Clinical trial NCT04300153: The Effect of Erector Spinae Plane Block on Quality of Recovery and Postoperative Analgesia After Inguinal Hernia Repair
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Inguinal Hernia
Acute Pain
Keywords: erector spinae plane block
inguinal hernia
interfascial plane
postoperative pain
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Muğla Sıtkı Koçman University
First posted: 2020-03-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Global Quality of Recovery-15 score
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 24 hours
measure: Rescue analgesia
timeFrame: 24 hours
measure: Mobilization time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman University
Study officials:
affiliation: Muğla Sıtkı Koçman University Medical Faculty
name: Başak Altıparmak
role: PRINCIPAL_INVESTIGATOR
References: