NCT05173090

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

December 29, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 29, 2021

Last Update Submit

December 10, 2021

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

  • Patient's pain

    The patient's satisfaction was assessed by visual analog scale, ranging from one (worse outcome )to four (better outcome

    During appendectomy and cholecystectomy surgery

Study Arms (2)

Ropivacaïne 0,5%

ACTIVE COMPARATOR

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

Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery

NaCl 0,9%

PLACEBO COMPARATOR

NaCl 0,9% sprayed into the abdominal cavity

Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery

Interventions

Ropivacaïne 0,5% for appendectomy or cholecystectomy surgeryDRUG

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%Ropivacaïne 0,5%

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Appendectomy or cholecystectomy surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Benjamin Javillier, MD

CONTACT

+32498573882javillier.benjamin@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 29, 2021

Study Start

January 15, 2022

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

December 29, 2021

Record last verified: 2021-11