Post Operative PainNCT05179928
Erector Spinae Plane Block Versus Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery
A study testing Erector Spinae Plane Block (ESPB) and Rectus Sheath Block (RSB) in people with Post Operative Pain, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Erector Spinae Plane Block (ESPB) and Rectus Sheath Block (RSB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Mar 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Who cannot join
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
- Pregnant women
Show all 10Show fewer
- Allergy to study drugs
- Chronic pain
- Coagulation abnormalities or on anticoagulants
- Severe hepatic or kidney disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Damanhour Teaching Hospital
Damanhūr, El-Beheira
Ahmed M Shaat, MD, 00201223482709, ahmedshaat99@gmail.com
About this study
Official title: Is Erector Spinae Plane Block More Effective Than Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery in Adult Patients
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes.
Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses.
Read more
ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them.
Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.
- Conditions
- Post Operative Pain
- Being tested
- Erector Spinae Plane Block (ESPB), Rectus Sheath Block (RSB)
- Keywords
- Erector Spinae Plane Block, Rectus Sheath Block, Regional Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block (ESPB)Procedure or surgery
Postoperative Bilateral Ultrasound-guided ESPB
Rectus Sheath Block (RSB)Procedure or surgery
Postoperative Bilateral Ultrasound-guided RSB
| Study group | Role | What they receive |
|---|---|---|
| Group E (n=30) | Active comparator | Erector Spinae Plane Block Receives: Procedure: Erector Spinae Plane Block (ESPB) |
| Group R (n=30) | Active comparator | Rectus Sheath Block Receives: Procedure: Rectus Sheath Block (RSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
The time interval between the block performance and the first request of postoperative analgesia
Measured: 24 hours after block performance
Secondary outcomes (3)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (30 minutes, 1h, 6h, 12h, 18h, 24h) after block performance
Measured: 24 hours after block performance
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
The total dose of the rescue analgesic consumed in the first 24 hours after block performance
Measured: 24 hours after block performance
Number of participants and Rate of Postoperative Complications
Number of participants and Rate of: Nausea, Vomiting, Hematoma formation, Bowel perforation, and Pneumothorax
Measured: 24 hours after block performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Aug 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179928
- Sponsor's protocol ID
- DTH: 21004
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Erector Spinae Plane Block More Effective Than Rectus Sheath Block for Postoperative Analgesia After Supraumbilical Surgery in Adult Patients
- ClinicalTrials.gov ID
- NCT05179928
- Acronym / sponsor ID
- DTH: 21004
- Conditions
- Post Operative Pain
- Keywords
- Erector Spinae Plane Block, Rectus Sheath Block, Regional Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Jan 2022 (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.
Objectives: To compare the effectiveness of erector spinae plane block (ESPB) and rectus sheath block (RSB) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes.
Background: Supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. Because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. Previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses.
ESPB provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. RSB provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. The dermatomal distribution of ESPB and RSB makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them.
Patients and Methods: This was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group E; general anesthesia with postoperative bilateral ultrasound-guided ESPB, whereas in group R; general anesthesia with postoperative bilateral ultrasound-guided RSB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E (n=30) | Active comparator | Procedure: Erector Spinae Plane Block (ESPB)Erector Spinae Plane Block |
| Group R (n=30) | Active comparator | Procedure: Rectus Sheath Block (RSB)Rectus Sheath Block |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Key exclusion criteria (10 listed)
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 21 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
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 |
|---|---|---|
| Erector Spinae Plane Block (ESPB)Postoperative Bilateral Ultrasound-guided ESPB | Procedure or surgery | Group E (n=30) |
| Rectus Sheath Block (RSB)Postoperative Bilateral Ultrasound-guided RSB | Procedure or surgery | Group R (n=30) |
Primary outcome
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
Time frame: 24 hours after block performance
The time interval between the block performance and the first request of postoperative analgesia
3 secondary outcomes
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Time frame: 24 hours after block performance
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
Time frame: 24 hours after block performance
Number of participants and Rate of Postoperative Complications
Time frame: 24 hours after block performance
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 21 Sep 2026.
Related trials for Post Operative Pain
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Recruiting
Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Pain, Acute, Pain, Chronic
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.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block (ESPB) and Rectus Sheath Block (RSB) in people with Post Operative Pain, run by Damanhour Teaching 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Sep 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?
Contact Ahmed M Shaat, MD (00201223482709, ahmedshaat99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD) (time frame: 24 hours after block performance). 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 21 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.