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Completed

NCT Number: NCT01204892

Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ben Taub General Hospital

Houston, Texas, 77030, United States

About this study

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient ages 18-64
  • American Society of Anesthesiology Physical Status I, II or III
  • Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion criteria

  • Open cholecystectomy - excluded due to increased levels of pain in open procedures
  • Scheduled for ambulatory surgery
  • Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
  • Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
  • Allergy or contraindication to any of the study medications or anesthetic agents
  • Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
  • Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
  • Pregnancy
  • Prisoners
  • Patient or surgeon refusal

Treatment and study plan

TAP Block

Procedure

Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia

local infiltration

Procedure

20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports

Primary outcomes

  1. Pain

    Time frame: 24 hours

    Pain scores on NAS scale (0-10) at the following times:

    Preop, Time 0, Time 1, Time 2, Time 4, Time 8, Time 12, Time 24

Secondary outcomes

  1. PONV (Postoperative nausea and vomiting)

    Time frame: 24 hours

    PONV events in first 24 hours

  2. Narcotics use

    Time frame: 24 hours

    Fentanyl, morphine, and hydrocodone/apap total for 24 hours

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Postoperative Pain After Laparoscopic Cholecystectomy in Patients Receiving Bilateral Ultrasound-guided Transverse Abdominis Plane Block Compared With Local Anesthetic Infiltration of Trochar Insertion Sites With Ropivacaine 0.5%

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 17, 2010
Registry last updated
Jul 12, 2012

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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