Yale University
New Haven, Connecticut, 06492, United States
Completed
NCT Number: 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.
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?
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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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 .
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
TAP block with liposomal bupivacaine and bupivacaine
Druginjecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves
Primary outcomes
-
pain scores at 24 hours in LA-TAP and NO TAP block groups
Time frame: 24 hour post op
numeric pain score (NPS)pain scores at 24 hours will include the average pain score at rest reported by the patient in the first 24 hours.
-
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
Time frame: 24 hour post op
MME will be calculated as the cumulative amount of opioid intake in the 24 hours following anesthesia end time.
Secondary outcomes
-
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
Time frame: 48 -72 hour post operative
numeric pain score (NPS)
-
amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ?
Time frame: 48 -72 hours post operative
morphine equivalent dose of narcotic use
-
Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op
Time frame: first 72 hours post operative
nausea and vomiting, yes or no .
Sponsors and collaborators
Lead sponsor
Yale University
Other
Registry information
Official study title
Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
Acronym: TAP
Important dates
- Study start
- 2020
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Apr 14, 2020
- Registry last updated
- Nov 18, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.