Clinical trial NCT04345341: 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.
Official title: Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries
Keywords: TAP block , laparoscopy , minimally invasive gynecology
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores for patients randomized to receive the LA-TAP block verses those who do not. We expect that patients will opt to take less break through opioid medication in the LA-TAP block group versus the no TAP block group.

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 following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 \& 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 \& 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?

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 following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 \& 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 \& 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?

Patients will be randomized in two arms , LA-TAP , NO-TAP block . Each patient would fill out the pain score sheet and number of narcotic medications she used in first 24h, 48h and 72 h post operatively .

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: pain scores at 24 hours in LA-TAP and NO TAP block groups
timeFrame: 24 hour post op
measure: Amount and type of opioid consumption , based on Questionnaire's information . between LA-TAP , UG-TAP and No TAP groups at 24 hours post operatively
timeFrame: 24 hour post op
Secondary outcomes:
measure: Numeric pain score (NPS) based on questionnaire's information at 48 hours & 72 hours post operatively , in LA-TAP , UG-TAp and no TAP groups
timeFrame: 48 -72 hour post operative
measure: amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ?
timeFrame: 48 -72 hours post operative
measure: Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op
timeFrame: first 72 hours post operative
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University Obstetrics, Gynecology & Reproductive Sciences
name: Farinaz Seifi, MD, FACOG
role: PRINCIPAL_INVESTIGATOR
References: