Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery

Anesthesia Clinical Trial

— TAP  

Official title:

Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479270
• Other study ID #: IRB10-01517
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2018
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Any patient undergoing laparoscopic hysterectomy

• Age ranges 18-80

• Reading literacy

• English speaking

• Able to give informed consent

Exclusion Criteria:

• History of relevant drug allergy

• Chronic opioid users who may have tolerance to pain medications

• Inability to understand written consent forms or give consent

• Age less than 18 or over 80

• Any conversion to open surgery

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative

Intervention

Drug:
• TAP Block
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2	40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).	Postop Day #1 or Day #2
Secondary	Narcotic Use	narcotic use in mg of Morphine will be recorded	Postop Day #0 and Day #1
Secondary	Visual Analog Scale (VAS) for Pain	visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)	2 and 24 hours post operative
Secondary	Intraoperative Time	The total time in the operating room will be recorded to see if there is a difference between groups.	the total intraoperative time in minutes