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Pain Perception After Tubal Ligation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062087
First Posted: February 4, 2010
Last Update Posted: May 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sarah McCoy, Oklahoma State University Center for Health Sciences
  Purpose
The purpose of this study is to attempt to determine retrospectively whether there was a statistically significant difference in patient need for postoperative narcotics between two different groups of women who received a laparoscopic tubal ligation. One group received a local anesthetic injection or gel at the surgical sites, in addition to general anesthesia. The other group did not receive any local anesthetic but did receive general anesthesia. The investigators hypothesize that the group that received the local anesthetic injection or gel had lower average postoperative narcotic requirements and shorter postoperative dismissal to home times than the group that did not receive the auxiliary local anesthetic.

Condition Intervention
Pain Drug: Bupivacaine, Lidocaine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Investigation of Postoperative Pain Perception After Laparoscopic Tubal Sterilization

Resource links provided by NLM:


Further study details as provided by Sarah McCoy, Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • Amount of postoperative narcotic required before dismissal from hospital [ Time Frame: up to 12 hours ]

Secondary Outcome Measures:
  • The amount of time required for postoperative hospitalization before dismissal [ Time Frame: 2-12 hours ]

Enrollment: 62
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Local anesthetic
Women who received local anesthetic during surgery in addition to general anesthesia
Drug: Bupivacaine, Lidocaine
Injection at surgical port site of 0.25% Bupivicaine, 2.5 mg/mL NaCl solution and/or application of Lidocaine HCl jelly 2% aqueous, up to 5 mL
Other Name: Marcaine
No local anesthetic
Women who did not receive any local anesthetic during surgery, but did have general anesthesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Urban clinic population, mix of ethnicities, most are Medicaid patients
Criteria

Inclusion Criteria:

  • Female, age 21-52,having a laparoscopic tubal ligation by the fallopia ring method at Oklahoma State University Medical Center between January 1, 2005 and December 31, 2009

Exclusion Criteria:

  • We will exclude women with the following comorbid conditions, since they may alter the patient's pain level or her perception of pain after the tubal ligation: history of chronic pelvic pain, history of pelvic inflammatory disease, opiate abuse, conversion to open procedure, unsuccessful tubal ligation, laceration of tube, more than one ring placed on single tube, admittance to the hospital, additional procedures performed, endometriosis, allergy to marcaine, lidocaine, or bupivicaine.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062087


Locations
United States, Oklahoma
Oklahoma State University Medical Center
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Terry Badzinski, DO Oklahoma State University Center for Health Sciences
  More Information

Publications:
Responsible Party: Sarah McCoy, OB/GYN, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT01062087     History of Changes
Other Study ID Numbers: 2010002
First Submitted: February 2, 2010
First Posted: February 4, 2010
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Sarah McCoy, Oklahoma State University Center for Health Sciences:
postoperative pain
tubal ligation
local anesthetic

Additional relevant MeSH terms:
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action