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Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia

Primary Purpose

Pain, Postoperative, Postoperative Complications, Inguinal Hernia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal anesthesia (with nerve block)
Sponsored by
Konya City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring spinal anesthesia, inguinal Hernia, general anesthesia, laparoscopic total extraperitoneal repair

Eligibility Criteria

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

Inclusion Criteria: Patients with inguinal hernias. Over 18 years old Exclusion Criteria: Younger than 18 years Those who have had previous abdominal surgery, Incarcerated or strangulated inguinal hernias, Recurrent hernias, Coagulopathies, Patients with musculoskeletal deformity, Those with chronic pain, Those who use drugs that affect the central nervous system daily, Those with a body mass index (BMI) over 40 kg/m2, Patients with contraindications to the recommended anesthetic technique.

Sites / Locations

  • University of Health Science Van Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

General anesthesia (GA) Group

Spinal anesthesia (with nerve block) (SA) Group

Arm Description

General anesthesia: No premedication will be applied. In the waiting room, 10 mL/kg of Ringer's lactate solution will be infused IV in 30 minutes. In Group I, 2-2.5 mg/kg propofol and 1 μg/kg fentanyl IV will be given for induction; 0.6 mg/kg rocuronium will then be used to provide the muscle relaxation needed for intubation. After intubation, the tidal volume will be set to 6-8 mL/kg and the respiratory frequency PetCO2 32-36 mmHg in volume-controlled ventilation (VCV) mode. Anesthesia will continue to be provided with sevoflurane (1.5%-2%), oxygen-air mixture (FiO 2 = 0.4) and repeated doses of rocuronium (0.015 mg/kg). At the end of the surgery, neostigmine (2-2.5 mg) and atropine (1 mg) will be given IV to antagonize the residual neuromuscular block.

Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.

Outcomes

Primary Outcome Measures

Postoperative pain
It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.

Secondary Outcome Measures

Adverse postoperative events
headache, nausea/vomiting, anxiety, abdominal discomfort and urinary retention

