Pain Perception After Tubal Ligation

NCT ID: NCT01062087

Last Updated: 2012-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Local anesthetic

Women who received local anesthetic during surgery in addition to general anesthesia

Bupivacaine, Lidocaine

Intervention Type DRUG

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

No local anesthetic

Women who did not receive any local anesthetic during surgery, but did have general anesthesia

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sarah McCoy

OB/GYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry Badzinski, DO

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Health Sciences

Locations

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Oklahoma State University Medical Center

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

References

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Bordahl PE, Raeder JC, Nordentoft J, Kirste U, Refsdal A. Laparoscopic sterilization under local or general anesthesia? A randomized study. Obstet Gynecol. 1993 Jan;81(1):137-41.

Reference Type BACKGROUND
PMID: 8416449 (View on PubMed)

Benhamou D, Narchi P, Mazoit JX, Fernandez H. Postoperative pain after local anesthetics for laparoscopic sterilization. Obstet Gynecol. 1994 Nov;84(5):877-80.

Reference Type BACKGROUND
PMID: 7936530 (View on PubMed)

Other Identifiers

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2010002

Identifier Type: -

Identifier Source: org_study_id

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