Erector Spinae Plane BlockanalgesiaNCT07251400
Analgesic Efficacy of Erector Spinae and Rectus Sheath Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair
A study testing Erector spinae plane block in people with Erector Spinae Plane Block and Laparoscopic Inguinal Hernia Repair, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Erector Spinae Plane Block, Laparoscopic Inguinal Hernia Repair
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 30 Jun 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and under 70 years of age
- ASA I-III
Who cannot join
- Patients with ASA IV,
- known neurological or psychiatric disorders,
- asthma or COPD,
- long-term drug or alcohol abuse,
- diabetes mellitus,
- BMI >35,
Show all 10Show fewer
- intellectual disability,
- contraindications for EPSP or RSB,
- massive bleeding, coagulopathy
- those with significant systemic conditions undergoing emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, Umraniye, 34034
About this study
Official title: The Analgesic Efficacy of Ultrasound-guided Erector Spinae and Rectus Sheath Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial
The aim of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair.
Read the detailed description
Multiple factors play a critical role in the development of pain after laparoscopic bilateral inguinal hernia repair surgery. These include parietal stimulation from the surgical incision, visceral stimulation from the peritoneum, and manipulation of intra-abdominal structures. Somatic innervation of the anterior abdominal wall is provided by the thoracolumbar spinal nerves T6-L1. Innervation of the skin above the umbilicus is provided by cutaneous nerves T6 to T9. The area around the umbilicus is innervated by T10, while the underlying skin is innervated by T11, T12, and L1. The peritoneum contains "silent nociceptors" that are activated by surgical injury and intraperitoneal inflammation and contribute to visceral pain. The neuro-immuno-humoral pain pathways involved in abdominal surgery involve somatic and autonomic nerves. Parasympathetic activation and decreased vagal tone have been shown to influence perioperative outcome because they exacerbate inflammation associated with gastrointestinal dysfunction. Thoracic epidural analgesia is still considered the gold standard for postoperative analgesia in major abdominal surgery; however, concerns about the risk of major complications such as hypotension, motor block, epidural hematoma, and abscess sometimes limit its use. Intravenous morphine administration is a cornerstone of pain management, but the side effects seen after opioid use limit its use. An ideal multimodal analgesic method includes regional blocks (neuraxial blocks [epidural and paravertebral analgesia], plane blocks [transversus abdominis plane blocks and rectus sheath block], intravenous analgesic medications (nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 selective inhibitors, or single intraoperative dexamethasone), and surgical field infiltration.
Erector spinae plane block (ESPB) was first described for the treatment of thoracic neuropathic pain and has since become an effective periparavertebral regional anesthesia technique applied to prevent postoperative pain in various surgeries. ESPB was initially applied at the T5 level, but more recently has been shown to be effective in providing comprehensive somatic and visceral abdominal analgesia when applied at the T7-T9 level. It is easier to administer than thoracic epidural anesthesia and thoracic paravertebral block. The effectiveness of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy has been studied. A study evaluating ESPB with bilateral ultrasound concluded that it provides effective analgesia in patients and significantly reduces analgesia requirements, extending to up to 1 week. Bilateral rectus sheath block (RSB) provides analgesia to the anteromedial abdominal wall and periumbilical area by blocking spinal dermatomes T9, T10, and T11. RSB provides analgesia to the anterior cutaneous branches of the intercostal nerves and is therefore well-suited for postoperative analgesia for midline abdominal incisions. Although initially developed to provide anterior abdominal muscle relaxation, RSB has subsequently been used for pain relief after abdominal surgery. This fascial plane block involves the deposition of a local anesthetic between the rectus muscle and the posterior sheath to anesthetize the terminal branches of the lower thoracic spinal nerves T7-T12. A recent meta-analysis of 698 patients found that RSB improved pain control and reduced opioid consumption for up to 12 hours postoperatively, with no significant adverse events reported.
The primary objective of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair. The secondary objective was to compare opioid consumption in the postoperative period.
