NCT02983383

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2018

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

November 30, 2016

Last Update Submit

June 13, 2018

Conditions

Varicocele

Keywords

VaricoceleTAP blockspinal anesthesia

Outcome Measures

Primary Outcomes (4)

  • 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

    24 Hours

  • Postoperative side effects

    questionnaire for postoperative nausea, vomiting, numbness and itching

    24 Hours

  • Patient satisfaction

    questionnaire for patient satisfaction

    24 Hours

  • time to first analgesic

    24 hours

Study Arms (2)

TAP block group (Group T)

ACTIVE COMPARATOR

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.

Procedure: TAP block group (Group T)

Group without TAP (Group P)

ACTIVE COMPARATOR

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

Procedure: spinal anesthesia

Interventions

TAP block group (Group T)PROCEDURE

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.

TAP block group (Group T)
spinal anesthesiaPROCEDURE

Patients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey).

Group without TAP (Group P)

Eligibility Criteria

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

You may qualify if:

  • year old ASA I-II patient group

You may not qualify if:

  • Contraindications for spinal anesthesia
  • Coagulopathy
  • Known allergy to medications used
  • Infection in the operated area
  • Non-volunteer patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Varicocele

Interventions

Sensitivity Training GroupsAnesthesia, Spinal

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Ömer Faruk Boran

    Kahramanmaraş Üniversitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 6, 2016

Study Start

December 1, 2016

Primary Completion

May 18, 2018

Study Completion

June 13, 2018

Last Updated

June 14, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)