Pain Perception After Tubal Ligation

Pain Clinical Trial

Official title:

Retrospective Investigation of Postoperative Pain Perception After Laparoscopic Tubal Sterilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062087
• Other study ID #: 2010002
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: May 1, 2012
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 52 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Oklahoma State University Medical Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Børdahl 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of postoperative narcotic required before dismissal from hospital		up to 12 hours	No
Secondary	The amount of time required for postoperative hospitalization before dismissal		2-12 hours	No