Inguinal Hernia UnilateralESPB for IHRNCT07509957
Effect of Preoperative Erector Spinae Plane Block on Recovery Quality, Time to Return to Daily Activities, and Postoperative Pain Scores in Inguinal Hernia Surgery
A study testing Erector Spinae Plane Block (ESPB) group in people with Inguinal Hernia Unilateral and Erector Spinae Plane Block, run by Sanliurfa Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of the erector spinae plane block (ESPB), performed after surgery, on quality of recovery, postoperative pain, and time to return to daily activities in patients undergoing open inguinal hernia repair under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia Unilateral, Erector Spinae Plane Block, Quality of Recovery (QoR-15)
- What is being tested?
- Erector Spinae Plane Block (ESPB) group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Apr 2026to 16 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- Patients scheduled to undergo open IHT surgery under spinal anesthesia (unilateral)
- Both male and female patients
Who cannot join
- Patients with coagulation disorders
- Patients with chronic opioid use
- Patients who develop intraoperative complications
- Patients with a preoperative Numeric Rating Scale (NRS) pain score ≥4
- Patients with a history of revision (recurrent) surgery
- Patients unable to communicate for any reason
- Patients who decline to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Muğla Training and Research Hospital
Menteşe, Muğla, 48000
Sanliurfa Education and Research Hospital
Sanliurfa, Eyyübiye, 63040
About this study
This study aims to evaluate the effect of the erector spinae plane block (ESPB), performed after surgery, on quality of recovery, postoperative pain, and time to return to daily activities in patients undergoing open inguinal hernia repair under spinal anesthesia.
Postoperative pain following inguinal hernia surgery may delay recovery and negatively affect patients' return to normal daily life. Although ESPB has been widely used as an effective analgesic technique in various surgical procedures, its effectiveness in inguinal hernia repair remains limited and not well established.
Read more
In this randomized controlled study, patients will be divided into two groups: one group will receive ESPB after surgery, while the control group will not receive any block. All patients will receive standard postoperative analgesia.
Quality of recovery, acute pain scores, and analgesic consumption will be assessed within the first 24 hours after surgery, and return to daily activities will be evaluated 30 days after surgery.
The primary outcome of this study is quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery. Scores will be recorded preoperatively and 24 hours after surgery.
Secondary outcomes include postoperative pain intensity, total opioid consumption, and time to return to daily activities. Pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, at 15, 30, 60, and 120 minutes, as well as 6, 12, and 24 hours after surgery.
Total opioid consumption will be determined by recording the cumulative dose of intravenous tramadol administered as rescue analgesia within the first 24 hours after surgery. Time to return to daily activities will be evaluated via telephone follow-up 15 days after surgery.
Read the detailed description
This prospective, randomized, controlled study is designed to evaluate the effect of erector spinae plane block (ESPB) on postoperative recovery in patients undergoing open inguinal hernia repair under spinal anesthesia.
After obtaining written informed consent, eligible patients aged 18-65 years will be enrolled. Standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation, will be applied upon arrival in the operating room. An intravenous line will be established, and isotonic saline infusion (15 mL/kg/h) will be initiated. Sedation will be provided with intravenous midazolam (0.03 mg/kg).
Spinal anesthesia will be performed at the L3-L4 interspace using 13 mg hyperbaric bupivacaine combined with 15 µg fentanyl.
At the end of surgery, patients will be randomized into two groups using a computer-generated randomization list prepared by an independent statistician. Group allocation will be concealed in sealed opaque envelopes and revealed to the anesthesiologist performing the intervention.
In the ESPB group, an ultrasound-guided erector spinae plane block will be performed at the T11-T12 level on the side of surgery. Patients will be positioned in the lateral decubitus position. After sterile preparation, a 2-5 MHz convex ultrasound probe (Fujifilm Sonosite, USA) will be placed in a paramedian sagittal orientation and then shifted laterally to visualize the transverse process and erector spinae muscle. A 22-gauge, 100-mm needle will be advanced using an in-plane technique, and 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the transverse process and erector spinae muscle.
Patients in the control group will not receive any regional block.
All patients will receive a standardized postoperative analgesic regimen consisting of intravenous dexketoprofen (50 mg every 6 hours). Rescue analgesia will be provided with intravenous tramadol (1 mg/kg) if the Numeric Rating Scale (NRS) score is ≥4.
