Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures

NCT ID: NCT03536741

Last Updated: 2018-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2018-07-12

Brief Summary

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The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of LOS (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.

Detailed Description

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Conditions

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TAP and RS Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ALR

Group Type EXPERIMENTAL

TAP block and RS block + General Intravenous Anesthestic

Intervention Type PROCEDURE

transversus abdominis plane block and rectus sheath block

EV

Group Type ACTIVE_COMPARATOR

General Intravenous Anesthetic

Intervention Type DRUG

General Intravenous Anesthetic

Interventions

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TAP block and RS block + General Intravenous Anesthestic

transversus abdominis plane block and rectus sheath block

Intervention Type PROCEDURE

General Intravenous Anesthetic

General Intravenous Anesthetic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing benign laparoscopic gynecological surgery
* age between 18 and 75 years
* BMI \>18 e \<35
* ECOG Performance Status 0-1

Exclusion Criteria

* age \< 18 or \> 75 years
* BMI \<18 or \> 35
* ECOG Performance Status \>1
* Allergy to local anesthetics
* Allergy to NSAIDs
* Chronic kidney failure \> II class
* Systemic neoplastic disease actual or previous
* Actual pregnancy
* Active or recent pelvic inflammation
* Persistent coagulopathy
* Previous opioids consumption for chronic pain
* Neurological or cognitive disorders
* Conversion from laparoscopic to open surgery
* Onset of intraoperative complications
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Corrado Terranova

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Campus Bio-medico

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Corrado Terranova

Role: primary

06225411203

Other Identifiers

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GIN-TAP 2017

Identifier Type: -

Identifier Source: org_study_id

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