NCT03793764

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 26, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

December 26, 2018

Last Update Submit

November 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesic consumption

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

    postoperative 24 hours

Secondary Outcomes (1)

  • Patient satisfacion

    postoperative 24 hours

Study Arms (3)

Group T

ACTIVE COMPARATOR

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

Procedure: TAP block

Group Q

ACTIVE COMPARATOR

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

Procedure: QL block

Group C

NO INTERVENTION

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

Interventions

TAP blockPROCEDURE

USG guided TAP block

Group T
QL blockPROCEDURE

USG guided QL block

Group Q

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 1-2
  • Patients undergoing varicocele surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46000, Turkey (Türkiye)

RECRUITING

Kahramanmaraş Sütçü Imam Üniversity

Kahramanmaraş, 46000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ömer F Boran

    Bay

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients undergoing varicocele surgery under spinal anesthesia
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2018

First Posted

January 4, 2019

Study Start

December 25, 2018

Primary Completion

April 25, 2020

Study Completion

June 25, 2020

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations