- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131985
Analgesic Efficacy of Erector Spinae Plane Block for Laparoscopic Inguinal Hernia Repair
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- university of health siences diskapi yildirim beyazit T&R hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Erector spina block
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). All anesthesia procedure will be the same as control group |
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).
|
NO_INTERVENTION: Control
There were no intervention.
All patients will receive pre-oxygenation with O2 100% for 3 min.
Anesthesia will be induced by using fentanyl 1-2μg/kg, propofol 2 - 4 mg/kg and rocuronium 0.6 mg/kg will be used for muscle relaxation.
Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCO2≈ 35-40 mmHg.
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.
Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria.Tramadol 100 mg i.v. will be used before 15 min end of surgery and 20 mL of 25% bupivacaine will be infiltrated to the trochar sites at the end of the surgery.
Patient control analgesia device will administer all patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of postoperative pain
Time Frame: 1hour
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
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1hour
|
The degree of postoperative pain
Time Frame: 6 hours after operation
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
|
6 hours after operation
|
The degree of postoperative pain
Time Frame: 12 hours after operation
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
|
12 hours after operation
|
The degree of postoperative pain
Time Frame: 24 hours after operation
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
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24 hours after operation
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The degree of postoperative pain
Time Frame: 0 hour after operation in postanesthesia care unit
|
The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
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0 hour after operation in postanesthesia care unit
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The degree of postoperative pain
Time Frame: 4 hours after operation
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The degree of pain will be measured with numerical rating scale (NRS).
All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
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4 hours after operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects of opioid usage
Time Frame: 1, 6, 12 and 24 hours after operation
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Any evidence of opioid-related morbidity or adverse effects eg.
nausea,vomiting,pruritus.These effects will be assessed by questionnaire as yes or no
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1, 6, 12 and 24 hours after operation
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Sensory block levels
Time Frame: 1, 6, 12 and 24 hours after operation
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Sensory block will evaluate by cold stimulus (0 = no cold sensation, 1 = cold sensation severely reduced, 2 = cold sensation slightly decreased, 3 = normal cold sensation)
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1, 6, 12 and 24 hours after operation
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Postoperative tramadol consumption
Time Frame: The first 24 hour after operation
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total tramadol consumption in both groups will be assessed in the postoperative period
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The first 24 hour after operation
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Postoperative quality of recovery
Time Frame: One day before surgery in outpatient clinics of anesthesiology, at 6 hours after the operation, and 24 hours after operation
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The quality of postoperative functional recovery was assessed using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items).
Each item was rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time.
The total score ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery)
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One day before surgery in outpatient clinics of anesthesiology, at 6 hours after the operation, and 24 hours after operation
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Collaborators and Investigators
Investigators
- Principal Investigator: Savas Altinsoy, MD, Diskapi Yildirim Beyazit Education and Research Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lap ing Hernia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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