HysterectomyPhase 4NCT01552148
Transversus Abdominis Plane Block for Laparoscopic Hysterectomy
A Phase 4 study testing USguided bilateral TAP block in people with Hysterectomy and Laparoscopic Surgery, run by Istituti Ospitalieri di Cremona at 1 site in Italy.
Trial summary
Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine requirements during the first 24 hours postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hysterectomy, Laparoscopic Surgery
- What is being tested?
- USguided bilateral TAP block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Mar 2013
- Phase
- Phase 4
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years < age < 70 years
- ASA I - II - III
- undergoing elective laparoscopic hysterectomy
- signed informed consent
Who cannot join
- chronic therapy with opioids/ antidepressants
- surgical conversion to open abdominal hysterectomy
- urgent/emergent surgery
- postoperative transfer to the intensive care unit
- pregnancy or breast feeding
- known allergy to any drug medication
Show all 12Show fewer
- local skin infection
- epilepsy
- high bilirubin level (> 3mg/dl) or high hepatic enzymes levels (> 250UI)
- high creatinin level (> 1.4mg/dl)
- 18Kg/m2 < BMI < 30Kg/m2
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, 26100
About this study
Official title: Randomized, Controlled, Observer-blinded Study on the Efficacy of TAP Block With 0.375% Levobupivacaine in Terms of PCA Morphine Postoperative Consumption in Patients Undergoing Laparoscopic Hysterectomy
Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine requirements during the first 24 hours postoperatively.
Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:
Read more
- Group treatment TAP (n=23) will receive the following analgesia:
- US guided transversus abdominis plane block performed with 40ml of 0.375% levobupivacaine (20 ml per side) after general anaesthesia induction, before surgical start
- Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest
- Group control will receive:
- Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest
Primary Outcome Measures:
Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control
Secondary Outcome Measures:
- Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain when resting in bed and during cough during the first 24 hours postoperatively
- Time to PACU dimission, evaluated as patient's achievement of a White's score > or = 12/14
- Time to home discharge, evaluated as patient's achievement of a PADDS score > or = 9
- Functional patient capacity as measured before surgery and whenever a White's score > or = 12 will be reached (2minute walking test)
- Eventual side effects such as nausea/vomiting
Read the detailed description
After the start of the study, we had a higher drop out size than expected. We therefore added a 13% of patient to initial power calculation to compensate for drop outs.
Total number of patients enrolled = 52 (46 + 6) Total number of patients who completed the study = 44
- Conditions
- Hysterectomy, Laparoscopic Surgery
- Being tested
- USguided bilateral TAP block, Morphine Patient Controlled Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USguided bilateral TAP blockOther
23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start
Morphine Patient Controlled AnalgesiaDrug
Morphine PCA i.v. (bolus 2mg, lockout 8 min)
Morphine Patient Controlled AnalgesiaDrug
Morphine PCA i.v. (bolus 2mg, lockout 8min)
| Study group | Role | What they receive |
|---|---|---|
| Group TAP (US guided) | Active comparator | 23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start Receives: Other: USguided bilateral TAP block; Drug: Morphine Patient Controlled Analgesia |
| Group Control | Other | Not described Receives: Drug: Morphine Patient Controlled Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCA morphine consumption in the two groups within the first 24 postoperative hours
Measured: 24 hours postoperatively
Secondary outcomes (5)
Numerical Rating Scores for pain at rest and during movement
Measured: 24 hours postoperatively
Time to discharge from Recovery Room
Time to achieve a White's score > or = 12
Measured: 24 hours postoperatively
time to discharge from the surgical floor
time to achieve a PADDS score > or = 9
Measured: 24 hours postoperatively
evaluation of patients' functional capacity postoperatively versus baseline
2-minute walking test assessed as soon as a White's score > or = 12 has been reached or every 30minutes until patient is capable to walk
Measured: 24 hours postoperatively
postoperative nausea/vomiting incidence
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Ospitalieri di Cremona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Danelli, Istituti Ospitalieri di Cremona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552148
- Sponsor's protocol ID
- 5504/2012LD
- Status last verified
- Feb 2014
- First submitted
- 6 Mar 2012
- Last updated
- 17 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Observer-blinded Study on the Efficacy of TAP Block With 0.375% Levobupivacaine in Terms of PCA Morphine Postoperative Consumption in Patients Undergoing Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT01552148
- Acronym / sponsor ID
- 5504/2012LD
- Conditions
- Hysterectomy, Laparoscopic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istituti Ospitalieri di CremonaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Mar 2012 (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.
Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine requirements during the first 24 hours postoperatively.
Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:
- Group treatment TAP (n=23) will receive the following analgesia:
- US guided transversus abdominis plane block performed with 40ml of 0.375% levobupivacaine (20 ml per side) after general anaesthesia induction, before surgical start
- Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest
- Group control will receive:
- Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest
Primary Outcome Measures:
Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control
Secondary Outcome Measures:
- Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain when resting in bed and during cough during the first 24 hours postoperatively
- Time to PACU dimission, evaluated as patient's achievement of a White's score > or = 12/14
- Time to home discharge, evaluated as patient's achievement of a PADDS score > or = 9
- Functional patient capacity as measured before surgery and whenever a White's score > or = 12 will be reached (2minute walking test)
- Eventual side effects such as nausea/vomiting
Detailed description
After the start of the study, we had a higher drop out size than expected. We therefore added a 13% of patient to initial power calculation to compensate for drop outs.
Total number of patients enrolled = 52 (46 + 6) Total number of patients who completed the study = 44
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TAP (US guided) | Active comparator | Other: USguided bilateral TAP block, Drug: Morphine Patient Controlled Analgesia23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start |
| Group Control | Other | Drug: Morphine Patient Controlled Analgesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years < age < 70 years
- ASA I - II - III
- undergoing elective laparoscopic hysterectomy
- signed informed consent
Key exclusion criteria (12 listed)
- chronic therapy with opioids/ antidepressants
- surgical conversion to open abdominal hysterectomy
- urgent/emergent surgery
- postoperative transfer to the intensive care unit
- pregnancy or breast feeding
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 |
|---|---|---|
| USguided bilateral TAP block23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start | Other | Group TAP (US guided) |
| Morphine Patient Controlled AnalgesiaMorphine PCA i.v. (bolus 2mg, lockout 8 min) | Drug | Group TAP (US guided) |
| Morphine Patient Controlled AnalgesiaMorphine PCA i.v. (bolus 2mg, lockout 8min) | Drug | Group Control |
Primary outcome
PCA morphine consumption in the two groups within the first 24 postoperative hours
Time frame: 24 hours postoperatively
5 secondary outcomes
Numerical Rating Scores for pain at rest and during movement
Time frame: 24 hours postoperatively
Time to discharge from Recovery Room
Time frame: 24 hours postoperatively
time to discharge from the surgical floor
Time frame: 24 hours postoperatively
evaluation of patients' functional capacity postoperatively versus baseline
Time frame: 24 hours postoperatively
postoperative nausea/vomiting incidence
Time frame: 24 hours postoperatively
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 17 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing USguided bilateral TAP block in people with Hysterectomy and Laparoscopic Surgery, run by Istituti Ospitalieri di Cremona at 1 site in Italy.
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 4 inclusion and 12 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 17 Feb 2014. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
PCA morphine consumption in the two groups within the first 24 postoperative hours (time frame: 24 hours postoperatively). 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 17 Feb 2014.