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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Kane, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01479270
First received: November 22, 2011
Last updated: October 23, 2012
Last verified: October 2012

November 22, 2011
October 23, 2012
May 2011
September 2011   (final data collection date for primary outcome measure)
QoR-40 survey on postop day #1 [ Time Frame: 48 hours postop ] [ Designated as safety issue: No ]
40 question survey completed on paper or by telephone on POD#1 or POD#2
Same as current
Complete list of historical versions of study NCT01479270 on ClinicalTrials.gov Archive Site
  • narcotic use [ Time Frame: 24 hours postop ] [ Designated as safety issue: No ]
    narcotic use in mg of Morphine will be recorded
  • VAS for pain [ Time Frame: 24 hours postop ] [ Designated as safety issue: No ]
    visual analogue scales for pain will be completed on POD#0 and POD#1
  • Anesthesia time [ Time Frame: intraop ] [ Designated as safety issue: No ]
    Time of surgery and total time under anesthesia in the OR will be recorded.
Same as current
Not Provided
Not Provided
 
Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery
Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Pain, Postoperative
  • Anesthesia
Drug: TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
Other Names:
  • Ropivacaine with Epinephrine
  • TAP Block
  • Active Comparator: TAP Block
    20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
    Intervention: Drug: TAP Block of 0.25% Ropivacaine with 1:200,000 Epinephrine
  • No Intervention: No Block
    Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.
Kane SM, Garcia-Tomas V, Alejandro-Rodriguez M, Astley B, Pollard RR. Randomized trial of transversus abdominis plane block at total laparoscopic hysterectomy: effect of regional analgesia on quality of recovery. Am J Obstet Gynecol. 2012 Nov;207(5):419.e1-5. doi: 10.1016/j.ajog.2012.06.052. Epub 2012 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
January 2012
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01479270
IRB10-01517
No
Sarah Kane, MetroHealth Medical Center
MetroHealth Medical Center
Not Provided
Principal Investigator: Sarah M Kane, MD MetroHealth Medical Center
MetroHealth Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP