Erector Spinae Plane Block, Inguinal Hernia Unilateral, Numeric Rating Scale, Quality of Recovery (QoR-15), Return to Daily Activity
Conditions
Keywords
Inguinal Hernia Repair, Erector Spinae Plane Block, Regionel Anesthesia, Quality of Recovery, Return to Daily Activity, Postoperative Pain
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.
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.
Interventions
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.
Sponsors
Sanliurfa Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. |
| Total Opioid Consumption | 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. |
| Time to return to daily activities | 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. |
| Duration of spinal anesthesia | 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. |
| Motor block level assessed using the Bromage Scale | 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. |
| Sensory block level (dermatome level) | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORTolga Karaçay
Sanliurfa Education and Research Hospital
Outcome results
None listed