ESP Block VS TAP in Laparoscopic Hysterectomy

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).

Clinical Trial Description

For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected. [10] For the ESP block, as mentioned previously, the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected. All patients will receive PO acetaminophen and PO gabapentin the morning of surgery. Pt. will be placed on PRN oxycodone/acetaminophen (Percocet) postoperatively. PRN IV dilaudid may be given for severe breakthrough pain. Opioid usage at 1, 24 and 48 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24 and 48 hours after the blocks and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded. ;

Study Design

Related Conditions & MeSH terms

Hysterectomy

Clinical Trial Details

NCT number	NCT04003987
Study type	Interventional
Source	Indiana University
Contact
Status	Completed
Phase	Phase 3
Start date	May 1, 2019
Completion date	March 4, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05337566` - Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections	N/A
Recruiting	`NCT04130464` - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management	Phase 4
Recruiting	`NCT05537727` - Robotic MIS With Dexter
Completed	`NCT05037383` - Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions	N/A
Completed	`NCT04080323` - Single-dose Vaginal Dinoprostone and Hysterectomy	Phase 3
Not yet recruiting	`NCT06011538` - Web-based Versus Standard Information for Same Day Hysterectomy (WISH)	N/A
Completed	`NCT03187327` - Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology	N/A
Terminated	`NCT00551785` - Surveillance Study of Women Taking Intrinsa®	Phase 4
Completed	`NCT00528177` - Morphine vs. Oxycodone for Postoperative Pain Management	Phase 4
Completed	`NCT03641625` - Effect of SmtO2 Guided Care on PONV (iMODIPONV)	N/A
Terminated	`NCT03500744` - Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery	N/A
Recruiting	`NCT03294343` - Risk-Reducing Surgeries for Hereditary Ovarian Cancer	N/A
Completed	`NCT03610425` - A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
Completed	`NCT05659303` - Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy
Completed	`NCT05270447` - Short-Term Effects of Connective Tissue Massage After Hysterectomy	N/A
Recruiting	`NCT05031182` - Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.	N/A
Completed	`NCT03634306` - Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy	N/A
Completed	`NCT01526668` - Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy	N/A
Recruiting	`NCT05374720` - Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy	N/A
Recruiting	`NCT04109989` - Clinical Assessment - HominisTM Surgical System	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.