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

NCT ID: NCT02983383

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-06-13

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.

Conditions

Varicocele

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TAP block group (Group T)

Intervention Type: 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.

Group without TAP (Group P)

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

Group Type: ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

spinal anesthesia

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Ömer Faruk Boran

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ömer Faruk Boran

Role: STUDY_CHAIR

Kahramanmaraş Üniversitesi

Locations

Kahramanmaras Sutcu Imam University

Kahramanmaraş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

53

Identifier Type: -

Identifier Source: org_study_id