Effect of Preoperative Erector Spinae Plane Block on Recovery Quality, Time to Return to Daily Activities, and Postoperative Pain Scores in Inguinal Hernia Surgery (ESPB for IHR)

April 4, 2026 updated by: Tolga Karaçay, Sanliurfa Education and Research Hospital

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 30 days after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Eyyübiye
      • Sanliurfa, Eyyübiye, Turkey (Türkiye), 63040
        • Recruiting
        • Sanliurfa Education and Research Hospital
        • Contact:
        • Principal Investigator:
          • Tolga Karaçay, M.D.
    • Muğla
      • Menteşe, Muğla, Turkey (Türkiye), 48000
        • Recruiting
        • Muğla Training and Research Hospital
        • Contact:
        • Sub-Investigator:
          • Başak Altıparmak, Prof.
        • Sub-Investigator:
          • Efsane Karcı Şınga, M.D.
        • Sub-Investigator:
          • Kaan Mircalı, M.D.
        • Sub-Investigator:
          • Melike Korkmaz Toker, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged between 18 and 65 years
  2. Patients scheduled to undergo open IHT surgery under spinal anesthesia (unilateral)
  3. Both male and female patients

Exclusion Criteria:

  1. Patients with coagulation disorders
  2. Patients with chronic opioid use
  3. Patients who develop intraoperative complications
  4. Patients with a preoperative Numeric Rating Scale (NRS) pain score ≥4
  5. Patients with a history of revision (recurrent) surgery
  6. Patients unable to communicate for any reason
  7. Patients who decline to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESPB Group
Patients will receive ultrasound-guided erector spinae plane block (ESPB) after surgery in addition to standard analgesia.
Procedure: Erector Spinae Plane Block (ESPB) group
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.
No Intervention: Control Group
Patients will receive standard postoperative analgesia without any regional block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
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
Total opioid consumption will be calculated based on the cumulative dose of intravenous tramadol administered as rescue analgesia during the first 24 hours postoperatively.
Within the first 24 hours after surgery
Time to return to daily activities
Time Frame: 30 days after surgery
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.
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
Duration of spinal anesthesia will be defined as the time from intrathecal injection to regression of sensory block.
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
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.
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
Sensory block level will be assessed by determining the highest dermatome level of sensory blockade using standard clinical methods.
During the intraoperative period and within the first 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Education and Research Hospital

Investigators

  • Principal Investigator: Tolga Karaçay, Sanliurfa Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRÜ/26.01.49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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