Use of Tap Block in Patients After Hysterectomy
1 other identifier
interventional
54
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 8, 2014
October 1, 2014
1 year
September 30, 2014
October 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Morphine consumption in the first 24 hours
24hours
Secondary Outcomes (2)
Morphine side effects
24 hours
Patient satisfaction
24 hours
Study Arms (2)
TAP BLOCK 0.2% ROPIVACAINE
ACTIVE COMPARATORPatients 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 COMPARATORPatients 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
Interventions
Patients randomised to this group will receive 20 ml 0.2% Ropivacaine for bilateral TAP block after hysterectomy
Patients randomised to this group will receive 20 ml 0.4% Ropivacaine for bilateral TAP block after hysterectomy
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- \- chronic pain/ opioid usage
- allergy to study drugs
- BMI\>35
- Weight \<50
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ASSOCIATE CONSULTANT
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 8, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 8, 2014
Record last verified: 2014-10