Status:
COMPLETED
Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block Compared to Ultrasound-guided TAP Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
Lead Sponsor:
Yale University
Conditions:
the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. ...
Detailed Description
Investigators aim to answer the above questions through the following primary and secondary outcomes: Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours followi...
Eligibility Criteria
Inclusion
- Patients 18 years old and above
- English speaking
- patients with capacity to consent
- Elective laparoscopic and robotic benign genecology cases
- Elective laparoscopy/ robotic hysterectomy
- Elective laparoscopy/robotic myomectomy
- ERAS (enhanced recovery after surgery) protocol applied
Exclusion
- Pregnant women
- patients with positive urine pregnancy test in pre operative
- emergency procedures
- Procedure requiring staging or debulking
- surgeries that convert to laparotomy
- patients with allergy to local/systemic anaesthesia or analgesia
- Inability to undergo normal anesthesia induction process
- ASA III or higher
- history of pain relief medication dependence
- history of substance abuse
- end stage chronic kidney disease
- advanced liver disease
- history of chronic pain
- history of taking opioids or neuropathic agents regularly prior to surgery
- BMI of 50 or over
- skin infections at the site of TAP block injection or port sites.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04345341
Start Date
November 1 2020
End Date
October 15 2023
Last Update
November 18 2023
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06492