Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia

March 20, 2024 updated by: Mehmet Eşref Ulutaş, Konya City Hospital

Comparison of Open and Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TEP) Performed Under Blocked Spinal Anesthesia and General Anesthesia: Prospective Randomized Study

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 show the effect of both the surgical method and the anesthesia method on the patient during surgery and in the early postoperative period in inguinal hernia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair and open surgical procedure (Lichtenstein) 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey
        • University of Health Science Van Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General anesthesia (GA) and TEP Group
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.
Procedure: General anesthesia (GA)
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.
Active Comparator: Spinal anesthesia (with nerve block) (SA) and TEP Group
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.
Procedure: Spinal anesthesia (with nerve 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.
Experimental: General anesthesia (GA) and open surgical procedure (Lichtenstein)
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.
Procedure: General anesthesia (GA)
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.
Active Comparator: Spinal anesthesia (with nerve block) (SA) open surgical procedure (Lichtenstein)
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.
Procedure: Spinal anesthesia (with nerve 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: Postoperative 24 hours
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.
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse postoperative events
Time Frame: Postoperative 24 hours
headache, nausea/vomiting, anxiety, abdominal discomfort and urinary retention
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Collaborators

Van Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33333333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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