Postoperative monitoring will be conducted in the recovery unit and surgical ward according to institutional protocols. Clinical data, including spinal anesthesia parameters such as block duration, motor block level, and sensory block level, will be recorded.
Follow-up assessments will be performed within the first 24 hours after surgery and via telephone contact 30 days after surgery to evaluate functional recovery.
- Conditions
- Inguinal Hernia Unilateral, Erector Spinae Plane Block, Quality of Recovery (QoR-15), Numeric Rating Scale, Return to Daily Activity
- Being tested
- Erector Spinae Plane Block (ESPB) group
- Keywords
- Inguinal Hernia Repair, Erector Spinae Plane Block, Regionel Anesthesia, Quality of Recovery, Return to Daily Activity, Postoperative Pain
- 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) groupProcedure or surgery
Ultrasound-guided erector spinae plane block will be performed at the T11-T12 level using 30 mL of 0.25% bupivacaine at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| ESPB Group | Experimental | Patients will receive ultrasound-guided erector spinae plane block (ESPB) after surgery in addition to standard analgesia. Receives: Procedure: Erector Spinae Plane Block (ESPB) group |
| Control Group | No intervention | Patients will receive standard postoperative analgesia without any regional block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
The Quality of Recovery-15 (QoR-15) is a validated questionnaire assessing postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
Measured: Preoperatively and 24 hours after surgery
Secondary outcomes (6)
Postoperative Acute Pain Scores
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: 15 minutes, 30 minutes, 60 minutes, and 120 minutes, as well as 6 hours, 12 hours, and 24 hours after surgery
Total Opioid Consumption
Total opioid consumption will be calculated based on the cumulative dose of intravenous tramadol administered as rescue analgesia during the first 24 hours postoperatively.
Measured: Within the first 24 hours after surgery
Time to return to daily activities
Time to return to daily activities will be evaluated through a telephone follow-up conducted on postoperative day 30. Return to daily life was defined as the time point at which patients were able to perform basic daily activities independently without significant limitation due to postoperative pain, regardless of return to work.
Measured: 30 days after surgery
Duration of spinal anesthesia
Duration of spinal anesthesia will be defined as the time from intrathecal injection to regression of sensory block.
Measured: From intrathecal injection to regression of sensory block within the first 24 hours after surgery
Motor block level assessed using the Bromage Scale
Motor block will be assessed using the Bromage Scale, which ranges from 0 to 3, where higher scores indicate a greater degree of motor blockade.
Measured: During the intraoperative period and within the first 24 hours after surgery
Sensory block level (dermatome level)
Sensory block level will be assessed by determining the highest dermatome level of sensory blockade using standard clinical methods.
Measured: During the intraoperative period and within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start4 Apr 2026
- Primary completion1 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia UnilateralStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tolga Karaçay, Sanliurfa Education and Research Hospital
- Investigators
- Tolga Karaçay, Principal investigator, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509957
- Sponsor's protocol ID
- HRÜ/26.01.49
- Acronym
- ESPB for IHR
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliveira CNB, Graziani E Sousa A, Balthazar da Silveira CA, Kasakewitch JPG, Camacho D, Malcher F, Lima DL. The Analgesic Impact of Erector Spinae Plane Block in Inguinal Hernia Repair: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Laparoendosc Adv Surg Tech A. 2025 Jun;35(6):445-450. doi: 10.1089/lap.2025.0020. Epub 2025 Apr 26.
PubMed 40285488Tsai VFS, Tai TE, Tsai YC. Effect of early return to work after laparoscopic total extraperitoneal hernia repair: A retrospective comparative cohort study. Tzu Chi Med J. 2025 Jul 23;37(4):418-423. doi: 10.4103/tcmj.tcmj_287_24. eCollection 2025 Oct-Dec.
PubMed 41180512Sakae TM, Mattiazzi APF, Fiorentin JZ, Brandao J, Benedetti RH, Takaschima AKK. Ultrasound-guided erector spinae plane block for open inguinal hernia repair: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):49-54. doi: 10.1016/j.bjane.2021.04.032. Epub 2021 Jun 9.
PubMed 34118259Tolver MA, Strandfelt P, Forsberg G, Hjorne FP, Rosenberg J, Bisgaard T. Determinants of a short convalescence after laparoscopic transabdominal preperitoneal inguinal hernia repair. Surgery. 2012 Apr;151(4):556-63. doi: 10.1016/j.surg.2011.08.020. Epub 2011 Oct 19.
