the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries Clinical Trial
— TAPOfficial title:
Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
| Verified date | November 2023 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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?
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | October 15, 2023 |
| Est. primary completion date | October 15, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Yale University | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pain scores at 24 hours in LA-TAP and NO TAP block groups | 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. | 24 hour post op | |
| Primary | 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 | MME will be calculated as the cumulative amount of opioid intake in the 24 hours following anesthesia end time. | 24 hour post op | |
| Secondary | 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 | numeric pain score (NPS) | 48 -72 hour post operative | |
| Secondary | amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ? | morphine equivalent dose of narcotic use | 48 -72 hours post operative | |
| Secondary | Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op | nausea and vomiting, yes or no . | first 72 hours post operative |