Comparison of Administation Routes of Ropivacaine

NCT04459026 | Completed Phase 4

• 1 other identifier: ropivacaine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of different routes of local anaesthesia administration in laparoscopic procedures to reduce post-operative pain (intra-peritoneal infusion of Ropivacaine 0.75%, port site injection of Ropivacaine 0.75% or a combination of both techniques), through a randomized one-center double-blinded study.

Conditions

Postoperative Pain

Keywords

ropivacaine; laparoscopy

Outcome Measures

Primary Outcomes (2)

• Abdominale Pain scores postoperatively

  Numeric rating scale NRS

  one week

• need of pain medication postoperatively

  note in file

  one week

Secondary Outcomes (5)

• postoperative nausea and vomiting

  one week

• shoulder pain postoperatively

  one week

• itching postoperatively

  one week

• problems with urinating postoperatively

  one week

• Activity level postoperatively: return to normal

  one week

Study Arms (3)

group A - combination

EXPERIMENTAL

Group A patients will receive intra-abdominal instillation 0.75% Ropivacaine 2 mg / kg in 200 ml of NaCl through the trocars and 2) Infiltration of the surgical wounds at the trocar sites with 0.75% Ropivacaine 1 mg / kg in 20 ml of NaCl

Procedure: combination

Group B - infiltration

EXPERIMENTAL

Group B patients will receive infiltration of the surgical wounds at the trocar sites with 0.75% Ropivacaine 3 mg / kg in 20 ml of NaCl.

Procedure: infiltration

Group C - instillation

ACTIVE COMPARATOR

Group C patients will receive intra-abdominal instillation 0.75% Ropivacaine 3 mg / kg in 200 ml of NaCl through the trocars.

Procedure: instillation

Interventions

combination PROCEDURE

instillation and infiltration of ropivacaine

Also known as: ropivacaine intraperitoneal and local

group A - combination

infiltration PROCEDURE

local infiltration ropivacaine

Also known as: ropivacaine local

Group B - infiltration

instillation PROCEDURE

intraperitoneal ropivacaine instillation

Also known as: intraperitoneal ropivacaine

Group C - instillation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective gynecologic laparoscopy for benign conditions at Antwerp University Hospital.
• Successful laparoscopy without surgical or anesthetic complications.
• Female
• years
• ASA I-II

You may not qualify if:

• Hypersensitivity to anaesthetics of the amide-type
• Obesity, BMI \> 35
• Patients with chronic use of analgesics / chronic pain
• Patients with an abnormal liver function
• Urgent surgical procedures
• Pregnancy (this means we only include patients who use contraceptives, are sterilized, have a negative dipstick testing or a negative serum testing or patients who are postmenopausal)

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

UZA

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant won't know to what study group they are assigned and will be under general anaesthesia. The study medication will be prepared in the operating room right before use. This means that neither the anaesthesiologist nor the surgeon, performing the surgery, are blinded. The investigators filling in the questionnaires, the patients or the nurses of the recovery room will always be blinded to the study groups, as will the nurse contacting the patients for the follow up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Jacquemyn

Model Details: We will be using ropivacaine - naropin 7,5mg/ml, a local anaesthetic of the amide type. The administered dose of this local anaesthetic will be 3mg/kg for each patient. Depending on the study group the patient belongs to, this dose will be given in full by either local injection at the trocar entry points or by intraperitoneal injection or it will be divided between both injection sites

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: July 7, 2020
• Study Start: July 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: February 29, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

BE (1)