PubMed 22014375Bakota B, Kopljar M, Baranovic S, Miletic M, Marinovic M, Vidovic D. Should we abandon regional anesthesia in open inguinal hernia repair in adults? Eur J Med Res. 2015 Sep 17;20(1):76. doi: 10.1186/s40001-015-0170-0.
PubMed 26381501Kulacoglu H, Alptekin A. Current options in local anesthesia for groin hernia repairs. Acta Chir Iugosl. 2011;58(3):25-35. doi: 10.2298/aci1103025k.
PubMed 22369015
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Erector Spinae Plane Block on Recovery Quality, Time to Return to Daily Activities, and Postoperative Pain Scores in Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT07509957
- Acronym / sponsor ID
- ESPB for IHR / HRÜ/26.01.49
- Conditions
- Inguinal Hernia Unilateral, Erector Spinae Plane Block, Quality of Recovery (QoR-15), Numeric Rating Scale, Return to Daily Activity
- Keywords
- Inguinal Hernia Repair, Erector Spinae Plane Block, Regionel Anesthesia, Quality of Recovery, Return to Daily Activity, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 3 Apr 2026 (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.
This study aims to evaluate the effect of the erector spinae plane block (ESPB), performed after surgery, on quality of recovery, postoperative pain, and time to return to daily activities in patients undergoing open inguinal hernia repair under spinal anesthesia.
Postoperative pain following inguinal hernia surgery may delay recovery and negatively affect patients' return to normal daily life. Although ESPB has been widely used as an effective analgesic technique in various surgical procedures, its effectiveness in inguinal hernia repair remains limited and not well established.
In this randomized controlled study, patients will be divided into two groups: one group will receive ESPB after surgery, while the control group will not receive any block. All patients will receive standard postoperative analgesia.
Quality of recovery, acute pain scores, and analgesic consumption will be assessed within the first 24 hours after surgery, and return to daily activities will be evaluated 30 days after surgery.
The primary outcome of this study is quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery. Scores will be recorded preoperatively and 24 hours after surgery.
Secondary outcomes include postoperative pain intensity, total opioid consumption, and time to return to daily activities. Pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, at 15, 30, 60, and 120 minutes, as well as 6, 12, and 24 hours after surgery.
Total opioid consumption will be determined by recording the cumulative dose of intravenous tramadol administered as rescue analgesia within the first 24 hours after surgery. Time to return to daily activities will be evaluated via telephone follow-up 15 days after surgery.
Detailed description
This prospective, randomized, controlled study is designed to evaluate the effect of erector spinae plane block (ESPB) on postoperative recovery in patients undergoing open inguinal hernia repair under spinal anesthesia.
After obtaining written informed consent, eligible patients aged 18-65 years will be enrolled. Standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation, will be applied upon arrival in the operating room. An intravenous line will be established, and isotonic saline infusion (15 mL/kg/h) will be initiated. Sedation will be provided with intravenous midazolam (0.03 mg/kg).
Spinal anesthesia will be performed at the L3-L4 interspace using 13 mg hyperbaric bupivacaine combined with 15 µg fentanyl.
At the end of surgery, patients will be randomized into two groups using a computer-generated randomization list prepared by an independent statistician. Group allocation will be concealed in sealed opaque envelopes and revealed to the anesthesiologist performing the intervention.
In the ESPB group, an ultrasound-guided erector spinae plane block will be performed at the T11-T12 level on the side of surgery. Patients will be positioned in the lateral decubitus position. After sterile preparation, a 2-5 MHz convex ultrasound probe (Fujifilm Sonosite, USA) will be placed in a paramedian sagittal orientation and then shifted laterally to visualize the transverse process and erector spinae muscle. A 22-gauge, 100-mm needle will be advanced using an in-plane technique, and 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the transverse process and erector spinae muscle.
Patients in the control group will not receive any regional block.
All patients will receive a standardized postoperative analgesic regimen consisting of intravenous dexketoprofen (50 mg every 6 hours). Rescue analgesia will be provided with intravenous tramadol (1 mg/kg) if the Numeric Rating Scale (NRS) score is ≥4.
Postoperative monitoring will be conducted in the recovery unit and surgical ward according to institutional protocols. Clinical data, including spinal anesthesia parameters such as block duration, motor block level, and sensory block level, will be recorded.