Full Information

First Posted
April 19, 2023
Last Updated
September 19, 2023
Sponsor
Konya City Hospital
Collaborators
Van Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05837013
Brief Title
Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia
Official Title
Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia With Nerve Block Versus General Anesthesia: a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya City Hospital
Collaborators
Van Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the most frequently applied method is laparoscopic total extraperitoneal repair (TEP). In general, this surgery is performed under general anesthesia (GA) in many centers. However, in cases where general anesthesia is inconvenient, local or other anesthesia methods are preferred. It has been stated in many studies in the literature that this surgery can be performed with methods other than general anesthesia. In a study of 480 patients, one of which was Sinha et al., it was shown that this surgical procedure was successfully performed under spinal anesthesia (SA). In a prospective randomized study by Dönmez et al., patients who underwent TEP under general anesthesia and spinal anesthesia were compared. It has been reported that TEP repair can be performed safely under SA and that SA is associated with less postoperative pain, better recovery, and better patient satisfaction than GA.2 In a retrospective study by Yıldırım et al. It has been shown that there is significantly less need for analgesics and better patient satisfaction. There are also many meta-analyses made on this subject in the literature. Compared with GA in these, SA was associated with a longer operative time, and postoperative pain and nausea and vomiting were less in SA. However, the risk of urinary retention in SA was significantly increased. It was observed that there was no significant difference in surgical complications such as seroma and wound infection. Despite all these studies, until now, there is no clear consensus on which anesthesia should be used. The aim of the study is to compare the results of spinal anesthesia with nerve block and general anesthesia in TEP repair.
Detailed Description
Patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair with the diagnosis of inguinal hernia will be divided into 2 groups. General anesthesia (GA) will be applied to the 1st group, and ileoinguinal (II) and ileohypogastric (IH) nerve block together with spinal anesthesia (SA) to the 2nd group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Complications, Inguinal Hernia
Keywords
spinal anesthesia, inguinal Hernia, general anesthesia, laparoscopic total extraperitoneal repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia (GA) Group
Arm Type
Experimental
Arm Description
General anesthesia: No premedication will be applied. In the waiting room, 10 mL/kg of Ringer's lactate solution will be infused IV in 30 minutes. In Group I, 2-2.5 mg/kg propofol and 1 μg/kg fentanyl IV will be given for induction; 0.6 mg/kg rocuronium will then be used to provide the muscle relaxation needed for intubation. After intubation, the tidal volume will be set to 6-8 mL/kg and the respiratory frequency PetCO2 32-36 mmHg in volume-controlled ventilation (VCV) mode. Anesthesia will continue to be provided with sevoflurane (1.5%-2%), oxygen-air mixture (FiO 2 = 0.4) and repeated doses of rocuronium (0.015 mg/kg). At the end of the surgery, neostigmine (2-2.5 mg) and atropine (1 mg) will be given IV to antagonize the residual neuromuscular block.
Arm Title
Spinal anesthesia (with nerve block) (SA) Group
Arm Type
Active Comparator
Arm Description
Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia (with nerve block)
Intervention Description
Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10.
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Adverse postoperative events
Description
headache, nausea/vomiting, anxiety, abdominal discomfort and urinary retention
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with inguinal hernias. Over 18 years old Exclusion Criteria: Younger than 18 years Those who have had previous abdominal surgery, Incarcerated or strangulated inguinal hernias, Recurrent hernias, Coagulopathies, Patients with musculoskeletal deformity, Those with chronic pain, Those who use drugs that affect the central nervous system daily, Those with a body mass index (BMI) over 40 kg/m2, Patients with contraindications to the recommended anesthetic technique.
Facility Information:
Facility Name
University of Health Science Van Training and Research Hospital
City
Van
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Hilmi Yılmaz, MD
Phone
0432 222 00 10
Email
drabdullahhilmi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18803509
Citation
Sinha R, Gurwara AK, Gupta SC. Laparoscopic total extraperitoneal inguinal hernia repair under spinal anesthesia: a study of 480 patients. J Laparoendosc Adv Surg Tech A. 2008 Oct;18(5):673-7. doi: 10.1089/lap.2007.0219.
Results Reference
background
PubMed Identifier
27822053
Citation
Donmez T, Erdem VM, Sunamak O, Erdem DA, Avaroglu HI. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study. Ther Clin Risk Manag. 2016 Oct 27;12:1599-1608. doi: 10.2147/TCRM.S117891. eCollection 2016.
Results Reference
background
PubMed Identifier
29362658
Citation
Yildirim D, Hut A, Uzman S, Kocakusak A, Demiryas S, Cakir M, Tatar C. Spinal anesthesia is safe in laparoscopic total extraperitoneal inguinal hernia repair. A retrospective clinical trial. Wideochir Inne Tech Maloinwazyjne. 2017 Dec;12(4):417-427. doi: 10.5114/wiitm.2017.72325. Epub 2017 Dec 29.
Results Reference
background
PubMed Identifier
32156258
Citation
Li L, Pang Y, Wang Y, Li Q, Meng X. Comparison of spinal anesthesia and general anesthesia in inguinal hernia repair in adult: a systematic review and meta-analysis. BMC Anesthesiol. 2020 Mar 10;20(1):64. doi: 10.1186/s12871-020-00980-5.
Results Reference
background
PubMed Identifier
32217883
Citation
Hajibandeh S, Hajibandeh S, Mobarak S, Bhattacharya P, Mobarak D, Satyadas T. Meta-Analysis of Spinal Anesthesia Versus General Anesthesia During Laparoscopic Total Extraperitoneal Repair of Inguinal Hernia. Surg Laparosc Endosc Percutan Tech. 2020 Aug;30(4):371-380. doi: 10.1097/SLE.0000000000000783.
Results Reference
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Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia

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