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

NCT07509957 | Completed

• 1 other identifier: HRÜ/26.01.49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperatively and 24 hours after surgery

Secondary Outcomes (6)

• Postoperative Acute Pain Scores

  15 minutes, 30 minutes, 60 minutes, and 120 minutes, as well as 6 hours, 12 hours, and 24 hours after surgery

• Total Opioid Consumption

  Within the first 24 hours after surgery

• Time to return to daily activities

  30 days after surgery

• Duration of spinal anesthesia

  From intrathecal injection to regression of sensory block within the first 24 hours after surgery

• Motor block level assessed using the Bromage Scale

  During the intraoperative period and within the first 24 hours after surgery

Study Arms (2)

ESPB Group

EXPERIMENTAL

Patients will receive ultrasound-guided erector spinae plane block (ESPB) after surgery in addition to standard analgesia.

Procedure: Erector Spinae Plane Block (ESPB) group

Control Group

NO INTERVENTION

Patients will receive standard postoperative analgesia without any regional block.

Interventions

Erector Spinae Plane Block (ESPB) group PROCEDURE

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.

ESPB Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

Study Sites (2)

Sanliurfa Education and Research Hospital

Sanliurfa, Eyyübiye, 63040, Turkey (Türkiye)

Location

Muğla Training and Research Hospital

Menteşe, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 40285488 BACKGROUND

• Tsai 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.

  PMID: 41180512 BACKGROUND

• Sakae 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.

  PMID: 34118259 BACKGROUND

• Tolver 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.

  PMID: 22014375 BACKGROUND

• Bakota 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.

  PMID: 26381501 BACKGROUND

• Kulacoglu H, Alptekin A. Current options in local anesthesia for groin hernia repairs. Acta Chir Iugosl. 2011;58(3):25-35. doi: 10.2298/aci1103025k.

  PMID: 22369015 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Tolga Karaçay

  Sanliurfa Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 3, 2026
• Study Start: April 4, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 16, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)