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

Effect of TAP Block for Postoperative Pain Control After Varicocele Operations on Analgesia Quality and Postoperative Analgesic Consumption

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.

Study Overview

• Status: Completed
• Conditions: Varicocele
• Intervention / Treatment: Procedure: TAP block group (Group T); Procedure: spinal anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaras, Turkey, 46000
    • Kahramanmaras Sutcu Imam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TAP block group (Group T); 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); 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.
ACTIVE_COMPARATOR: Group without TAP (Group P); Patients in Group P will have adjuvant added to spinal anesthesia.	Procedure: spinal anesthesia; Patients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): May 18, 2018
• Study Completion (ACTUAL): June 13, 2018

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (ESTIMATE): December 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: spinal anesthesia; Varicocele; TAP block
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Varicocele; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO