Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation

Laparoscopic Nephrectomy Clinical Trial

Official title:

Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132065
• Other study ID #: SJ-386
• Status: Completed
• Phase: N/A
• First received: May 4, 2014
• Last updated: January 22, 2018
• Start date: June 2014
• Est. completion date: June 1, 2017

Study information

• Verified date: January 2018
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy, assessment of benefit and opioid reduction.

Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which infiltrates local anesthetic between the internal oblique and transverse abdominis muscles and provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12) abdominal wall bilaterally using a four-point single-shot technique.

Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain may have harmful physiologic, psychological consequences which potentially increase the morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8).

Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the need of morphine postoperatively after radical nephrectomy.

Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to routine analgesic. To assess the difference in morphine usage in the first 48 hours after radical nephrectomy with or without applying of unilaterally dual TAP block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

-Any patient undergoing laparoscopic nephrectomy- -Age ranges 18-80- -Can read and understand Danish- -Able to give informed consent

Exclusion Criteria:

-History of relevant drug allergy- -Inability to understand written consent forms or give consent- -Age less than 18 or over 80- -Any conversion to open surgery-

-Patients included in ambulant nephrectomy project.

Related Conditions & MeSH terms

• Laparoscopic Nephrectomy
• TAP Block

Intervention

Drug:
• TAP block
Patients will be scheduled to receive routine analgesic and an unilaterally dual TAP block with 2 points injections of 15 ml of 0,375 % Ropivacain( in total 30 ml 0,375% Ropivacain) in the same side of nephrectomy.

Locations

Country	Name	City	State
Denmark	Roskilde Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	The use of unilaterally dual TAP block will reduce the VAS score for pain and the need of morphine postoperatively after radical nephrectomy	24 hours