- Being tested
- Erector spinae plane block
- Keywords
- postoperative analgesia, erector spinae plane block, inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Also called Bilateral rectus sheath block
postoperative analgesia for inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| ESB (Erector spinae plane block) group | Active comparator | The ESP block will be applied under general anesthesia after skin closure lateral decubitus position. The ultrasound probe will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the T7 spinous process. Using the inplane technique, a 22-gauge, 80 mm needle will be advanced craniocaudally, and 30 ml of 0.25% bupivacaine will be injected between the erector spinae muscle and the transverse process. ESPB will be performed bilaterally, with 30 ml of local anesthetic administered to the plane of the erector spinae on each side. Receives: Procedure: Erector spinae plane block |
| RSB (Bilateral rectus sheath block) group | Active comparator | Before recovery from anesthesia, an ultrasound-guided rectus sheath block will be performed after the skin incision is closed. the rectus sheath and the posterior aspect of the rectus abdominis muscle an 80 mm, 22-gauge short-tapered needle will be advanced anterolaterally to medially using in-plane placement with real-time assessment, Once the tip is correctly positioned in the intended plane, 20 mL of a local anesthetic, typically bupivacaine at a concentration of 0.25%, will be administered on each side for effective analgesia. Receives: Procedure: Erector spinae plane block |
| LA infiltration group | Active comparator | Patients who will receive local anesthesia only for surgical incisions will be considered the control group. 20 ml of 0.25% bupivacaine will be applied to the surgical incisions, and no plane block will be performed Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain in patients undergoing laparoscopic bilateral hernia repair
VAS score
Measured: 24 hours after extubation
Secondary outcomes (1)
Total Postoperative Opioid Consumption
remifentanyl
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Oct 2025
- Primary completion28 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies 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
- * Group 1: ESB (n = 30) * Group 2: RSB (n = 30) * Group 3: LA infiltration (n = 30)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
- Investigators
- Zeliha Alıcıkuş, asc prof, Principal investigator, Umraniye ERH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251400
- Sponsor's protocol ID
- Zeliha20
- Acronym
- analgesia
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Ultrasound-guided Erector Spinae and Rectus Sheath Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07251400
- Acronym / sponsor ID
- analgesia / Zeliha20
- Keywords
- postoperative analgesia, erector spinae plane block, inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 26 Nov 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 aim of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair.
Detailed description
Multiple factors play a critical role in the development of pain after laparoscopic bilateral inguinal hernia repair surgery. These include parietal stimulation from the surgical incision, visceral stimulation from the peritoneum, and manipulation of intra-abdominal structures. Somatic innervation of the anterior abdominal wall is provided by the thoracolumbar spinal nerves T6-L1. Innervation of the skin above the umbilicus is provided by cutaneous nerves T6 to T9. The area around the umbilicus is innervated by T10, while the underlying skin is innervated by T11, T12, and L1. The peritoneum contains "silent nociceptors" that are activated by surgical injury and intraperitoneal inflammation and contribute to visceral pain. The neuro-immuno-humoral pain pathways involved in abdominal surgery involve somatic and autonomic nerves. Parasympathetic activation and decreased vagal tone have been shown to influence perioperative outcome because they exacerbate inflammation associated with gastrointestinal dysfunction. Thoracic epidural analgesia is still considered the gold standard for postoperative analgesia in major abdominal surgery; however, concerns about the risk of major complications such as hypotension, motor block, epidural hematoma, and abscess sometimes limit its use. Intravenous morphine administration is a cornerstone of pain management, but the side effects seen after opioid use limit its use. An ideal multimodal analgesic method includes regional blocks (neuraxial blocks [epidural and paravertebral analgesia], plane blocks [transversus abdominis plane blocks and rectus sheath block], intravenous analgesic medications (nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 selective inhibitors, or single intraoperative dexamethasone), and surgical field infiltration.
