Clinical trial NCT04131985: Analgesic Efficacy of Erector Spinae Plane Block for Laparoscopic Inguinal Hernia Repair
Official title: Analgesic Efficacy of Erector Spinae Plane Block for Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Laparoscopic inguinal hernia surgery,
postoperative pain
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive erector spinae plane block, and the other will receive nothing
Primary purpose: PREVENTION

Brief summary: Postoperative analgesia management in inguinal hernia surgery is difficult because of the content of the surgical procedure. A multimodal approach to postoperative analgesia has recently been proposed. For this reason, various methods are used.Regional blocks, pharmacological treatments are among these methods. Among the regional blocks, ilioinguinal and hypogastric blocks are used more safely and with increasing frequency, especially with the introduction of ultrasonography in the clinic.Forero et al. firstly, erector spinae block which was used for the first time in the treatment of thoracic neuropathic pain has been widely used especially in laparoscopic abdominal surgery and it has taken its place in the literature. It is performed at T4-5 level in breast and thoracic surgery and T7 level in abdominal surgery. In this block, local anesthesia between the erector spina muscle and the transverse protrusion of the vertebra was used to create analgesia in the anterior abdominal wall.

In this study, we planned to investigate degree of postoperative pain, sensory block levels, analgesic consumption, propofol-remifentanyle consumption and side effects of patients undergoing inguinal hernia surgery under general anesthesia with erector spinae block.

Detailed description: Patients in the ASA 1-3 group who underwent laparoscopic inguinal hernia surgery, underwent erector spina block and operated under general anesthesia, will be included in the study. Approximately 50 patients will participate in the study, the number of patients will be finalized by power analysis.

The routine algorithm for patients undergoing elective laparoscopic inguinal hernia surgery is a multimodal approach including induction of general anesthesia for postoperative analgesia followed by peripheral nerve block and 50 mg of dexketoprofen trometamol. Before the block, all patients were monitored by standard monitoring and intravenous vascular access was opened. When applying the erector spinae block, the patient is placed in the lateral decubitus position. After the C7 spinous protrusion is prepared as sterile as T10, the erector spina muscle is seen at the T7 level on the same side as the hernia with the convex probe and block is applied with 0.25% bupivacaine (20 cc). In the control group, there were no intervention except local anesthetic infiltration to the trochar sites. Sensory block was evaluated by cold stimulus (0 = no cold sensation, 1 = cold sensation severely reduced, 2 = cold sensation slightly decreased, 3 = normal cold sensation). In anesthesia induction, propofol 2-4 mg / kg, fentanyl 1-2 mcq / kg, lidocaine 1mg / kg and rocuronium 0.6 mg / kg are routinely administered to all patients. Patients were treated with inhalation of oxygen and air mixture during surgery, and anesthesia was maintained using remifentanil 0.05-0.1 mcg/kg/min and propofol 80-100 mcg/kg/min via total intravenous micro pump until the surgery was completed. Postoperative analgesic needs of the patients will be recorded from the information in the current patient controlled analgesia device. All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded.

Eligibility criteria: Inclusion Criteria:

* Inguinal hernia disease

Exclusion Criteria:

* Cardio-respiratory disease
* Anti-inflammatory treatment
* Cognitive disorders
* Written consent form haven't get
* history of relevant drug allergy
* infection of the skin at the site of needle puncture area
* coagulopathy

Primary outcomes:
measure: The degree of postoperative pain
timeFrame: 1hour
measure: The degree of postoperative pain
timeFrame: 6 hours after operation
measure: The degree of postoperative pain
timeFrame: 12 hours after operation
measure: The degree of postoperative pain
timeFrame: 24 hours after operation
measure: The degree of postoperative pain
timeFrame: 0 hour after operation in postanesthesia care unit
measure: The degree of postoperative pain
timeFrame: 4 hours after operation
Secondary outcomes:
measure: Side effects of opioid usage
timeFrame: 1, 6, 12 and 24 hours after operation
measure: Sensory block levels
timeFrame: 1, 6, 12 and 24 hours after operation
measure: Postoperative tramadol consumption
timeFrame: The first 24 hour after operation
measure: Postoperative quality of recovery
timeFrame: One day before surgery in outpatient clinics of anesthesiology, at 6 hours after the operation, and 24 hours after operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: university of health siences diskapi yildirim beyazit T&R hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Savas Altinsoy, MD
role: PRINCIPAL_INVESTIGATOR
References: