Clinical trial NCT06853782: Comparison of Postoperative Analgesic Efficacy of TAP Block and TFP Block in Patients Undergoing Abdominal Hysterectomy
Official title: Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block and Transversalis Fascia Plane (TFP) Block in Patients Undergoing Elective Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy, Benign Uterine Diseases
Abdominal Pain (AP)
Keywords: Transversus Abdominis Plane Block
Transversalis Fascia Plane Block
Total Abdominal Hysterectomy
Postoperative Analgesia
Ultrasound
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total abdominal hysterectomy is one of the most commonly performed surgeries in women and is known to cause significant pain in especially early postoperative period. The goal of this clinical trial is to compare analgesic efficiacy of TAP block, which is well established by studies in hysterectomy surgeries, and TFP block, a relatively new block with good analgesic effect when used for lower abdominal surgeries, in patients undergoing abdominal hysterectomy surgery.The main parameters to compare the analgesic efficiacy of TAP and TFP blocks are;

1. Pain scores in motion
2. Opioid consumption

Researchers will apply the lateral TAP block and TFP block, prepare the postoperative analgesic treatment regimen and record the patients' analgesic consumption, make ward visits and ask patients about their pain intensity and check for opioid consumption and associated side effects, block-related complications, mobilization, length of hospital stay, and patient satisfaction in patients undergoing elective total abdominal hysterectomy surgery.

Participants will score the pain they feel in motion with certain pain scales.Participants will also respond to the researchers' questions for other parameters in study.

Detailed description: Total abdominal hysterectomy is a commonly performed surgical procedure in women that involves the surgical removal of the uterus and is known to cause significant pain, especially during the early postoperative period.

This study aims to prospectively compare the effects of lateral TAP block and TFP block in patients undergoing elective total abdominal hysterectomy with Pfannenstiel incision under general anesthesia for benign uterine neoplasms in a randomized controlled manner.

The TAP block is a fascial plane block targeting the trunkal T6-T12/L1 nerves located between the internal oblique and transversus abdominis muscles and is an effective regional anesthesia method for abdominal surgeries. In patients undergoing total abdominal hysterectomy, TAP block significantly reduces opioid consumption during the postoperative period and results in marked decreases in pain scores at rest and during movement without causing side effects.

The TFP block is a regional analgesia method used in lower abdominal surgeries targeting the branches of the trunkal T12-L1 nerves, located between the transversus abdominis muscle and transversalis fascia. While the TAP block covers dermatomes from T6-L1, the TFP block targets dermatomes T12-L1. A significant difference from the TAP block is that the TFP block provides effective analgesia in areas innervated by the lateral cutaneous branches emerging from the L1 dermatome that TAP block may not fully cover.

Eligibility criteria: Inclusion Criteria:

* ASA scores of 1-2
* Adults aged 18+ years
* Diagnosed with benign uterine neoplasms and will undergo elective total abdominal hysterectomy via Pfannenstiel incision under general anesthesia
* Agreed to participate in the study will be included.

Exclusion Criteria:

* Patients with known

  * Neuropathy
  * Renal failure
  * Hepatic failure
  * Coagulopathy
* Skin infection at the site of intervention
* Allergy to local anesthetics
* BMI \> 35 kg/m²
* Hysterectomy surgery extended due to malignancy or multiple surgeries during the same hospitalization
* Emergency surgeries
* ASA scores of 3-4
* Emergency surgery
* Patients who do not consent to participate in the study will be excluded.

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Postoperative 30th minute, 1st, 2nd, 12th and 24th hours
Secondary outcomes:
measure: Tramadol Consumption
timeFrame: Postoperative 0-6th, 6-12th, 12-24th hours
measure: Rescue Tramadol Need
timeFrame: Postoperative 0-24th hours
measure: Adverse Reactions
timeFrame: Postoperative 24th hour
measure: Patient Satisfaction
timeFrame: Postoperative 24th hour
measure: Early Mobilization
timeFrame: Postoperative 24th hour
measure: Duration of Postoperative Hospital Stay
timeFrame: Postoperative 7th day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
Study officials:
References:
citation: Lopez-Gonzalez JM, Lopez-Alvarez S, Jimenez Gomez BM, Arean Gonzalez I, Illodo Miramontes G, Padin Barreiro L. Ultrasound-guided transversalis fascia plane block versus anterior transversus abdominis plane block in outpatient inguinal hernia repair. Rev Esp Anestesiol Reanim. 2016 Nov;63(9):498-504. doi: 10.1016/j.redar.2016.02.005. Epub 2016 Apr 8. English, Spanish.
citation: Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.