Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

Robotic Assisted Laparoscopic Surgery Clinical Trial

Official title:

A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01760161
• Other study ID #: 20120042
• Status: Terminated
• Phase: N/A
• First received: December 19, 2012
• Last updated: May 11, 2015
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2015
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

Description:

After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.

The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.

Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.

The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for robotic assisted laparoscopis surgery

• acceptance to participate

Exclusion Criteria:

• allergies to local analgetics

• daily use of strong opioids

Study Design

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

Related Conditions & MeSH terms

• Bilateral Dual Transversus Abdominis Plane Block
• Pain Treatment
• Robotic Assisted Laparoscopic Surgery

Intervention

Drug:
• Ropivacaine
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
• Isotonic potassium chloride
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.

Locations

Country	Name	City	State
Denmark	Aalborg Hospital	Aalborg	Region Nord

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thermoanalgesia at dermatome-level th6-th12		1 hour after bilateral dual transversus abdominis plane block	No
Other	Plasma-ropivacain level		15, 30, 60, 120 and 240 mins after the block	Yes
Primary	Pain-score on numerical rating scale		4 hours after surgery	No
Secondary	Administration of opioids		The first 24 hours after surgery.	No
Secondary	Pain-score on numerical rating scale		8 hours after surgery	No
Secondary	Pain-score on numerical rating scale		24 hours after surgery	No