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OpenTrials
Completed

NCT Number: NCT01479270

Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect 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.

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Key information

Conditions

Pain, Postoperative Anesthesia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP Block

Drug

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

Primary outcomes

  1. Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2

    Time frame: Postop Day #1 or Day #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).

Secondary outcomes

  1. Narcotic Use

    Time frame: Postop Day #0 and Day #1

    narcotic use in mg of Morphine will be recorded

  2. Visual Analog Scale (VAS) for Pain

    Time frame: 2 and 24 hours post operative

    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.)

  3. Intraoperative Time

    Time frame: the total intraoperative time in minutes

    The total time in the operating room will be recorded to see if there is a difference between groups.

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

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

Acronym: TAP

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 24, 2011
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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