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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131985
• Other study ID #: Lap ing Hernia
• Status: Completed
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: November 2020
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
Turkey	university of health siences diskapi yildirim beyazit T&R hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1hour
Primary	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.	6 hours after operation
Primary	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.	12 hours after operation
Primary	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.	24 hours after operation
Primary	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.	0 hour after operation in postanesthesia care unit
Primary	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.	4 hours after operation
Secondary	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	1, 6, 12 and 24 hours after operation
Secondary	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)	1, 6, 12 and 24 hours after operation
Secondary	Postoperative tramadol consumption	total tramadol consumption in both groups will be assessed in the postoperative period	The first 24 hour after operation
Secondary	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)	One day before surgery in outpatient clinics of anesthesiology, at 6 hours after the operation, and 24 hours after operation