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The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy

The Effects of TAP Block on Hemodynamic Variables, Anaesthetic and Analgesic Requirement and Quality of Recovery in Patients Undergoing Total Abdominal Hysterectomy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02296619
Acronym
TAP
Enrollment
66
Registered
2014-11-20
Start date
2014-09-30
Completion date
2016-02-29
Last updated
2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Hysterectomy (& Wertheim), Intraoperative Complications

Brief summary

The purpose of this study is to determine the effects of Transversus Abdominis Plane Block on hemodynamic variables, anaesthetic and analgesic requirement, and quality of recovery in patients undergoing total abdominal hysterectomy

Detailed description

Pain is one of the main causes of the poor perioperative outcomes and pain management is the important part of perioperative period. Neuraxial blocks could provide adequate analgesia during and after abdominal surgery. However,neuraxial blocks have a lot of contraindicated situations and neuraxial anesthesia can easily induce hemodynamic abnormalities. Therefore, in most cases, the choice of anaesthetic management may be the general anesthesia. In addition to reduce the blood pressure and heart rate changes due to surgical stimulations, the large amount of opioids and anaesthetics may be required. Opioid related side effects can affect perioperative complications and postoperative quality of recovery. Transversus abdominis plane block is a new choice to reduce postoperative pain in abdominal surgery. Although its postoperative analgesic efficacy is well known, its effects on hemodynamic variables, anaesthetic and analgesic requirement is not clear. The main objective of this study is to estimate the effect of Transversus abdominis plane block on hemodynamic variables, anaesthetic and analgesic requirement and quality of recovery in patients undergoing total abdominal hysterectomy.

Interventions

PROCEDURETAP block

Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle

PROCEDUREControl

A sham band-aid will be applied to the abdomen of subjects

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adult (18-65years old) * American Society of Anesthesiologists (ASA) physical status I-II * Patients scheduled for elective total abdominal hysterectomy under general anesthesia

Exclusion criteria

* ASA physical status ≥ 3 * Allergy to local anesthetics * Drug abuse or addiction * Bleeding tendency

Design outcomes

Primary

MeasureTime frameDescription
intraoperative opioid consumptionduring anaesthesiaThe overall intravenous remifentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer remifentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.

Secondary

MeasureTime frameDescription
Quality of recoverypostoperative 24 hoursquality of recovery 40 form will use to assessment the recovery
Postoperative nausea and vomitingpostoperative 0.,2.,12.,24 hoursnausea score(0-3) and number of vomiting will be recorded
postoperative painpostoperative 0,2,12,24 hoursvisual analog scale will be used
intraoperative hemodynamic variablesduring anaesthesiaarterial blood pressure, heart rate changes will be recorded
intraoperative anaesthetic consumptionduring anaesthesiaanaesthetic consumption will be calculated

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026