Postoperative Pain, AcuteNCT07113600
Erector Spinae Plane Block Versus Iliohypogastric/Ilioinguinal Nerve Block for Post-Hysterctomy Pain Relief
A study testing Nerve Block in people with Postoperative Pain, Acute, run by Kasr El Aini Hospital.
Trial summary
The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Nerve Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Oct 2025
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients above the age of 35 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
Who cannot join
- Patient refusal.
- History of allergy or intolerance to study medications.
- Chronic opioid use (>3 months).
- Severe renal or hepatic impairment.
- Patients with coagulopathy disorders.
- Infection at injection sites.
About this study
Official title: A Randomized Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Iliohypogastric/ Ilioinguinal Nerve Block for Postoperative Pain Relief in Female Patients Undergoing Open Hysterectomy
The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia.
One group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block).
The other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ).
Researchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.
Read the detailed description
The use of ultrasound for the placement of peripheral nerve blocks has received a great deal of attention in anesthesiology literature as well as clinical practice. Advantages of ultrasound-guided regional anesthesia include easy learning, fast onset, higher success rates, more complete blocks, using lower local anesthetic volumes and more safety. Good postoperative analgesia can prevent morbidity associated with abdominal hysterectomy by allowing pain-free, early ambulation and decreasing the risks of long hospital stay such as thrombo-embolism, and other poor outcomes. Truncal blocks such as transversus abdominis plane (TAP) blocks have seen limited success due to shorter duration and sub-optimal analgesia. The ultrasound (US)-guided erector spinae plane block (ESPB) w gained wide attention as a fast procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, is easy to perform, and requires less training. It provides extensive, potent unilateral analgesia, is performed by local anesthetic injection in the plane between the erector spinae muscle and the Transverse process of the corresponding vertebra. The local anesthetic diffuses into the para vertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of the thoracic spinal nerves. Bilateral ESPB performed at low thoracic levels was recently shown to provide satisfactory analgesia for gynecologic and abdominal surgery.
Abdominal field blocks, such as the ilio-inguinal / ilio-hypogastric (IL-IH) nerve block are well- known as simple ways to give long-lasting pain relief and limit narcotic usage after surgery.
The ilio-inguinal and ilio-hypogastric nerves are T 12 and L 1 branches that supply the inguinal region and run between the internal oblique and transversus abdominis muscles, slightly above the anterior superior iliac spine.
The aim of this study is to compare the analgesic effect of ilio-hypogastric / ilio-inguinal versus erector spine plane block on female patients undergoing open hysterectomy.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Nerve Block
- Keywords
- Humans, Female, Anesthesia, Conduction, Ultrasonography, Nerve Block, Pain, Postoperative, Ultrasonography, Interventional
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve BlockOther
Ilioinguinal/ Iliohypogastric nerve block:
In the supine position, the ultrasound probe probe is positioned in a transverse manner, superior to the anterior superior iliac spine. The three anterior abdominal muscle layers are identified, and the two nerves are identified in the abdominal neurovascular plane.
A echogenicneedle is inserted in a medial-to-lateral direction. After negative aspiration, 5 ml saline is injected to ensure correct needle tip position then 20 ml of bupivacaine 0.25% is injected gradually close to the nerves.
Erector spinae plane block:
In a lateral position, the erector spinae is visualized about 3 cm lateral to T7-T9 spinous processes on the target side. A echogenic needle (50 mm/22 gauge) is advanced in a cephalad to caudad direction until the tip reaches the plane deep to the erector spinae muscle immediately lateral to the transverse process. A 20 ml bupivacaine 0.25% is injected gradually into this plane.
| Study group | Role | What they receive |
|---|---|---|
| ESPB | Active comparator | Patients will receive bilateral Erector Spinae Plane block using 20ml bupivacaine 0.25% on each side. Receives: Other: Nerve Block |
| Ilioinguinal/iliohypogastric | Active comparator | Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20ml bupivacaine 0.25% on each side. Receives: Other: Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first call for analgesia.
The period of time starting from extubation until the patient asks for analgesia in hours.
Measured: The first 12 postoperative hours
Secondary outcomes (2)
postoperative pain score
Visual analog scale (0-100 mm)
Measured: VAS was assessed at 0, 2, 6, and 12 hours postoperatively.
intraoperative hemodynamic changes
Increase in heart rate(beat/min) or systolic blood pressure(mmHg) more than 20% of the baseline , hypotension (defined as a decrease in mean arterial pressure > 25% from the baseline value or systolic arterial pressure < 100 mmHg),
Measured: Operative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated with a 1:1 allocation ratio into two groups in a parallel manner: * Group A(n=29): Patients will receive bilateral ESP block using 20 ml bupivacaine 0.25% on each side. * Group B(n=29): Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20 ml bupivacaine 0.25% on each side.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ahmed Ali Mohamed El-sayed, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113600
- Sponsor's protocol ID
- N-119_2023/MSc
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Iliohypogastric/ Ilioinguinal Nerve Block for Postoperative Pain Relief in Female Patients Undergoing Open Hysterectomy
- ClinicalTrials.gov ID
- NCT07113600
- Acronym / sponsor ID
- N-119_2023/MSc
- Conditions
- Postoperative Pain, Acute
- Keywords
- Humans, Female, Anesthesia, Conduction, Ultrasonography, Nerve Block, Pain, Postoperative, Ultrasonography, Interventional
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 11 Aug 2025 (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 goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia.
