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Analgesic Efficacy of Erector Spinae Plane Block for Laparoscopic Inguinal Hernia Repair

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spina Block
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Laparoscopic inguinal hernia surgery,, postoperative pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • university of health siences diskapi yildirim beyazit T&R hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Erector spina block

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

The degree of postoperative pain
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.
The degree of postoperative pain
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.
The degree of postoperative pain
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.
The degree of postoperative pain
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.
The degree of postoperative pain
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.
The degree of postoperative pain
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.

Secondary Outcome Measures

Side effects of opioid usage
Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire as yes or no
Sensory block levels
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)
Postoperative tramadol consumption
total tramadol consumption in both groups will be assessed in the postoperative period
Postoperative quality of recovery
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)

Full Information

First Posted
October 15, 2019
Last Updated
November 27, 2020
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04131985
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Laparoscopic inguinal hernia surgery,, postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will receive erector spinae plane block, and the other will receive nothing
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector spina block
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector Spina Block
Intervention Description
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).
Primary Outcome Measure Information:
Title
The degree of postoperative pain
Description
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.
Time Frame
1hour
Title
The degree of postoperative pain
Description
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.
Time Frame
6 hours after operation
Title
The degree of postoperative pain
Description
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.
Time Frame
12 hours after operation
Title
The degree of postoperative pain
Description
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.
Time Frame
24 hours after operation
Title
The degree of postoperative pain
Description
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.
Time Frame
0 hour after operation in postanesthesia care unit
Title
The degree of postoperative pain
Description
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.
Time Frame
4 hours after operation
Secondary Outcome Measure Information:
Title
Side effects of opioid usage
Description
Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire as yes or no
Time Frame
1, 6, 12 and 24 hours after operation
Title
Sensory block levels
Description
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)
Time Frame
1, 6, 12 and 24 hours after operation
Title
Postoperative tramadol consumption
Description
total tramadol consumption in both groups will be assessed in the postoperative period
Time Frame
The first 24 hour after operation
Title
Postoperative quality of recovery
Description
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)
Time Frame
One day before surgery in outpatient clinics of anesthesiology, at 6 hours after the operation, and 24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savas Altinsoy, MD
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
university of health siences diskapi yildirim beyazit T&R hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Analgesic Efficacy of Erector Spinae Plane Block for Laparoscopic Inguinal Hernia Repair

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