- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06853782
Comparison of Postoperative Analgesic Efficacy of TAP Block and TFP Block in Patients Undergoing Abdominal Hysterectomy
Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block and Transversalis Fascia Plane (TFP) Block in Patients Undergoing Elective Total Abdominal Hysterectomy
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;
- Pain scores in motion
- 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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Turkey
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Ankara, Turkey, Turkey (Türkiye), 06230
- Hacettepe University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TAP Block Group
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.
|
A high frequency linear probe (GE Logic e R7 Ultrasonography Device, USA) device will be used while blocking in both groups.
|
|
Active Comparator: TFP Block Group
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.
|
A high frequency linear probe (GE Logic e R7 Ultrasonography Device, USA) device will be used while blocking in both groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale
Time Frame: 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.
|
Postoperative 30th minute, 1st, 2nd, 12th and 24th hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tramadol Consumption
Time Frame: 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. |
Postoperative 0-6th, 6-12th, 12-24th hours
|
|
Rescue Tramadol Need
Time Frame: Postoperative 0-24th hours
|
The need for rescue tramadol (Present/Absent), will be assessed by reviewing the patient's daily medication order records.
|
Postoperative 0-24th hours
|
|
Adverse Reactions
Time Frame: Postoperative 24th hour
|
Opioid associated side effects such as nausea, vomiting, constipation, pruritis, urinary retention, respiratory depression and block related complications will be assessed.
|
Postoperative 24th hour
|
|
Patient Satisfaction
Time Frame: 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.
|
Postoperative 24th hour
|
|
Early Mobilization
Time Frame: Postoperative 24th hour
|
Early mobilization will be assessed based on whether the patient started to walk within the first 24 hours postoperatively.
|
Postoperative 24th hour
|
|
Duration of Postoperative Hospital Stay
Time Frame: 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.
|
Postoperative 7th day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-22062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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