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

Başak Altıparmak

Status: Completed

Conditions: Postoperative Pain; Acute Pain; Inguinal Hernia

Treatments: Other: Standard Pain Followup and Monitorization; Procedure: ESP Block; Other: Global Quality of Recovery-15 score

Study type: Interventional

Funder types: Other

Identifiers

NCT04300153

20-II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 2 patient groups

ESP Group

Experimental group

Description:

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.

Treatment:

Other: Standard Pain Followup and Monitorization

Other: Global Quality of Recovery-15 score

Procedure: ESP Block

Control Group

Sham Comparator group

Description:

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.

Treatment:

Other: Standard Pain Followup and Monitorization

Other: Global Quality of Recovery-15 score

Procedure: ESP Block