Abdominal Hysterectomy (& Wertheim)NCT02259374
Use of Tap Block in Patients After Hysterectomy
A study testing TAP BLOCK 0.2% ROPIVACAINE and TAP BLOCK 0.4% ROPIVACAINE in people with Abdominal Hysterectomy (& Wertheim), run by Singapore General Hospital.
Trial summary
TAP block performed under ultrasound guidance is used as part of multimodal analgesia to relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission of pain from the site of tissue injury. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Hysterectomy (& Wertheim)
- What is being tested?
- TAP BLOCK 0.2% ROPIVACAINE and TAP BLOCK 0.4% ROPIVACAINE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2015
- 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 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - ASA 1-3
- age 21-60
- undergoing open hysterectomy as planned by the surgeons
- able to provide informed consent. A upper limit age of 60 is chosen because elderly patients may have reduced requirements for analgesia and may be more sensitive to effects of opioids.
Who cannot join
- - chronic pain/ opioid usage
- allergy to study drugs
- BMI>35
- Weight <50
About this study
TAP block performed under ultrasound guidance is used as part of multimodal analgesia to relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission of pain from the site of tissue injury. An important component of the pain experienced by patients after abdominal surgery derives from the abdominal wall incision. The abdominal wall sensory afferents course through the transversus abdominis (neurofascial) plane superficial to the transversus abdominis muscle. Single shot TAP block has been shown to provide pain relief of up to 24h in surgeries involving pfannenstiel incisions, hence a study period of 24h is chosen in patients undergoing hysterectomy.
This study was designed to test the hypothesis that the TAP block, as part of a multimodal analgesic regimen, even at a lower concentration, would provide effective analgesia in the first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.
Read the detailed description
Our study hypothesis is that TAP block performed with 0.2% ropivacaine is not inferior to that using 0.4% ropivacaine.
The primary outcome measure in this study was 24 h morphine consumption. Secondary outcome measures included time to first request for morphine, VAS scores, and side effects associated with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as patient satisfaction.
Our study hypothesis is that TAP block performed with 0.2% ropivacaine 40ml is not inferior to that using 0.4% ropivacaine 40ml, in terms of analgesia in the first 24h.
Primary Objectives Morphine consumption in the first 24h should not differ between the 2 groups by more than 10mg.
Secondary Objectives Secondary objectives are to show that morphine side effects are similar in the two groups if a lower ropivacaine provides similar pain relief as higher concentration. Patient satisfaction is also recorded.
54 patients undergoing hysterectomy will be recruited from SGH.
Criteria for Recruitment and Recruitment Process Patients will be shortlisted from the surgical list the week prior to surgery. Patients seen in the pre anaesthetic assessment clinic will also be invited to take part in the study. A simple history and physical assessment will determine eligibility. Patients fitting the inclusion criteria will be approached for the study with the emphasis that participation is voluntary and refusal to participate will not affect subsequent conduct of anaesthesia or care. Patient's wishes will be respected should she request not to participate
STUDY DESIGN Double blind randomise control trial. Study design is non-inferiority trial testing 0.2% ropivacaine vs 0.4% ropivacaine. Expected 1 year to complete recruitment of 54 patients. All patients are expected to participate in the study for a period of 24h and will be followup during their convalescence in the hospital. There will be no change in scheduling of operation or additional visits for the purpose of the study.
Ultrasound images of the block may be stored in the thumb drive. However, the images will not be linked to patient identifiers. It will be stored in password protected thumb drive and kept in the department under lock and key.
It may be used for illustration if the research is published in a scientific journal.
Randomisation and Blinding Patients will be randomised into of the 2 groups - 0.2% or 0.4% ropivacaine group. The allocation sequence will be generated by a random number table, and group allocation will be concealed in sealed, opaque envelopes, which will not be opened until just prior to block performance.
The anaesthesiologist performing the block and anaesthesia will not be blinded. However, the patient, surgeon and researcher collecting subsequent patient data will be blinded.
Randomisation code will be broken after the final analysis of the study results. As both study groups involve the use of ropivacaine at concentration below the maximum recommended dose, the likelihood of needing to break the randomisation code is low. However, should that become necessary, the study PI can break the code.
Study Visits and Procedures Study visit 1: recruitment during pre-anaesthesia visit a day before surgery Procedure: Bilateral TAP block after surgery, before reversal of anaesthesia. Followup for 24h, which includes 1 study visit to elicit pain scores and side effects of opioids.
