The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study is conducted to evaluate different analgesic treatments effect following operation where the prostate gland is surgically removed.
The different treatments the investigators wish to investigate is:
Transversus Abdominis Plane (TAP) block.
The TAP block is a rather new method, where a local anaesthetic is deposited between the two inner abdominal muscles. Between these muscles, the nerves that innervates the anterior part of the abdominal wall is situated.
Wound infiltration
In this method you deposit a local anaesthetic in the edges of the wound.
- Placebo
No active local treatment is given.
All patients who wish to participate will be allocated to one of three different treatment groups.
Group 1:
Will receive TAP block with a local anaesthetic and wound infiltration with saline.
Group 2:
Will receive wound infiltration with a local anaesthetic and TAP block with saline.
Group 3:
Will receive TAP block with saline and wound infiltration with saline.
Beside this local treatment all patients will be given systemic Paracetamol (tablet) and Ibuprofen (tablet).
In addition all patients will be given a pump containing morphine. The pump is connected to a button which the patient can activate when they experience pain. This enables the patient to control how much morphine he needs, following the operation.
The hypothesis is that the TAP block is superior in reducing pain and thereby reducing morphine consumption compared to wound infiltration and placebo.
| Condition | Intervention |
|---|---|
|
Postoperative Pain |
Drug: Naropine Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Versus Wound Infiltration Versus Placebo Following Open Radical Prostatectomy, a Double Blinded, Randomized Clinical Trial |
- A mean visual analogue scale (VAS) pain score 4 hours after surgery when moving from a supine to sitting position between the group receiving active TAP block and the placebo group. [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]
- VAS pain score at rest, recorded as a Area Under Curve (AUC/24h) [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]
This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative, while the patient is supine in his bed.
This outcome is recorded in and compared between all three groups.
- VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h) [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]This outcome is assessed 1, 2, 4, 6, 8, 20 and 24 hours postoperative. This outcome is recorded in and compared between all three groups.
- Nausea [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]
On a scale ranging none-mild-moderate-severe at 1, 2, 4, 6, 8, 20, 24 hours postoperative.
This outcome is recorded in and compared between all three groups
- Sedation [ Time Frame: Recorded at 0-24 hours postoperative ] [ Designated as safety issue: No ]
On a scale ranging none-mild-moderate-severe this outcome is assessed at 1, 2, 4, 6, 8, 20 and 24 hours postoperative.
This outcome is recorded in and compared between all three groups.
- Vomiting [ Time Frame: Recorded 0-24 hours postoperative ] [ Designated as safety issue: No ]The number of times the patient produces more than 10 mL of vomit. Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded in and compared between all three groups
- On-going morphine consumption [ Time Frame: Recorded 0-24 postoperative ] [ Designated as safety issue: No ]Recorded at the intervals 0-1, 1-2, 2-4, 4-6, 6-8, 8-20 and 20-24 hours postoperative This outcome is recorded and compared between all three groups
- Cumulated morphine consumption [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]This outcome is recorded in and compared between all three groups.
| Enrollment: | 75 |
| Study Start Date: | March 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: TAP block
TAP block with Ropivacaine Wound infiltration with Saline |
Drug: Naropine
20 mL of 0,75% Naropin is deposited on each side (40 mL in total) in the TAP. At the same time 40 mL of saline 0,9% will be deposited subcutaneously as wound infiltration. Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once. Other Names:
|
|
Active Comparator: Wound infiltration
TAP block with Saline. Wound infiltration with Ropivacaine. |
Drug: Naropine
20 mL Saline 0,9% is deposited on each side (40 mL in total) in the TAP. At the same time 40 mL Ropivacaine 0,75% will be deposited subcutaneously as wound infiltration. Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once. Other Names:
|
|
Placebo Comparator: Placebo
TAP block with Saline. Wound infiltration with Saline. |
Other: Placebo
20 mL 0,9% Saline is deposited on each side (40 mL in total) in the TAP. At the same time 40 mL Saline 0,9% will be given as wound infiltration. Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI > 18 and < 35
- Patients who have given their informed consent and have fully understood the nature and limitations of the study
- Patient who is planned for radical prostatectomy
Exclusion Criteria:
- Not able to cooperate to complete the study
- Is not able to speak and understand danish
- Allergy towards the drugs which is used in the study
- Daily use of strong opioids
- Infection at the injection area
Contacts and Locations| Denmark | |
| The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet | |
| Copenhagen Ø, Denmark, 2100 | |
| Principal Investigator: | Birgitte Ruhnau, Consultant | Department of Anaesthesiology, Abdominal Centre, Rigshospitalet |
More Information
No publications provided
| Responsible Party: | Birgitte Ruhnau, Consultant, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01317368 History of Changes |
| Other Study ID Numbers: | SM1-AS-2010, 2010-024153-36 |
| Study First Received: | March 11, 2011 |
| Last Updated: | June 19, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: The Danish Medicines Agency Denmark: The Danish Data Protection Agency Denmark: The Good Clinical Practice (GCP) Unit at Copenhagen University |
Keywords provided by Rigshospitalet, Denmark:
|
Postoperative analgesic treatment TAP block Prostatectomy Double blinded randomized clinical trial |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Analgesics Ropivacaine Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Local Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 22, 2013