The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia After Inguinal Hernia Repair

Study Overview
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Brief Summary
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Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Different pharmacological approaches and interfascial plane blocks are used to control postoperative pain. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was reported to be effective in different types of surgeries. In this study, the primary aim is to assess the effect of ESP on recovery of patients following open IHR surgery.

Detailed Description
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Inguinal hernia repair (IHR) is one of the most commonly performed operations in general surgery practice. Unfortunately, 40% of the patients experience moderate-to-severe acute pain in the early period. Erector spinae plane (ESP) block is a relatively new interfascial plane block which was described in 2016. In this prospective, controlled trial, the primary hypothesis is that ultrasound-guided unilateral ESP block will provide an increase in the quality of recovery-15 scores which will be assessed at the postoperative 24th hour following open IHR surgery. The secondary hypothesis is that ESP block will reduce postoperative pain scores, need for rescue analgesia and time to first mobilization.The study will be conducted as a single-center, prospective, randomized, controlled, double-blinded trial in a university hospital. Patients scheduled for an elective unilateral open IHR under spinal anesthesia, will be screened for enrollment to the study. At the end of the operation, patients will be randomized to receive a unilateral ESP block with 30 ml of 0.25% bupivacaine or 30 ml of normal saline at the level of T12 vertebrae. A blinded anesthesiologist will collect outcome measures in the postoperative period.

Official Title
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The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia of Patients Undergoing Inguinal Hernia Repair: Randomized, Controlled, Double Blinded Trial

Conditions
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Postoperative Pain, Inguinal Hernia, Acute Pain

Intervention / Treatment
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* Procedure: ESP Block
* Other: Global Quality of Recovery-15 score
* Other: Standard Pain Followup and Monitorization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status I-II Elective unilateral open inguinal hernia repair under spinal anesthesia Exclusion Criteria: Coagulation disorder Known allergy to study drugs Chronic opioid use Infection at the injection site Use of pain medications Psychologic disorder or inability to cooperate Quality of Recovery-15 (QoR-15) test Preoperative pain related to inguinal hernia NRS > 4/10

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP Group<br>At the end of the skin closure, patients will be positioned in lateral decubitis and unilateral ESP block will be performed with single injection of 30 ml 0.25% bupivacaine at the level of T12 transverse process. All patients will receive intravenous (iv) paracetamol 1000 mg at the arrival to the recovery room. The dosage will be repeated at every 8-hours interval. | Procedure: ESP Block<br>* At the end of the skin closure, patients will be positioned in lateral decubitis with the involved site lying superiorly. A convex ultrasound probe will be placed over the transverse process of T12 vertebra in longitudinal axis and an 80- mm 21-gauge needle will be inserted in the plane view under aseptic conditions. A unilateral ESP block will be performed with 30 ml 0.25% bupivacaine into the interfascial plane between erector spinae muscle and T12 transverse process<br>Other: Global Quality of Recovery-15 score<br>* Global Quality of Recovery-15 score (QoR-15) will be recorded prior to the surgery and at the postoperative 24th hour.<br>Other: Standard Pain Followup and Monitorization<br>* Numeric Rating Scale score will be recorded at the 1.-2.-4.-6.-8.-12.-24.hours. If Numerical Rating Scale score will be equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Numerical Rating Scale scores, the rescue analgesic need and the time for first mobilization of the patient will be recorded and kept in a statistical evaluation.<br>|
| Sham Comparator: Control Group<br>At the end of the skin closure, patients will be positioned in lateral decubitis and unilateral ESP block will be performed with single injection of 30 ml normal saline at the level of T12 transverse process. All patients will receive intravenous (iv) paracetamol 1000 mg at the arrival to the recovery room. The dosage will be repeated at every 8-hours interval. | Procedure: ESP Block<br>* At the end of the skin closure, patients will be positioned in lateral decubitis with the involved site lying superiorly. A convex ultrasound probe will be placed over the transverse process of T12 vertebra in longitudinal axis and an 80- mm 21-gauge needle will be inserted in the plane view under aseptic conditions. A unilateral ESP block will be performed with 30 ml 0.25% bupivacaine into the interfascial plane between erector spinae muscle and T12 transverse process<br>Other: Global Quality of Recovery-15 score<br>* Global Quality of Recovery-15 score (QoR-15) will be recorded prior to the surgery and at the postoperative 24th hour.<br>Other: Standard Pain Followup and Monitorization<br>* Numeric Rating Scale score will be recorded at the 1.-2.-4.-6.-8.-12.-24.hours. If Numerical Rating Scale score will be equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Numerical Rating Scale scores, the rescue analgesic need and the time for first mobilization of the patient will be recorded and kept in a statistical evaluation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Quality of Recovery-15 score | Global quality of recovery (QoR) score which will be measured by using 15-item QoR-15 questionnaire. This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item) | Postoperative 24th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (NRS) | A blinded anesthesiologist will assess postoperative pain of the patients during resting and movement at the 1st, 2nd, 4th, 6th, 8th, 12th and 24th hours by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable). | 24 hours | 
| Rescue analgesia | If Numerical Rating Scale score of the patient is equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Total rescue analgesia need will be recorded. | 24 hours | 
| Mobilization time | If the patient walks with or without help, it will be accepted as the first mobilization. The motor block duration and time for the first mobilization of the patient will be recorded. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae plane block, inguinal hernia, interfascial plane, postoperative pain