Transversus Abdominis Plan Block Versus Rectus Sheath Block

NCT06897345 | Not Yet Recruiting

• 1 other identifier: salkaya-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator aims to compare the analgesic efficacy of Transversus Abdominis Plan Block and Rectus Sheath Block which are used to prevent intraoperative and postoperative pain and reduce the use of opioid in abdominoplasty operations.

Conditions

Abdominal Obesity; Postoperative Pain; Postoperative Complications

Keywords

post operative pain; transversus abdominis plane block; rectus sheat block

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The Visual Analog Scale (VAS) score is a subjective measurement tool used to assess the intensity of pain. It is commonly used in clinical settings to help patients communicate their pain levels to healthcare providers. The VAS typically consists of a straight line, often 10 centimeters long, with one end labeled "no pain" (0) and the other end labeled "worst pain imaginable" (10). Patients mark a point on the line that corresponds to their current level of pain.

  VAS scores were measured at the beginning, st, 3rd, 6th, 12th and 24th hour in the postoperative recovery unit.

Secondary Outcomes (2)

• total analgesic consumption

  24 hour

• first analgesic need

  24 hour

Study Arms (2)

transversus abdominis plane block

ACTIVE COMPARATOR

After administering 0.02 mg/kg midazolam for sedation to Group TAP patients, they will be placed in the supine position on both sides under sterile conditions using the high-frequency linear probe of the Esaote CA631 brand ultrasound, and the linear probe will be slid from the bilateral umblicus level to the midaxillary line, and when the internal and external oblique muscles are seen, the needle will be advanced from medial to lateral in an inplane manner, and the fascia between the internal oblique and transversus abdominis muscles will be reached, and after negative aspiration, 20 cc of 0.25% bubivacaine will be injected.

Procedure: transversus abdominis plane block

rectus sheat block

ACTIVE COMPARATOR

After administering 0.02 mg/kg midazolam for sedation, in the supine position, under sterile conditions, using the high-frequency linear probe of the Esaote CA631 brand ultrasound, 1 cm laterally over the umblicus, and after negative aspiration between the rectus muscle and the posterior rectus sheath, 20 cc of 0.25% bubivacaine will be injected (bilateral). 15 minutes after the block is applied, general anesthesia will be applied to the patients in both groups with 1 mcg/kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg rocuronium intravenously and they will be orotracheal intubated. Intraoperative remifentanil needs will be recorded. Within the scope of multimodal analgesia, 1 g paracetamol will be administered to all patients 30 minutes before the end of the operation and 3 mg/kg sugammadex will be administered at the end of the operation and they will be extubated.

Procedure: rectus sheat block

Interventions

transversus abdominis plane block PROCEDURE

The transversus abdominis plane (TAP) block is a regional anesthesia technique used primarily to provide pain relief for patients undergoing surgery in the abdominal region. The TAP block targets the nerves that supply sensations to the skin and muscles of the abdominal wall.

Also known as: bupivakain

transversus abdominis plane block

rectus sheat block PROCEDURE

The rectus sheath block is a type of regional anesthesia used primarily for pain management in the abdominal area. It involves injecting local anesthetic into the rectus sheath, which is the fibrous sheath that envelops the rectus abdominis muscle. This block targets the lower intercostal nerves as they traverse through the sheath, thereby providing analgesia to the anterior abdominal wall.

Also known as: bupivakain

rectus sheat block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will undergo elective abdominoplasty
• Patients between the ages of 18-65
• ASA (American Society of Anesthesiologists) I-II-III patients
• Patients with a body weight between 50-80 kg

You may not qualify if:

• \- ASA IV patient group
• Patients under 18 years of age
• Patients without cooperation
• Patients with chronic alcohol use
• Patients in whom peripheral plane block application is contraindicated (infection at the application site, coagulopathy, local anesthetic allergy)
• Patients who do not want to participate in the study

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Abdominal; Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• LEYLA KILINC

  şişli etfal eğitim araştırma hastanesi

  STUDY CHAIR

Central Study Contacts

AYSEL SALKAYA

CONTACT

+905062046172; ayselsalkaya34@hotmail.com

MUSTAFA ALTINAY

CONTACT

05333914422; m_altinay@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)