Comparison of Postoperative Analgesic Efficacy of TAP Block and TFP Block in Patients Undergoing Abdominal Hysterectomy

Not Applicable

Completed

• Conditions: Hysterectomy, Benign Uterine Diseases; Abdominal Pain (AP)

• Registration Number: NCT06853782
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2023-07-15
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-18
• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-03
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	Postoperative 30th minute, 1st, 2nd, 12th and 24th hours	Postoperative pain assessment will be performed by a researcher at 30th minutes,1st, 2nd, 12th and 24th hours after the block, using the Numerical Rating Scale (NRS) for pain in movement. Patients will be blinded to the groups they participate in and asked to rate their pain on a scale from 0 to 10, where 0 means no pain and 10 represents the worst pain they can imagine.

Secondary Outcome Measures

Name	Time	Method
Adverse Reactions	Postoperative 24th hour	Opioid associated side effects such as nausea, vomiting, constipation, pruritis, urinary retention, respiratory depression and block related complications will be assessed.
Patient Satisfaction	Postoperative 24th hour	Patient satisfaction will be assessed by asking patients to choose one of the following options regarding their postoperative comfort: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied.
Early Mobilization	Postoperative 24th hour	Early mobilization will be assessed based on whether the patient started to walk within the first 24 hours postoperatively.
Duration of Postoperative Hospital Stay	Postoperative 7th day	The duration of the postoperative hospital stay will be assessed by checking the operation day and discharge day in the hospital records.
Tramadol Consumption	Postoperative 0-6th, 6-12th, 12-24th hours	Tramadol consumption (between 0-6, 6-12, 12-24 hours) will be assessed by a patient controlled analgesia (PCA) device.; Additionally, in patients receiving rescue tramadol, the amount of tramadol required will be evaluated by reviewing the patient's daily medication order records.
Rescue Tramadol Need	Postoperative 0-24th hours	The need for rescue tramadol (Present/Absent), will be assessed by reviewing the patient's daily medication order records.

Trial Locations

Locations (1)

Hacettepe University Hospital; 🇹🇷 Ankara, Turkey