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Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy (TAP HYS)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Drug .5% Ropivacaine
20 cc of 0.25% ropivacaine
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Pain, Post Operative, Opioids, Laparoscopic, Surgery, Hysterectomy

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18-64 years
  • Surgery: Laparoscopic Hysterectomy surgery
  • ASA status: I and II
  • Fluent in English

Exclusion Criteria:

  • History of allergy to local anesthetics
  • History of chronic opioid use
  • Pregnant patients
  • BMI greater than 30

Drop-out criteria:

  • Patient or surgeon request
  • Complications related to the procedure

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Drug .5% Ropivacaine

20 cc of 0.25% ropivacaine

Arm Description

sterile normal saline as placebo

Instillation of 20 cc of 0.5% ropivacaine

Instillation of 20 cc of 0.25% ropivacaine

Outcomes

Primary Outcome Measures

QoR40 on the Day After Surgery
QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.

Secondary Outcome Measures

24 Total Morphine Consumption
Total 24 total morphine consumption post operative.

Full Information

First Posted
February 22, 2010
Last Updated
April 9, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01074229
Brief Title
Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy
Acronym
TAP HYS
Official Title
The Effect of Pre-operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Laparoscopic Hysterectomy: a Prospective, Randomized, Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery. Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics. Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%. This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pain, Post Operative, Opioids, Laparoscopic, Surgery, Hysterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sterile normal saline as placebo
Arm Title
Drug .5% Ropivacaine
Arm Type
Active Comparator
Arm Description
Instillation of 20 cc of 0.5% ropivacaine
Arm Title
20 cc of 0.25% ropivacaine
Arm Type
Active Comparator
Arm Description
Instillation of 20 cc of 0.25% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sterile normal saline
Intervention Description
placebo injection
Intervention Type
Drug
Intervention Name(s)
Drug .5% Ropivacaine
Other Intervention Name(s)
.5% Ropivacaine
Intervention Description
.5% ropivacaine 20 mls on each side of abdomen
Intervention Type
Drug
Intervention Name(s)
20 cc of 0.25% ropivacaine
Other Intervention Name(s)
.25% ropivacaine
Intervention Description
Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine
Primary Outcome Measure Information:
Title
QoR40 on the Day After Surgery
Description
QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
24 Total Morphine Consumption
Description
Total 24 total morphine consumption post operative.
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-64 years Surgery: Laparoscopic Hysterectomy surgery ASA status: I and II Fluent in English Exclusion Criteria: History of allergy to local anesthetics History of chronic opioid use Pregnant patients BMI greater than 30 Drop-out criteria: Patient or surgeon request Complications related to the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gildasio DeOliveira, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16738152
Citation
Jacobson GF, Shaber RE, Armstrong MA, Hung YY. Hysterectomy rates for benign indications. Obstet Gynecol. 2006 Jun;107(6):1278-83. doi: 10.1097/01.AOG.0000210640.86628.ff.
Results Reference
background
PubMed Identifier
17346525
Citation
Babalola EO, Bharucha AE, Schleck CD, Gebhart JB, Zinsmeister AR, Melton LJ 3rd. Decreasing utilization of hysterectomy: a population-based study in Olmsted County, Minnesota, 1965-2002. Am J Obstet Gynecol. 2007 Mar;196(3):214.e1-7. doi: 10.1016/j.ajog.2006.10.390.
Results Reference
background
PubMed Identifier
19762758
Citation
Lenz H, Sandvik L, Qvigstad E, Bjerkelund CE, Raeder J. A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. Anesth Analg. 2009 Oct;109(4):1279-83. doi: 10.1213/ane.0b013e3181b0f0bb.
Results Reference
background
PubMed Identifier
17022920
Citation
Thiel JA, Kamencic H. Assessment of costs associated with outpatient total laparoscopic hysterectom. J Obstet Gynaecol Can. 2006 Sep;28(9):794-798. doi: 10.1016/S1701-2163(16)32258-7.
Results Reference
background
PubMed Identifier
17714620
Citation
Lovatsis D, Jose JB, Tufman A, Drutz HP, Murphy K. Assessment of patient satisfaction with postoperative pain management after ambulatory gynaecologic laparoscopy. J Obstet Gynaecol Can. 2007 Aug;29(8):664-7. doi: 10.1016/s1701-2163(16)32552-x.
Results Reference
background
PubMed Identifier
10718794
Citation
Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.
Results Reference
background
PubMed Identifier
10910857
Citation
Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.
Results Reference
background
PubMed Identifier
11703235
Citation
Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.
Results Reference
background
PubMed Identifier
9861124
Citation
Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.
Results Reference
background
PubMed Identifier
12670813
Citation
Keita H, Benifla JL, Le Bouar V, Porcher R, Wachowska B, Bedairia K, Mantz J, Desmonts JM. Prophylactic ip injection of bupivacaine and/or morphine does not improve postoperative analgesia after laparoscopic gynecologic surgery. Can J Anaesth. 2003 Apr;50(4):362-7. doi: 10.1007/BF03021033.
Results Reference
background
PubMed Identifier
22105251
Citation
De Oliveira GS Jr, Milad MP, Fitzgerald P, Rahmani R, McCarthy RJ. Transversus abdominis plane infiltration and quality of recovery after laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1230-1237. doi: 10.1097/AOG.0b013e318236f67f.
Results Reference
derived

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Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy

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