Erector spinae plane block (ESPB) was first described for the treatment of thoracic neuropathic pain and has since become an effective periparavertebral regional anesthesia technique applied to prevent postoperative pain in various surgeries. ESPB was initially applied at the T5 level, but more recently has been shown to be effective in providing comprehensive somatic and visceral abdominal analgesia when applied at the T7-T9 level. It is easier to administer than thoracic epidural anesthesia and thoracic paravertebral block. The effectiveness of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy has been studied. A study evaluating ESPB with bilateral ultrasound concluded that it provides effective analgesia in patients and significantly reduces analgesia requirements, extending to up to 1 week. Bilateral rectus sheath block (RSB) provides analgesia to the anteromedial abdominal wall and periumbilical area by blocking spinal dermatomes T9, T10, and T11. RSB provides analgesia to the anterior cutaneous branches of the intercostal nerves and is therefore well-suited for postoperative analgesia for midline abdominal incisions. Although initially developed to provide anterior abdominal muscle relaxation, RSB has subsequently been used for pain relief after abdominal surgery. This fascial plane block involves the deposition of a local anesthetic between the rectus muscle and the posterior sheath to anesthetize the terminal branches of the lower thoracic spinal nerves T7-T12. A recent meta-analysis of 698 patients found that RSB improved pain control and reduced opioid consumption for up to 12 hours postoperatively, with no significant adverse events reported.
The primary objective of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair. The secondary objective was to compare opioid consumption in the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- * Group 1: ESB (n = 30) * Group 2: RSB (n = 30) * Group 3: LA infiltration (n = 30)
| Arm | Type | Receives |
|---|---|---|
| ESB (Erector spinae plane block) group | Active comparator | Procedure: Erector spinae plane blockThe ESP block will be applied under general anesthesia after skin closure lateral decubitus position. The ultrasound probe will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the T7 spinous process. Using the inplane technique, a 22-gauge, 80 mm needle will be advanced craniocaudally, and 30 ml of 0.25% bupivacaine will be injected between the erector spinae muscle and the transverse process. ESPB will be performed bilaterally, with 30 ml of local anesthetic administered to the plane of the erector spinae on each side. |
| RSB (Bilateral rectus sheath block) group | Active comparator | Procedure: Erector spinae plane blockBefore recovery from anesthesia, an ultrasound-guided rectus sheath block will be performed after the skin incision is closed. the rectus sheath and the posterior aspect of the rectus abdominis muscle an 80 mm, 22-gauge short-tapered needle will be advanced anterolaterally to medially using in-plane placement with real-time assessment, Once the tip is correctly positioned in the intended plane, 20 mL of a local anesthetic, typically bupivacaine at a concentration of 0.25%, will be administered on each side for effective analgesia. |
| LA infiltration group | Active comparator | Procedure: Erector spinae plane blockPatients who will receive local anesthesia only for surgical incisions will be considered the control group. 20 ml of 0.25% bupivacaine will be applied to the surgical incisions, and no plane block will be performed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 and under 70 years of age
- ASA I-III
Key exclusion criteria (10 listed)
- Patients with ASA IV,
- known neurological or psychiatric disorders,
- asthma or COPD,
- long-term drug or alcohol abuse,
- diabetes mellitus,
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 blockAlso: Bilateral rectus sheath blockpostoperative analgesia for inguinal hernia repair | Procedure or surgery | ESB (Erector spinae plane block) group, LA infiltration group, RSB (Bilateral rectus sheath block) group |
Primary outcome
postoperative pain in patients undergoing laparoscopic bilateral hernia repair
Time frame: 24 hours after extubation
VAS score
1 secondary outcome
Total Postoperative Opioid Consumption
Time frame: immediately after the surgery
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 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Zeliha Alıcıkuş, asc prof principal investigator
Umraniye ERH
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 in people with Erector Spinae Plane Block and Laparoscopic Inguinal Hernia Repair, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 6 Oct 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 Turkey (Türkiye). 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?
postoperative pain in patients undergoing laparoscopic bilateral hernia repair (time frame: 24 hours after extubation). 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 Oct 2026.