PainNCT01062087
Pain Perception After Tubal Ligation
An observational study of Pain, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine, Lidocaine
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Urban clinic population, mix of ethnicities, most are Medicaid patients
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University Medical Center
Tulsa, Oklahoma, 74127
About this study
Official title: Retrospective Investigation of Postoperative Pain Perception After Laparoscopic Tubal Sterilization
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.
- Conditions
- Pain
- Being tested
- Bupivacaine, Lidocaine
- Keywords
- postoperative pain, tubal ligation, local anesthetic
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine, LidocaineDrug
Also called Marcaine
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
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetic | Women who received local anesthetic during surgery in addition to general anesthesia Receives: Drug: Bupivacaine, Lidocaine | |
| No local anesthetic | Women who did not receive any local anesthetic during surgery, but did have general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of postoperative narcotic required before dismissal from hospital
Measured: up to 12 hours
Secondary outcomes (1)
The amount of time required for postoperative hospitalization before dismissal
Measured: 2-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah McCoy, Oklahoma State University Center for Health Sciences
- Investigators
- Terry Badzinski, DO, Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062087
- Sponsor's protocol ID
- 2010002
- Status last verified
- May 2012
- First submitted
- 2 Feb 2010
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8416449Benhamou D, Narchi P, Mazoit JX, Fernandez H. Postoperative pain after local anesthetics for laparoscopic sterilization. Obstet Gynecol. 1994 Nov;84(5):877-80.
PubMed 7936530
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Investigation of Postoperative Pain Perception After Laparoscopic Tubal Sterilization
- ClinicalTrials.gov ID
- NCT01062087
- Acronym / sponsor ID
- 2010002
- Conditions
- Pain
- Keywords
- postoperative pain, tubal ligation, local anesthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthetic | – | Drug: Bupivacaine, LidocaineWomen who received local anesthetic during surgery in addition to general anesthesia |
| No local anesthetic | – | –Women who did not receive any local anesthetic during surgery, but did have general anesthesia |
Who may qualify
- Ages
- 21 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Urban clinic population, mix of ethnicities, most are Medicaid patients
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine, LidocaineAlso: MarcaineInjection 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 | Drug | Local anesthetic |
Primary outcome
Amount of postoperative narcotic required before dismissal from hospital
Time frame: up to 12 hours
1 secondary outcome
The amount of time required for postoperative hospitalization before dismissal
Time frame: 2-12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Background: PubMed 8416449Bordahl 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.
- Background: PubMed 7936530Benhamou D, Narchi P, Mazoit JX, Fernandez H. Postoperative pain after local anesthetics for laparoscopic sterilization. Obstet Gynecol. 1994 Nov;84(5):877-80.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Badzinski, DO principal investigator
Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of postoperative narcotic required before dismissal from hospital (time frame: up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01062087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.