Screening Visits and Procedures History and physical examination are required to evaluate recruitment criteria. Patients will be invited to participate in the study after meeting inclusion criteria.
Study Visits and Procedures
1 visit in the post operative period.
Final Study Visit:
Patient will be seen once after operation in the first post operative day to assess for VAS scores, and side effects associated with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as patient satisfaction.
Post Study Follow up and Procedures Patient will be seen once after operation in the first post operative day to assess for VAS scores, and side effects associated with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as patient satisfaction.
- Conditions
- Abdominal Hysterectomy (& Wertheim)
- Being tested
- TAP BLOCK 0.2% ROPIVACAINE, TAP BLOCK 0.4% ROPIVACAINE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BLOCK 0.2% ROPIVACAINEProcedure or surgery
Patients randomised to this group will receive 20 ml 0.2% Ropivacaine for bilateral TAP block after hysterectomy
TAP BLOCK 0.4% ROPIVACAINEProcedure or surgery
Patients randomised to this group will receive 20 ml 0.4% Ropivacaine for bilateral TAP block after hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| TAP BLOCK 0.2% ROPIVACAINE | Active comparator | Patients randomised into this group will receive bilateral TAP block (single shot) with 0.2% ropivacaine after hysterectomy.
Intervention: TAP block Dose: 20 ml 0.2% ropivacaine Receives: Procedure: TAP BLOCK 0.2% ROPIVACAINE; Procedure: TAP BLOCK 0.4% ROPIVACAINE |
| TAP BLOCK 0.4% ROPIVACAINE | Active comparator | Patients randomised into this group will receive bilateral TAP block (single shot) with 0.4% ropivacaine after hysterectomy.
Intervention: TAP block Dose: 20 ml 0.4% ropivacaine Receives: Procedure: TAP BLOCK 0.2% ROPIVACAINE; Procedure: TAP BLOCK 0.4% ROPIVACAINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in the first 24 hours
Measured: 24hours
Secondary outcomes (2)
Morphine side effects
Measured: 24 hours
Patient satisfaction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Hysterectomy (& Wertheim)Studies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, thong sze ying, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259374
- Sponsor's protocol ID
- 2014/729/D
- Status last verified
- Oct 2014
- First submitted
- 30 Sep 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tap Block in Patients After Hysterectomy
- ClinicalTrials.gov ID
- NCT02259374
- Acronym / sponsor ID
- 2014/729/D
- Conditions
- Abdominal Hysterectomy (& Wertheim)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 8 Oct 2014 (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.
TAP block performed under ultrasound guidance is used as part of multimodal analgesia to relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission of pain from the site of tissue injury. An important component of the pain experienced by patients after abdominal surgery derives from the abdominal wall incision. The abdominal wall sensory afferents course through the transversus abdominis (neurofascial) plane superficial to the transversus abdominis muscle. Single shot TAP block has been shown to provide pain relief of up to 24h in surgeries involving pfannenstiel incisions, hence a study period of 24h is chosen in patients undergoing hysterectomy.
This study was designed to test the hypothesis that the TAP block, as part of a multimodal analgesic regimen, even at a lower concentration, would provide effective analgesia in the first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.
Detailed description
Our study hypothesis is that TAP block performed with 0.2% ropivacaine is not inferior to that using 0.4% ropivacaine.
The primary outcome measure in this study was 24 h morphine consumption. Secondary outcome measures included time to first request for morphine, VAS scores, and side effects associated with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as patient satisfaction.
Our study hypothesis is that TAP block performed with 0.2% ropivacaine 40ml is not inferior to that using 0.4% ropivacaine 40ml, in terms of analgesia in the first 24h.
Primary Objectives Morphine consumption in the first 24h should not differ between the 2 groups by more than 10mg.
Secondary Objectives Secondary objectives are to show that morphine side effects are similar in the two groups if a lower ropivacaine provides similar pain relief as higher concentration. Patient satisfaction is also recorded.
54 patients undergoing hysterectomy will be recruited from SGH.
