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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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 groups in NCT07251400
Study groupRoleWhat they receive
ESB (Erector spinae plane block) groupActive comparatorThe 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) groupActive comparatorBefore 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 groupActive comparatorPatients 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.

  1. postoperative pain in patients undergoing laparoscopic bilateral hernia repair

    VAS score

    Measured: 24 hours after extubation

Secondary outcomes (1)
  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.

  1. First posted26 Nov 2025
  2. Study start15 Oct 2025
  3. Primary completion28 May 2026
  4. Study completion30 Jun 2026

Resources

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)
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

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.

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