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

NCT ID: NCT02132065

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-06-01

Brief 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.

Conditions

Laparoscopic Nephrectomy; TAP Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard pain keller

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

TAP block

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nessn Azawi

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nessn H. Azawi, MD

Role: PRINCIPAL_INVESTIGATOR

Roskilde Hospital, Department of Urology

Locations

Roskilde Hospital

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

SJ-386

Identifier Type: -

Identifier Source: org_study_id