Abdominal Hysterectomy (& Wertheim) Clinical Trial
Official title:
Use of Tap Block in Patients After Hysterectomy
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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