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Trocar-site Infiltration Versus TAP-block

NCT ID: NCT05094193

Last Updated: 2021-10-26

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-01-31

Brief Summary

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For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Keywords

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Acute pain management Ropivacaine Trocar-site infiltration TAP-block Laparoscopic cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Trocar-site infiltration

Trocar-site infiltration with 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 5 mm trocar site) associated with bilateral TAP block with 20 mL of normal saline in each side

Group Type EXPERIMENTAL

Trocar-site infiltration

Intervention Type PROCEDURE

20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)

TAP block placebo

Intervention Type PROCEDURE

bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side

TAP block

Trocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side

Group Type ACTIVE_COMPARATOR

TAP block

Intervention Type PROCEDURE

bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side

Trocar site infiltration placebo

Intervention Type PROCEDURE

20 mL of normal saline

Interventions

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Trocar-site infiltration

20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)

Intervention Type PROCEDURE

TAP block

bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side

Intervention Type PROCEDURE

Trocar site infiltration placebo

20 mL of normal saline

Intervention Type PROCEDURE

TAP block placebo

bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \< 30 kg/m2
* Scheduled for laparoscopic cholecystectomy
* ASA grade I, II and III

Exclusion Criteria

* Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis
* Conversion to open cholecystectomy or if the surgery exceeded 200 minutes
* Severe systemic disease
* Patients on analgesics for any reason
* History of allergy to local anesthetics
* An ongoing pregnancy
* Patient refusal
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tunis University

OTHER

Sponsor Role lead

Responsible Party

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Daghmouri Mohamed Aziz

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BEN FADHEL Kamel, M.D

Role: STUDY_DIRECTOR

Habib Thameur Hospital of Tunis, Department of Anesthesia

Locations

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Habib Thameur Hospital

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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DAGHMOURI Mohamed Aziz, M.D

Role: CONTACT

Phone: 0029442474

Email: [email protected]

Facility Contacts

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Mohamed Aziz Daghmouri

Role: primary

Other Identifiers

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HTHEC-2021-29

Identifier Type: -

Identifier Source: org_study_id