assuming that the amount will change by 50% at least with the other block, a power of 80% and an alpha error of 0.05, the minimum sample size required will be 60 patients (30 in each group). We will increase it to 35 in each group to compensate for drop-outs.
II. Statistical analysis:
All measurement indexes will be expressed as mean ± SD/standard error of the mean or number (%). After analysis of normality of data distribution, normally distributed data will be compared by the independent sample t-test. Unpaired quantitative variables will be evaluated by the Student t-test and analysis of variance. The Mann-Whitney U test will be employed for intergroup comparison, and the Wilcoxon signed-rank test for comparison between different time points within the same group. Intergroup comparison of categorical variables will be performed by the chi-square test. Values of A P value less than 0.05 will be considered statistically significant. All data will be statistically analyzed by statisticians using the SPSS v28 software package (IBM Corp., Armonk, NY, USA).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcostal TAP Block | Active comparator | Procedure: Subcostal Transversus Abdominis Plane blockGroup A, The patient was in the supine position then; the Subcostal TAP block was given by a high frequency linear ultrasound transducer (Siemens acuson x300 3-5MHz ultrasound). After skin preparation and isolation, the transducer was placed 2 cm sub-xiphoid, then moved along the subcostal edge to identify the rectus abdominis muscle and the transversus abdominis then, a blunted tip, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) was introduced in-plane 2-3 cm lateral to the transducer, under direct ultrasound visualization. After confirming the correct placement of the needle and the negative aspiration probe, the rest of the anaesthetic substance was injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine on each side after aspiration to avoid intravascular placement, and the dissection of the plane was observed. The block was performed bilaterally. |
| ESP Block | Active comparator | Procedure: Erector Spinae Plane blockGroup B, the patient was placed in the prone position. Then, the Erector Spinae block was given by same ultrasound transducer . It was sagittaly placed against the target vertebral level (T7 transverse process) in the prone position and moved in approximately 3-cm lateral to the spinous process.. The Erector Spinae muscle and transverse process was identified, and a same blunted tip , 20-gauge, short bevel needle was advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane. The block was performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the thoracic vertebrae laterally (specifically at T7). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient age (>18 and <60)
- Both sexes
- American Society of Anesthesiologists (ASA) physical status classes I and II
- Patients scheduled for total (radical) laparoscopic nephrectomy surgery
Key exclusion criteria (8 listed)
- Refusal of regional block
- Patients with uncontrolled diabetes or hypertension
- Patients with neurological, psychological disorders or those lacking cooperation
- Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL)
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 |
|---|---|---|
| Subcostal Transversus Abdominis Plane blockGroup A, The patient was in the supine position then; the Subcostal TAP block was given by a high frequency linear ultrasound transducer (Siemens acuson x300 3-5MHz ultrasound). After skin preparation and isolation, the transducer was placed 2 cm sub-xiphoid, then moved along the subcostal edge to identify the rectus abdominis muscle and the transversus abdominis then, a blunted tip, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) was introduced in-plane 2-3 cm lateral to the transducer, under direct ultrasound visualization. After confirming the correct placement of the needle and the negative aspiration probe, the rest of the anaesthetic substance was injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine on each side after aspiration to avoid intravascular placement, and the dissection of the plane was observed. The block was performed bilaterally. | Procedure or surgery | Subcostal TAP Block |
| Erector Spinae Plane blockGroup B, the patient was placed in the prone position. Then, the Erector Spinae block was given by same ultrasound transducer . It was sagittaly placed against the target vertebral level (T7 transverse process) in the prone position and moved in approximately 3-cm lateral to the spinous process.. The Erector Spinae muscle and transverse process was identified, and a same blunted tip , 20-gauge, short bevel needle was advanced, using the in-plane approach, in cephalad-to-caudal direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane. The block was performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the thoracic vertebrae laterally (specifically at T7). | Procedure or surgery | ESP Block |
Primary outcome
Cumulative morphine consumption at 6 hours postoperatively (co-primary endpoint)
Time frame: From end of surgery to 6 hours postoperatively
Total cumulative morphine consumption (in milligrams) measured at 6 hours postoperatively. Co-primary endpoint with 24-hour cumulative morphine consumption.
Cumulative morphine consumption at 24 hours postoperatively (co-primary endpoint)
Time frame: From end of surgery to 24 hours postoperatively
Total cumulative morphine consumption (in milligrams) measured at 24 hours postoperatively. Co-primary endpoint with 6-hour cumulative morphine consumption.
8 secondary outcomes
Failure rate in both groups
Time frame: in first hour postoperatively
Time taken to perform a successful block
Time frame: 30 minutes from time just after local anesthetic injection to successful site of incisions and dermatomal coverage
Postoperative nausea and vomiting
Time frame: Immediately post operative for 24 hours
Time to ambulate in both groups
Time frame: Immediate 24 hours post-operative
p/f ratio postoperatively in both groups
Time frame: after first 12, 24 hours postoperatively
Incidence of postoperative pulmonary complication
Time frame: chest x-ray Immediate 24 hours post-operative
Incidence of complications (hematoma at the site of injection and local anesthetic toxicity) related to each block
Time frame: Immediate 24 hours post-operative
Time for first rescue analgesia in each block
Time frame: Immediate 24 hours post-operative
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 1 May 2026.
- Derived from this study: PubMed 42145106Ollaek M, Aboudorra O, Goma H, Taha A, Bakr H. The Efficacy of Erector Spinae Plane Block Versus Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy: A Randomized Clinical Trial. Clin J Pain. 2026 Oct 1;42(10):e1401. doi: 10.1097/AJP.0000000000001401.
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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.
Mohamed A Ollaek, MD principal investigator
Cairo 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 Subcostal Transversus Abdominis Plane block and Erector Spinae Plane block in people with Post Operative Pain Management, run by Cairo 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 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: finished, as of the sponsor's last update on 1 May 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?
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?
Cumulative morphine consumption at 6 hours postoperatively (co-primary endpoint) (time frame: From end of surgery to 6 hours postoperatively). 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?
On the ClinicalTrials.gov record for NCT06670508, which also lists 1 linked publication.
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 1 May 2026.