Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02927405
• Other study ID #: 926072
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 4, 2020
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2021
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. There are no studies that have compared a TAP block versus a TAP block plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin and receiving a TAP block decrease post-operative morphine consumption. It will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because gabapentin will be used to decrease visceral and central pain, and TAP block will decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• female

• receiving laparoscopic GYN procedure

• between 18-60

Exclusion Criteria:

• are already taking gabapentin

• have diabetic neuropathy

• have a chronic pain syndrome

• take opioids at home

• are pregnant

• have kidney disease

• have an allergy to morphine

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Gabapentin
anticonvulsant drug that is used for neuropathic pain.

Procedure:
• TAP Block
a procedure done anesthetize the anterior abdominal wall

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of nausea and vomiting	How many times the patient reported nausea, and how many times they vomitted.	24 hours after surgery
Primary	Post-operative morphine consumption	Total amount of morphine the patient need to control post-operative pain	24 hours after surgery.
Secondary	VAS Scores	Visual analog scale that rates a patient's pain	24 hours after surgery