NCT06853782

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. 1.Pain scores in motion
  2. 2.Opioid consumption

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
Last Updated

January 6, 2026

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 24, 2025

Last Update Submit

January 3, 2026

Conditions

Keywords

Transversus Abdominis Plane BlockTransversalis Fascia Plane BlockTotal Abdominal HysterectomyPostoperative AnalgesiaUltrasound

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    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.

    Postoperative 30th minute, 1st, 2nd, 12th and 24th hours

Secondary Outcomes (6)

  • Tramadol Consumption

    Postoperative 0-6th, 6-12th, 12-24th hours

  • Rescue Tramadol Need

    Postoperative 0-24th hours

  • Adverse Reactions

    Postoperative 24th hour

  • Patient Satisfaction

    Postoperative 24th hour

  • Early Mobilization

    Postoperative 24th hour

  • +1 more secondary outcomes

Study Arms (2)

TAP Block Group

ACTIVE COMPARATOR

In the TAP block group, the lateral transversus abdominis plane block will be performed by the anesthesiologist under ultrasound guidance using a linear probe after the completion of the surgery. Patients will receive 40 ml of 0.25% bupivacaine, administered in two equal doses, into the fascial plane between the internal oblique muscle and the transversus abdominis muscle on both sides.

Device: High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)

TFP Block Group

ACTIVE COMPARATOR

In the TFP block group, the transversalis fascia plane block will be performed by the anesthesiologist under ultrasound guidance using a linear probe after the completion of the surgery. Patients will receive 40 ml of 0.25% bupivacaine, administered in two equal doses, between transversus abdominis muscle and transversalis fascia on both sides.

Device: High Frequency Linear Probe (GE Logic e R7 Ultrasonography Device, USA)

Interventions

A high frequency linear probe (GE Logic e R7 Ultrasonography Device, USA) device will be used while blocking in both groups.

TAP Block Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Hospital

Ankara, Turkey, 06230, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 27067036BACKGROUND
  • 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.

    PMID: 19020158BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 3, 2025

Study Start

July 15, 2023

Primary Completion

September 12, 2023

Study Completion

September 18, 2023

Last Updated

January 6, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Via mail

Locations