Method Study: Bilateral TAP Block With 24 Hours Infusion

NCT01577940 | Completed Phase 4 DMC

• 2 other identifiers: SM1-PLP-112011-005118-13
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.

Conditions

Postoperative Pain

Keywords

Transversus abdominis plane block; postoperative pain; Postoperative pain management

Outcome Measures

Primary Outcomes (1)

• Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements

  Extent of sensory block using pinprick and ice

  -15 min., 1, 4, 8, 12 and 24 hours following TAP block

Secondary Outcomes (4)

• Heat pain detection threshold (abdomen)

  -15 min., 1, 4, 8, 12 and 24 hours following TAP block

• Heat pain detection threshold (dominant forearm)

  -15 min., 1, 4, 8, 12 and 24 hours following TAP block

• Long Thermal stimulation (abdomen)

  -15 min., 1, 4, 8, 12 and 24 hours following TAP block

• Lung function

  -15 min., 1, 4, 8, 12 and 24 hours following TAP block

Study Arms (2)

Infusion of local anesthetic

EXPERIMENTAL

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.

Procedure: Infusion of ropivacaine

Infusion of saline

PLACEBO COMPARATOR

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.

Procedure: Infusion of saline

Interventions

Infusion of ropivacaine PROCEDURE

TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.

Infusion of local anesthetic

Infusion of saline PROCEDURE

TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

Infusion of saline

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 30 years
• written consent
• ASA 1
• BMI between 18 and 25
• males

You may not qualify if:

• unable to communicate in Danish
• relevant drug allergy
• alcohol or/and drug abuse
• daily intake of prescription pain medication the last 4 weeks
• pain medication in the last 48 hours
• previously operated abdominal

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (2)

HOC, anesthesiology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

HovedOrtoCentret, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Petersen PL, Hilsted KL, Dahl JB, Mathiesen O. Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers. BMC Anesthesiol. 2013 Oct 10;13(1):30. doi: 10.1186/1471-2253-13-30.

  PMID: 24106815 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Pernille L Petersen, MD

  HOC, anesthesiology, Rigshospitalet, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: April 16, 2012
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 4, 2012

Record last verified: 2012-05

Locations

DK (2)