The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia After Inguinal Hernia Repair
Condition: Postoperative Pain; Inguinal Hernia; Acute Pain
MeSH terms: Pain, Postoperative; Hernia; Acute Pain; Hernia, Inguinal
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): ESP Block; Global Quality of Recovery-15 score; Standard Pain Followup and Monitorization
Intervention type(s): Procedure; Other; Other
Intervention description(s): 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; Global Quality of Recovery-15 score (QoR-15) will be recorded prior to the surgery and at the postoperative 24th hour.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: erector spinae plane block; inguinal hernia; interfascial plane; postoperative pain