Postoperative PainNCT01317368
The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Following Radical Prostatectomy
A study testing Naropine in people with Postoperative Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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: 1. Transversus Abdominis Plane (TAP) block. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Naropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
Copenhagen Ø, 2100
About this study
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
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:
Read more
- 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.
- Conditions
- Postoperative Pain
- Being tested
- Naropine, Placebo
- Keywords
- Postoperative analgesic treatment, TAP block, Prostatectomy, Double blinded randomized clinical trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaropineDrug
Also called Ropivacaine, TAP block, Wound infiltration, Placebo
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.
NaropineDrug
Also called Ropivacaine, TAP block, Wound infiltration, Placebo
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.
PlaceboOther
Also called Ropivacaine, TAP block, Wound infiltration
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.
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Active comparator | TAP block with Ropivacaine
Wound infiltration with Saline Receives: Drug: Naropine |
| Wound infiltration | Active comparator | TAP block with Saline.
Wound infiltration with Ropivacaine. Receives: Drug: Naropine |
| Placebo | Placebo comparator | TAP block with Saline.
Wound infiltration with Saline. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours postoperative
Secondary outcomes (7)
VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)
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.
Measured: Recorded 0-24 hours postoperative
VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)
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.
Measured: Recorded 0-24 hours postoperative
Nausea
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
Measured: Recorded 0-24 hours postoperative
Sedation
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.
Measured: Recorded at 0-24 hours postoperative
Vomiting
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
Measured: Recorded 0-24 hours postoperative
On-going morphine consumption
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
Measured: Recorded 0-24 postoperative
Cumulated morphine consumption
This outcome is recorded in and compared between all three groups.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitte Ruhnau, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Birgitte Ruhnau, Consultant, Principal investigator, Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317368
- Sponsor's protocol ID
- SM1-AS-2010
- Other IDs
- 2010-024153-36
- Status last verified
- Jun 2012
- First submitted
- 11 Mar 2011
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01317368
- Acronym / sponsor ID
- SM1-AS-2010
- Conditions
- Postoperative Pain
- Keywords
- Postoperative analgesic treatment, TAP block, Prostatectomy, Double blinded randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP block | Active comparator | Drug: NaropineTAP block with Ropivacaine Wound infiltration with Saline |
| Wound infiltration | Active comparator | Drug: NaropineTAP block with Saline. Wound infiltration with Ropivacaine. |
| Placebo | Placebo comparator | Other: PlaceboTAP block with Saline. Wound infiltration with Saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaropineAlso: Ropivacaine, TAP block, Wound infiltration, Placebo20 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. | Drug | TAP block |
| NaropineAlso: Ropivacaine, TAP block, Wound infiltration, Placebo20 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. | Drug | Wound infiltration |
| PlaceboAlso: Ropivacaine, TAP block, Wound infiltration20 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 | Placebo |
Primary outcome
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
7 secondary outcomes
VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)
Time frame: Recorded 0-24 hours postoperative
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
Nausea
Time frame: Recorded 0-24 hours postoperative
Sedation
Time frame: Recorded at 0-24 hours postoperative
Vomiting
Time frame: Recorded 0-24 hours postoperative
On-going morphine consumption
Time frame: Recorded 0-24 postoperative
Cumulated morphine consumption
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitte Ruhnau, Consultant principal investigator
Department of Anaesthesiology, Abdominal Centre, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naropine in people with Postoperative Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.