NCT01075074

Brief Summary

The use of pre-operative transversus abdominis plane block will reduce pain after outpatient laparoscopic gynecological surgery and improve quality of recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 3, 2012

Completed
Last Updated

November 21, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

February 23, 2010

Results QC Date

March 6, 2012

Last Update Submit

October 29, 2013

Conditions

PainSurgery

Keywords

PainTAP blockLaparoscopicGynecologic

Outcome Measures

Primary Outcomes (1)

  • The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery

    The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.

    24 hours after surgery

Secondary Outcomes (3)

  • Pain Burden During Early Recovery From Anesthesia

    Post Operative

  • Opioid Pain Medications Consumed During the First 24 Hours Post Surgery

    24 hours

  • Time to Hospital Discharge Readiness

    24 hours

Study Arms (3)

Ropivacaine 0.05%

ACTIVE COMPARATOR

Subject received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side

Procedure: Transversus abdominis plane block

Normal Saline

PLACEBO COMPARATOR

Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.

Procedure: Transversus abdominis plane block

Ropivacaine 0.25%

ACTIVE COMPARATOR

Subjects received a bilateral transversus abdominis plane block using 15cc of 0.25% ropivacaine on each side

Procedure: Transversus abdominis plane block

Interventions

Transversus abdominis plane blockPROCEDURE

A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.

Also known as: TAP block
Normal SalineRopivacaine 0.05%Ropivacaine 0.25%

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-64 years
  • Surgery: Outpatient Gynecological laparoscopic surgery
  • ASA status: I and II
  • Fluent in English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (10)

  • 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.

    PMID: 17714620BACKGROUND

  • 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.

    PMID: 10718794BACKGROUND

  • 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.

    PMID: 10910857BACKGROUND

  • 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.

    PMID: 11703235BACKGROUND

  • 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.

    PMID: 9861124BACKGROUND

  • 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.

    PMID: 12670813BACKGROUND

  • Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.

    PMID: 19606021BACKGROUND

  • Turner GA, Chalkiadis G. Comparison of preoperative with postoperative lignocaine infiltration on postoperative analgesic requirements. Br J Anaesth. 1994 May;72(5):541-3. doi: 10.1093/bja/72.5.541.

    PMID: 8198905BACKGROUND

  • O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.

    PMID: 16418039BACKGROUND

  • Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

    PMID: 18020088BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

We did not obtain local anesthetic levels to compare safety profile. We were underpowered to detect a difference in the physical comfort dimension of the QOR questionnaire between the ropivacaine groups and the saline group.

Results Point of Contact

Title
Gildasio De Oliveira, MD
Organization
Northwestern University
g-jr@northwestern.edu
312-926-8373

Study Officials

  • Gildasio DeOliveira, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

November 21, 2013

Results First Posted

April 3, 2012

Record last verified: 2013-10

Locations

US(1)