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Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.

NCT ID: NCT05173090

Last Updated: 2021-12-29

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2022-07-30

Brief Summary

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Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery.

Detailed Description

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Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Ropivacaïne 0,5%

3 mg/kg of ropivacaine 0.5% sprayed into the abdominal cavity

Group Type ACTIVE_COMPARATOR

Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery

Intervention Type DRUG

Visual analog scale 15 min after arrival in the recovery room, then H+4, H+6, H+12, H+24 and one week after the operation

NaCl 0,9%

NaCl 0,9% sprayed into the abdominal cavity

Group Type PLACEBO_COMPARATOR

Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery

Intervention Type DRUG

Visual analog scale 15 min after arrival in the recovery room, then H+4, H+6, H+12, H+24 and one week after the operation

Interventions

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Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery

Visual analog scale 15 min after arrival in the recovery room, then H+4, H+6, H+12, H+24 and one week after the operation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Appendectomy or cholecystectomy surgery

Exclusion Criteria

* Allergy to local anesthetics
* Intolerance to tramadol HCl
* Patient with peritonitis
* Pregnant women
* Surgery without laparoscopy
* Chronic pain before the operation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Javillier, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Benjamin Javillier, MD

Role: CONTACT

Phone: +32498573882

Email: [email protected]

Other Identifiers

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Ropicoelio

Identifier Type: -

Identifier Source: org_study_id