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Post-Op ComplicationTAPBLOCKNCT04364477

TAP Block On Abdominal Surgery Patients With General Anesthesia

A study testing transversus abdominis plane (TAP) block in people with Post-Op Complication and Pain, Postoperative, run by Cumhuriyet University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

INTRODUCTION: The aim of this study was to investigate the effects of tranversus abdominis plane (TAP) block placed postoperatively using ultrasound guidance for patients with caesarean section, myomectomy and hysterectomy under general anesthesia by eliminating additional pain caused by surgical incision. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Post-Op Complication, Pain, Postoperative
What is being tested?
transversus abdominis plane (TAP) block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
4 Jan 2015to 1 Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria: 1) ASA I and II patients. 2) Healthy people.

Exclusion Criteria: 1)Those with skin infections, 2) Patients with organomegaly (hepatomegaly and splenomegaly), 3) People who did not give consent to the method. 4) Individuals with allergies to drugs to be used in the intervention area where Transversus abdominis plane is to be conducted were not included in the study.

About this study

Official title: The Effect Of The Transversus Abdominis Plane Block On Postoperative Analgesia and Patient Comfort In Patients Having Abdominal Surgery With General Anesthesia

INTRODUCTION: The aim of this study was to investigate the effects of tranversus abdominis plane (TAP) block placed postoperatively using ultrasound guidance for patients with caesarean section, myomectomy and hysterectomy under general anesthesia by eliminating additional pain caused by surgical incision.

MATERIALS AND METHODS: The study has been planned to investigate the postoperative analgesia of 50 patients with TAP blocks applied and non-applied between the ages of 18-65, who will pass abdominal surgery. Study has been conducted in a prospective, randomized and controlled manner. Patients have been classified as those who have undergone TAP block (group: I) and those without block (group: II).

Read the detailed description

The study was conducted in accordance with the Helsinki Declaration Principles (rev.2013) and with the approval of the local ethical board. After the written and signed approval of the patients, it has been planned to investigate the postoperative analgesia and comfort of a total of 50 patients The study examined the postoperative pain levels after abdominal surgery with and without TAP block. Subjects were between the ages of 18-65 who will have abdominal surgery with transverse incision (cesarean section, hysterectomy (benign), myomectomy) and American Society of Anesthesiologists Physical Status Classification System (ASA) I-II. Our study is planned to be prospective, randomized and controlled. The individuals to be engaged were divided into two groups in a randomized form. Randomization was based on a computer-generated code. In the first group, a total of 25 patients were admitted with 16 cesareans, 6 myomectomies and 3 hysterectomies applied to the TAP block. In the second group, a total of 25 patients who did not undergo TAP block, no needle intervention, 18 cesareans, 5 myomectomies and 2 hysterectomies were included as the control group. Those with skin infections, patients with organomegaly (hepatomegaly and splenomegaly), people who did not give consent to the method, and individuals with allergies to drugs to be used in the intervention area where Transversus abdominis plane is to be conducted were not included in the study.

Isolyte® balanced electrolyte solution at a rate of 2 ml/kg/hour was administered to the individuals whose oral intake was discontinued 8 hours before the surgery. The individuals to be included in the study were not given any sedative agent on the morning of their surgery. 10 cm visual analog scale (VAS) was explained in detail to all patients before the procedure. All individuals to be included in the study were followed up with anesthesia monitor (Drager Infinity Vista XL®), heart rate (CAH), electrocardiography (ECG) (lead II), systolic blood pressure (SKB) and diastolic blood pressure (DBP) in the preoperative and preoperative period. After induction of anesthesia with 1 µg/kg fentanyl (Fentanyl, Janssen-Cilag), 0.5 mg/kg rocuronium bromide (Esmeron® vial, Schering-Plough) and 5 mg/kg thiopental sodium (Pental Sodium®, I.E Ulagay), 4-6% Desflurane (Suprane® Volatile Solution, Pharmacist-Head - Baxter) and 50% N2O in Oxygen were used to maintain anesthesia following endotracheal intubation. Differently in general anesthesia management at cesarean operations, 5 mg/kg thiopental sodium (Pental Sodium®, I.E Ulagay) and 0.5 mg/kg rocuronium bromide (Esmeron® vial, Schering-Plough) were administered in induction and 4-6% Desflurane (Suprane® Volatile Solution, Pharmaceutical-headed-Baxter), (50% N2O+50% Oxygen) and 1 µg/kg fentanyl (Fentanyl, Janssen-Cilag) are added as inhalation anesthesia after umbilical cord clamping in maintenance. The maintenance dose of rocuronium bromide was 0.15 mg/kg for all cases. Necessary fluid replacement was performed during the operation. At the end of the operation, TAP blocks were placed to the 1st group patients.

