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Effect of TAP Block for Postoperative Pain Control After Varicocele Operations.

Primary Purpose

Varicocele

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TAP block group (Group T)
spinal anesthesia
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Varicocele focused on measuring Varicocele, TAP block, spinal anesthesia

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

18-45 year old ASA I-II patient group

Exclusion Criteria:

  1. Contraindications for spinal anesthesia
  2. Coagulopathy
  3. Known allergy to medications used
  4. Infection in the operated area
  5. Non-volunteer patient

Sites / Locations

  • Kahramanmaras Sutcu Imam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAP block group (Group T)

Group without TAP (Group P)

Arm Description

At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.

Patients in Group P will have adjuvant added to spinal anesthesia.

Outcomes

Primary Outcome Measures

VAS (visual analog scale)
VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) score changes in the postoperative period at rest and coughing
Postoperative side effects
questionnaire for postoperative nausea, vomiting, numbness and itching
Patient satisfaction
questionnaire for patient satisfaction
time to first analgesic

Secondary Outcome Measures

Full Information

First Posted
November 30, 2016
Last Updated
June 13, 2018
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT02983383
Brief Title
Effect of TAP Block for Postoperative Pain Control After Varicocele Operations.
Official Title
Effect of TAP Block for Postoperative Pain Control After Varicocele Operations on Analgesia Quality and Postoperative Analgesic Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 18, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
TAP block is the administration of local anesthetic agents into the anatomic neurofascial cavity between the internal oblique and transversus abdominis muscle in the antero-lateral region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We aim to show the effect of TAP block administration on analgesic consumption after varicocelectomy operations, side effects linked to analgesic use and analgesic quality.
Detailed Description
The study will include 50 patients aged from 18-45 years in ASA I-II risk group undergoing varicocelectomy operations under elective conditions, randomized with a lottery method. Patients will be informed of the study and included in the study after giving permission with a patient consent form. Patients will be divided into two groups; TAP group (Group T, n=25) and P (Group P, n=25). Both groups will be taken for operation under spinal anesthesia. Those with contraindications for spinal anesthesia, with coagulopathy, with known allergy to the medications used, with infection in the operated area, and those who do not volunteer will be excluded from the study. At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block. Patients in Group P will have adjuvant added to spinal anesthesia. Patients in both groups will have pain scores assessed at 2, 4, 6, 12 and 24 hours postoperative at rest and coughing with VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) and values will be recorded. When patients are in pain, analgesic agent will be administered according to patient controlled analgesia protocol. The time of first requirement for analgesic agent and the amount of analgesic agent used in 24 hours will be recorded for patients. Side effects like postoperative nausea, vomiting, or itching will be noted. Additionally, patient satisfaction will be assessed by asking if the surgical method they experienced was bad, moderate, good or very good and recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele
Keywords
Varicocele, TAP block, spinal anesthesia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block group (Group T)
Arm Type
Active Comparator
Arm Description
At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.
Arm Title
Group without TAP (Group P)
Arm Type
Active Comparator
Arm Description
Patients in Group P will have adjuvant added to spinal anesthesia.
Intervention Type
Procedure
Intervention Name(s)
TAP block group (Group T)
Intervention Description
At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle (Stimuplex Ultra 22G, 100mm, B.Braun, Germany) tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.
Intervention Type
Procedure
Intervention Name(s)
spinal anesthesia
Intervention Description
Patients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey).
Primary Outcome Measure Information:
Title
VAS (visual analog scale)
Description
VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) score changes in the postoperative period at rest and coughing
Time Frame
24 Hours
Title
Postoperative side effects
Description
questionnaire for postoperative nausea, vomiting, numbness and itching
Time Frame
24 Hours
Title
Patient satisfaction
Description
questionnaire for patient satisfaction
Time Frame
24 Hours
Title
time to first analgesic
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-45 year old ASA I-II patient group Exclusion Criteria: Contraindications for spinal anesthesia Coagulopathy Known allergy to medications used Infection in the operated area Non-volunteer patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Boran
Organizational Affiliation
Kahramanmaraş Üniversitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaras
ZIP/Postal Code
46000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of TAP Block for Postoperative Pain Control After Varicocele Operations.

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