Criteria for Recruitment and Recruitment Process Patients will be shortlisted from the surgical list the week prior to surgery. Patients seen in the pre anaesthetic assessment clinic will also be invited to take part in the study. A simple history and physical assessment will determine eligibility. Patients fitting the inclusion criteria will be approached for the study with the emphasis that participation is voluntary and refusal to participate will not affect subsequent conduct of anaesthesia or care. Patient's wishes will be respected should she request not to participate
STUDY DESIGN Double blind randomise control trial. Study design is non-inferiority trial testing 0.2% ropivacaine vs 0.4% ropivacaine. Expected 1 year to complete recruitment of 54 patients. All patients are expected to participate in the study for a period of 24h and will be followup during their convalescence in the hospital. There will be no change in scheduling of operation or additional visits for the purpose of the study.
Ultrasound images of the block may be stored in the thumb drive. However, the images will not be linked to patient identifiers. It will be stored in password protected thumb drive and kept in the department under lock and key.
It may be used for illustration if the research is published in a scientific journal.
Randomisation and Blinding Patients will be randomised into of the 2 groups - 0.2% or 0.4% ropivacaine group. The allocation sequence will be generated by a random number table, and group allocation will be concealed in sealed, opaque envelopes, which will not be opened until just prior to block performance.
The anaesthesiologist performing the block and anaesthesia will not be blinded. However, the patient, surgeon and researcher collecting subsequent patient data will be blinded.
Randomisation code will be broken after the final analysis of the study results. As both study groups involve the use of ropivacaine at concentration below the maximum recommended dose, the likelihood of needing to break the randomisation code is low. However, should that become necessary, the study PI can break the code.
Study Visits and Procedures Study visit 1: recruitment during pre-anaesthesia visit a day before surgery Procedure: Bilateral TAP block after surgery, before reversal of anaesthesia. Followup for 24h, which includes 1 study visit to elicit pain scores and side effects of opioids.
Screening Visits and Procedures History and physical examination are required to evaluate recruitment criteria. Patients will be invited to participate in the study after meeting inclusion criteria.
Study Visits and Procedures
1 visit in the post operative period.
Final Study Visit:
Patient will be seen once after operation in the first post operative day to assess for VAS scores, and side effects associated with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as patient satisfaction.
Post Study Follow up and Procedures Patient will be seen once after operation in the first post operative day to assess for VAS scores, and side effects associated with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP BLOCK 0.2% ROPIVACAINE | Active comparator | Procedure: TAP BLOCK 0.2% ROPIVACAINE, Procedure: TAP BLOCK 0.4% ROPIVACAINEPatients randomised into this group will receive bilateral TAP block (single shot) with 0.2% ropivacaine after hysterectomy. Intervention: TAP block Dose: 20 ml 0.2% ropivacaine |
| TAP BLOCK 0.4% ROPIVACAINE | Active comparator | Procedure: TAP BLOCK 0.2% ROPIVACAINE, Procedure: TAP BLOCK 0.4% ROPIVACAINEPatients randomised into this group will receive bilateral TAP block (single shot) with 0.4% ropivacaine after hysterectomy. Intervention: TAP block Dose: 20 ml 0.4% ropivacaine |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - ASA 1-3
- age 21-60
- undergoing open hysterectomy as planned by the surgeons
- able to provide informed consent. A upper limit age of 60 is chosen because elderly patients may have reduced requirements for analgesia and may be more sensitive to effects of opioids.
Key exclusion criteria (4 listed)
- - chronic pain/ opioid usage
- allergy to study drugs
- BMI>35
- Weight <50
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 |
|---|---|---|
| TAP BLOCK 0.2% ROPIVACAINEPatients randomised to this group will receive 20 ml 0.2% Ropivacaine for bilateral TAP block after hysterectomy | Procedure or surgery | TAP BLOCK 0.2% ROPIVACAINE, TAP BLOCK 0.4% ROPIVACAINE |
| TAP BLOCK 0.4% ROPIVACAINEPatients randomised to this group will receive 20 ml 0.4% Ropivacaine for bilateral TAP block after hysterectomy | Procedure or surgery | TAP BLOCK 0.2% ROPIVACAINE, TAP BLOCK 0.4% ROPIVACAINE |
Primary outcome
Morphine consumption in the first 24 hours
Time frame: 24hours
2 secondary outcomes
Morphine side effects
Time frame: 24 hours
Patient satisfaction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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.
Questions about this trial
What is this clinical trial studying?
A study testing TAP BLOCK 0.2% ROPIVACAINE and TAP BLOCK 0.4% ROPIVACAINE in people with Abdominal Hysterectomy (& Wertheim), run by Singapore General Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Morphine consumption in the first 24 hours (time frame: 24hours). 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 8 Oct 2014.