Follow-up assessments will be performed within the first 24 hours after surgery and via telephone contact 30 days after surgery to evaluate functional recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB Group | Experimental | Procedure: Erector Spinae Plane Block (ESPB) groupPatients will receive ultrasound-guided erector spinae plane block (ESPB) after surgery in addition to standard analgesia. |
| Control Group | No intervention | –Patients will receive standard postoperative analgesia without any regional block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years
- Patients scheduled to undergo open IHT surgery under spinal anesthesia (unilateral)
- Both male and female patients
Key exclusion criteria (7 listed)
- Patients with coagulation disorders
- Patients with chronic opioid use
- Patients who develop intraoperative complications
- Patients with a preoperative Numeric Rating Scale (NRS) pain score ≥4
- Patients with a history of revision (recurrent) surgery
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) groupUltrasound-guided erector spinae plane block will be performed at the T11-T12 level using 30 mL of 0.25% bupivacaine at the end of surgery. | Procedure or surgery | ESPB Group |
Primary outcome
Quality of Recovery
Time frame: Preoperatively and 24 hours after surgery
The Quality of Recovery-15 (QoR-15) is a validated questionnaire assessing postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
6 secondary outcomes
Postoperative Acute Pain Scores
Time frame: 15 minutes, 30 minutes, 60 minutes, and 120 minutes, as well as 6 hours, 12 hours, and 24 hours after surgery
Total Opioid Consumption
Time frame: Within the first 24 hours after surgery
Time to return to daily activities
Time frame: 30 days after surgery
Duration of spinal anesthesia
Time frame: From intrathecal injection to regression of sensory block within the first 24 hours after surgery
Motor block level assessed using the Bromage Scale
Time frame: During the intraoperative period and within the first 24 hours after surgery
Sensory block level (dermatome level)
Time frame: During the intraoperative period and within the first 24 hours after 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 17 Jul 2026.
- Background: PubMed 40285488Oliveira CNB, Graziani E Sousa A, Balthazar da Silveira CA, Kasakewitch JPG, Camacho D, Malcher F, Lima DL. The Analgesic Impact of Erector Spinae Plane Block in Inguinal Hernia Repair: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Laparoendosc Adv Surg Tech A. 2025 Jun;35(6):445-450. doi: 10.1089/lap.2025.0020. Epub 2025 Apr 26.
- Background: PubMed 41180512Tsai VFS, Tai TE, Tsai YC. Effect of early return to work after laparoscopic total extraperitoneal hernia repair: A retrospective comparative cohort study. Tzu Chi Med J. 2025 Jul 23;37(4):418-423. doi: 10.4103/tcmj.tcmj_287_24. eCollection 2025 Oct-Dec.
- Background: PubMed 34118259Sakae TM, Mattiazzi APF, Fiorentin JZ, Brandao J, Benedetti RH, Takaschima AKK. Ultrasound-guided erector spinae plane block for open inguinal hernia repair: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):49-54. doi: 10.1016/j.bjane.2021.04.032. Epub 2021 Jun 9.
- Background: PubMed 22014375Tolver MA, Strandfelt P, Forsberg G, Hjorne FP, Rosenberg J, Bisgaard T. Determinants of a short convalescence after laparoscopic transabdominal preperitoneal inguinal hernia repair. Surgery. 2012 Apr;151(4):556-63. doi: 10.1016/j.surg.2011.08.020. Epub 2011 Oct 19.
- Background: PubMed 26381501Bakota B, Kopljar M, Baranovic S, Miletic M, Marinovic M, Vidovic D. Should we abandon regional anesthesia in open inguinal hernia repair in adults? Eur J Med Res. 2015 Sep 17;20(1):76. doi: 10.1186/s40001-015-0170-0.
- Background: PubMed 22369015Kulacoglu H, Alptekin A. Current options in local anesthesia for groin hernia repairs. Acta Chir Iugosl. 2011;58(3):25-35. doi: 10.2298/aci1103025k.
- 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.
Tolga Karaçay principal investigator
Sanliurfa Education and Research Hospital
2 sites 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) group in people with Inguinal Hernia Unilateral and Erector Spinae Plane Block, run by Sanliurfa Education and Research Hospital at 2 sites 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 3 inclusion and 7 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quality of Recovery (time frame: Preoperatively and 24 hours after surgery). 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 NCT07509957, which also lists 6 linked publications.
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 17 Jul 2026.