One group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block).
The other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ).
Researchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.
Detailed description
The use of ultrasound for the placement of peripheral nerve blocks has received a great deal of attention in anesthesiology literature as well as clinical practice. Advantages of ultrasound-guided regional anesthesia include easy learning, fast onset, higher success rates, more complete blocks, using lower local anesthetic volumes and more safety. Good postoperative analgesia can prevent morbidity associated with abdominal hysterectomy by allowing pain-free, early ambulation and decreasing the risks of long hospital stay such as thrombo-embolism, and other poor outcomes. Truncal blocks such as transversus abdominis plane (TAP) blocks have seen limited success due to shorter duration and sub-optimal analgesia. The ultrasound (US)-guided erector spinae plane block (ESPB) w gained wide attention as a fast procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, is easy to perform, and requires less training. It provides extensive, potent unilateral analgesia, is performed by local anesthetic injection in the plane between the erector spinae muscle and the Transverse process of the corresponding vertebra. The local anesthetic diffuses into the para vertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of the thoracic spinal nerves. Bilateral ESPB performed at low thoracic levels was recently shown to provide satisfactory analgesia for gynecologic and abdominal surgery.
Abdominal field blocks, such as the ilio-inguinal / ilio-hypogastric (IL-IH) nerve block are well- known as simple ways to give long-lasting pain relief and limit narcotic usage after surgery.
The ilio-inguinal and ilio-hypogastric nerves are T 12 and L 1 branches that supply the inguinal region and run between the internal oblique and transversus abdominis muscles, slightly above the anterior superior iliac spine.
The aim of this study is to compare the analgesic effect of ilio-hypogastric / ilio-inguinal versus erector spine plane block on female patients undergoing open hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated with a 1:1 allocation ratio into two groups in a parallel manner: * Group A(n=29): Patients will receive bilateral ESP block using 20 ml bupivacaine 0.25% on each side. * Group B(n=29): Patients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20 ml bupivacaine 0.25% on each side.
| Arm | Type | Receives |
|---|---|---|
| ESPB | Active comparator | Other: Nerve BlockPatients will receive bilateral Erector Spinae Plane block using 20ml bupivacaine 0.25% on each side. |
| Ilioinguinal/iliohypogastric | Active comparator | Other: Nerve BlockPatients will receive bilateral Iliohypogastric and Ilioinguinal nerve block using 20ml bupivacaine 0.25% on each side. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult female patients above the age of 35 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria (6 listed)
- Patient refusal.
- History of allergy or intolerance to study medications.
- Chronic opioid use (>3 months).
- Severe renal or hepatic impairment.
- Patients with coagulopathy 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 |
|---|---|---|
| Nerve BlockIlioinguinal/ Iliohypogastric nerve block: In the supine position, the ultrasound probe probe is positioned in a transverse manner, superior to the anterior superior iliac spine. The three anterior abdominal muscle layers are identified, and the two nerves are identified in the abdominal neurovascular plane. A echogenicneedle is inserted in a medial-to-lateral direction. After negative aspiration, 5 ml saline is injected to ensure correct needle tip position then 20 ml of bupivacaine 0.25% is injected gradually close to the nerves. Erector spinae plane block: In a lateral position, the erector spinae is visualized about 3 cm lateral to T7-T9 spinous processes on the target side. A echogenic needle (50 mm/22 gauge) is advanced in a cephalad to caudad direction until the tip reaches the plane deep to the erector spinae muscle immediately lateral to the transverse process. A 20 ml bupivacaine 0.25% is injected gradually into this plane. | Other | ESPB, Ilioinguinal/iliohypogastric |
Primary outcome
The time to first call for analgesia.
Time frame: The first 12 postoperative hours
The period of time starting from extubation until the patient asks for analgesia in hours.
2 secondary outcomes
postoperative pain score
Time frame: VAS was assessed at 0, 2, 6, and 12 hours postoperatively.
intraoperative hemodynamic changes
Time frame: Operative time
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 11 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Block in people with Postoperative Pain, Acute, run by Kasr El Aini Hospital.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Aug 2025. 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?
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?
The time to first call for analgesia. (time frame: The first 12 postoperative hours). 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 11 Aug 2025.