The Efficacy of Surgical Site Treatment With Ropivacaine in Laparoscopic Surgery

Pain Clinical Trial

Official title:

Local Analgesia in Laparoscopic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02826876
• Other study ID #: 0196-15-NHR
• Status: Not yet recruiting
• Phase: N/A
• First received: June 22, 2016
• Last updated: July 5, 2016
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Western Galilee Hospital-Nahariya
• Contact: Moaad H Farraj, Dr
• Phone: 0507887996
• Email: moaad.farraj[@]naharia.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.

Description:

At the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Laparoscopic bariatric surgery

• Laparoscopic inguinal hernia surgery

Exclusion Criteria:

• Cardiac arrythmias

• Active ischemic heart disease

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Topical use
Topical use of Ropivacaine in laparoscopic surgery

Other:
• laparoscopic repair of inguinal hernia
intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia
• laparoscopic bariatric surgery
intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery

Locations

Country	Name	City	State
Israel	Naharia Medical Center	Naharia

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale as measured by pain scale questionnaire	post operative pain intensity will be assisted by VAS(visual analog pain scale) scale at fixed times after surgery	1 Week	No
Secondary	Reducing use of narcotics according to nurse records	patients will be treated by standard analgetic protocol, the records of analgetic drugs will be collected during patients hospitalization	1 Week	No