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Comparison of TAP Bock vs QL Block in Varicocele Surgery

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TAP block
QL block
Sponsored by
Ömer Faruk Boran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

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

Inclusion Criteria:

  • ASA 1-2
  • Patients undergoing varicocele surgery

Exclusion Criteria:

  • Patient refusal
  • Coagulation abnormality.
  • contraindication for spinal anesthesia
  • Failed block

Sites / Locations

  • Kahramanmaras Sutcu Imam UniversityRecruiting
  • Kahramanmaraş Sütçü Imam ÜniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group T

Group Q

Group C

Arm Description

At the end of the surgery USG guided TAP block will be performed with 20 mL of 0.25% isobaric bupivacaine.

At the end of the surgery USG guided QL block will be performed with 20 mL of 0.25% isobaric bupivacaine.

In this group no intervention will be performed after the end of operation.

Outcomes

Primary Outcome Measures

Postoperative analgesic consumption
The amount of analgesic agent consumption in the postoperative 24 hours with iv PCA will be recorded.

Secondary Outcome Measures

Patient satisfacion
Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.

Full Information

First Posted
December 26, 2018
Last Updated
November 15, 2019
Sponsor
Ömer Faruk Boran
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1. Study Identification

Unique Protocol Identification Number
NCT03793764
Brief Title
Comparison of TAP Bock vs QL Block in Varicocele Surgery
Official Title
The Comparison of TAP Block and QL Block on Postoperative Analgesic Consumption and Patient Satisfaction After Varicocele Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 25, 2018 (Actual)
Primary Completion Date
April 25, 2020 (Anticipated)
Study Completion Date
June 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ömer Faruk Boran

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
In this study we aim to compare the effect of TAP block and QL block on postoperative analgesia, analgesic consumption , side effects and patient satisfaction after varicocelec surgery. 75 patients will be randomized into 3 groups:TAP Group (Group T) n = 25, QL Group (Group Q) n = 25, Control Group (Group K) n = 25 All patients will be operated on with spinal anesthesia. TAP and QL blocks will be performed after completion of the surgeries. In the postoperative care unit, an iv patient-controlled analgesia protocol with tramadol will be started. Patients in all three groups will be assessed with a resting and cough VAS (visual analog scale) at postoperative 2,4,6,12,18 and 24 hours and values will be recorded. The amount of analgesic consumption and the first analgesic request times will be recorded. Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. In addition, patient satisfaction will be assessed with these methods as bad, medium, good, and very good.
Detailed Description
Purpose:TAP is the application of local anesthetic agents to block the anterior neck of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves in the anatomic neurofascial gap between the internal oblique and transversus abdominis muscle located in the anterolateral region of the abdomen. It was first described by Rafi in 2001. Then in 2007 Hebbart et al. described that using USG, TAP block could be implemented more effectively and safely. With QL block, a local anesthetic agent is applied to the posterior layer of the thoracolumbar fascia and similar nerve blockage is achieved. The technique was first described by Blanco in 2007. TAP block and QL block may be a good method for postoperative pain control. We aimed to compare the efficacy of TAP block and QL block to analgesic consumption after varicocelectomy operations, analgesic side effects and analgesia quality and to compare these two block efficacy. Material & Method:75 patients in the ASA I-II risk group, aged 18-45 years, who will undergo elective varicocelectomy surgery, will be randomized using the cohort procedure. The patient will be informed about the study and will be included in the study after the patient is approved with the approval form. The three groups will be divided into TAP Group (Group T) n = 25, QL Group (Group Q) n = 25, Control Group (Group K) n = 25. A total of 75 patients were planned to receive α = 0,05 at the β: 0.20 level and 0.80 at the power level and n = 25 for each group. Reference work including VAS scores and I-TAP method was taken into consideration when the sample size of the study was determined. The normal distribution of data in the statistical evaluation of the study will be examined by the Shapiro-Wilk test. One-way ANOVA will be performed for comparison of groups (if the data are normally distributed). Multiple comparisons Tukey test, Dunnett test Tamhane T2 test will be applied. (Kruskal-Wallis H test will be applied in cases where it does not normally disperse.) Multiple comparison will be performed with the Dunn-Sidak test. Statistical significance is accepted as p <0.05, data will be examined in the IBMSPSS program. All three patients will be operated on with spinal anesthesia. Patients with coagulopathy who are contraindicated for spinal anesthesia, known allergies to the drugs to be used, infected and non-voluntary patients to be excluded from the study. At the end of the disease operation in Group T, after the necessary antiseptic conditions are established in the supine position, the USG probe midpoint (within the petit triangle). After the abdominal muscle layers are seen, the facial muscle sensation is taken when the needle-like muscular layers and facial muscles pass, and the needle is controlled with USG. After receiving the second click feeling (passage of the internalocutaneous fascia), the needle-like localization will be determined by applying a test dose of 0.5-1 ml. After localization is confirmed, frequent aspiration and local anesthetic agent will be given to the neurophysiologic plan and TAP block will be applied. To apply the lateral QL block to the patient in Group Q, a low frequency convex probe is inserted into the patient while the patient is in the supine position. Quadratus lumborum block 1 is injected with 20 mL of local anesthetic on the lateral side of the QL muscle in the area where the transversus abdominis muscle contacts the transversal fascia at the level that enters the aponeurope. Local analgesics will not be administered with Group III disease needle. When the patient is removed to the postoperative care unit, an iv patient-controlled analgesia device will be applied. Patients in all three groups will be assessed with a resting and cough VAS (visual analog scale) at postoperative 2,4,6,12,18 and 24 hours (pain intensity: 0 no pain and 10: the most severe pain I have ever heard) and values will be recorded. When the patient has a pain, an analgesic agent will be given according to the patient-controlled analgesia protocol. The amount of analgesic agent consumed by the patients when the first analgesic agent is needed and 24 hours will be recorded. Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. In addition, patient satisfaction will be assessed with these methods as bad, medium, good, and very good.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients undergoing varicocele surgery under spinal anesthesia
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group T
Arm Type
Active Comparator
Arm Description
At the end of the surgery USG guided TAP block will be performed with 20 mL of 0.25% isobaric bupivacaine.
Arm Title
Group Q
Arm Type
Active Comparator
Arm Description
At the end of the surgery USG guided QL block will be performed with 20 mL of 0.25% isobaric bupivacaine.
Arm Title
Group C
Arm Type
No Intervention
Arm Description
In this group no intervention will be performed after the end of operation.
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
USG guided TAP block
Intervention Type
Procedure
Intervention Name(s)
QL block
Intervention Description
USG guided QL block
Primary Outcome Measure Information:
Title
Postoperative analgesic consumption
Description
The amount of analgesic agent consumption in the postoperative 24 hours with iv PCA will be recorded.
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
Patient satisfacion
Description
Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.
Time Frame
postoperative 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: ASA 1-2 Patients undergoing varicocele surgery Exclusion Criteria: Patient refusal Coagulation abnormality. contraindication for spinal anesthesia Failed block
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer F Boran
Phone
03442803796
Email
omerfarukboran@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer F Boran
Organizational Affiliation
Bay
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University
City
Kahramanmaras
ZIP/Postal Code
46000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Boran
Phone
+903442803434
Ext
3796
Email
omerfarukboran@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Boran
Facility Name
Kahramanmaraş Sütçü Imam Üniversity
City
Kahramanmaras
ZIP/Postal Code
46000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Boran
Phone
3442803796
Ext
3796
Email
omerfarukboran@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of TAP Bock vs QL Block in Varicocele Surgery

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