After the necessary sterilization conditions were established, the linear ultrasound probe was sterilely coated and placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle and peritoneum were identified. As the tip of the 21Gx100 mm needle (Pajunk®-Uniplex Nanoline cannula with facet tip) passed through the muscular layers and fascia, a fascial click was felt and the needle was advanced with ultrasound in a controlled manner. After receiving the second click sensation (passage of the fascia of the internal oblique muscle), after a 0.5-1 ml test dose, the location of the needle was fixed and frequently aspirated and applied to the bilateral neurophysical plan so that 20 ml of 0.25% bupivacaine (Marcaine® 0.5%, Astra Zeneca) was applied to one side.

The first group of patients were awakened after TAP block treatment and reversal of muscle relaxant with atropine sulphate and neostigmine; the control group was awakened after reversal of muscle relaxant with atropine sulphate and neostigmine at the end of the operation. When VAS>3 in the postoperative period, 1g of paracetamol was administered as an intravenous infusion over 10 minutes in terms of the first analgesic requirement.

Systolic and diastolic arterial pressures, heart rate of all patients were monitored immediately before and postoperatively at 30th minute and 1st, 2nd, 4th, 6th, 12th and 24th hours after block administration. The pain levels of the patients were measured at the 30th minute, 1st, 2nd, 4th, 6th, 12th and 24th postoperative VAS values. The need for nausea, vomiting, and initial analgesia was recorded. In this study, none of the patients underwent any invasive procedures other than routine procedures.

When parametric test counts were fulfilled (Kolmogorov-Simirnov) by uploading the data obtained from our study to SPSS (ver:22.0) program, significance test of the difference between the two averages, variance analysis in repeated measurements, Bonferroni test, Mann Whitney U test, Wilcoxon test, Freidman test and Chi-square test were used when parametric test assumptions were not fulfilled. When α is taken as 0.05, β: 0.10, 1-β: 0.90, 25 individuals were included in each group and the strength of the test was p= 0.90388.

Our data were reported as arithmetic mean, standard deviation, number of individuals and the level of error was taken as 0.05.

Being tested
transversus abdominis plane (TAP) block
Keywords
TAP block, postoperative pain, Bupivacaine, ultra sound guided regional anesthesia
Medical subject headings
Postoperative Complications, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transversus abdominis plane (TAP) blockProcedure or surgery

    Also called General Anesthesia

    The transversus abdominis plane (TAP) block is a regional anesthesia technique described in recent years that provides analgesia for the anterior portion of the abdominal wall after abdominal surgery.

Study groups in NCT04364477
Study groupRoleWhat they receive
Tap block GroupActive comparatorTap Block group :(Group 1) After General anestehesia At the end of the operation, TAP blocks were placed to the 1st group patients.
Receives: Procedure: transversus abdominis plane (TAP) block
Control GroupPlacebo comparatorNo block applied. only General anesthesia was applied.
Receives: Procedure: transversus abdominis plane (TAP) block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale of patients

    Pain scale

    Measured: 0-30 minutes

  2. Sistolic Blood Pressure of patients

    Sistolic Blood Pressure

    Measured: 0-30 minutes

  3. Need For Analgesic drugs for post-op patients

    Analgesic need

    Measured: 0-60 minutes

  4. patients with nausea

    post op nausea

    Measured: 0-60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start4 Jan 2015
  3. Primary completion4 Jan 2016
  4. Study completion1 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04364477
Sponsor's protocol ID
Other Identifier-2018
Acronym
TAPBLOCK
Status last verified
Apr 2020
First submitted
23 Apr 2020
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing transversus abdominis plane (TAP) block in people with Post-Op Complication and Pain, Postoperative, run by Cumhuriyet University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale of patients (time frame: 0-30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.

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