Post Operative PainNCT01442818
Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
A study testing Dilaudid PCA and Dilaudid IV Scheduled in people with Post Operative Pain, run by TriHealth Inc. at 1 site in United States.
Trial summary
The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Dilaudid PCA and Dilaudid IV Scheduled
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2012
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients will be limited to those from the Division of Urogynecology to ensure similar surgical techniques. They will be between the ages of 18 and 70 and undergoing major vaginal reconstruction.
- All patients must undergo vaginal reconstructive surgery including: anterior repair, posterior repair, and intraperitoneal vaginal vault suspension. The addition of vaginal hysterectomy, enterocele repair, or suburethral sling is not cause for exclusion.
Who cannot join
- Any patient who has an allergy to hydromorphone/Dilaudid.
- Any patient already taking chronic opioids, defined as daily use.
- All patients with renal insufficiency or failure.
- All patients with liver failure.
- Any patient who is not having general anesthesia.
- Any patient undergoing abdominal or laparoscopic procedures: sacral colpopexy, laparoscopic hysterectomy or oophorectomy, Burch procedure, or any procedure that enters the abdominal fascia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia
The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.
Read the detailed description
The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.
In order to determine if there is a significant correlation, secondary outcomes will include the daily and total narcotic volume used, common side effects from the opioid including nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel movement, all complications, and procedure performed.
- Conditions
- Post Operative Pain
- Being tested
- Dilaudid PCA, Dilaudid IV Scheduled
- Keywords
- vaginal reconstructive surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilaudid PCADrug
Also called hydromorphone
PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.
Dilaudid IV ScheduledDrug
Also called hydromorphone
Nurse administered IV Dilaudid 0.5mg every 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled IV post op | Experimental | Patient's will receive scheduled nurse administered IV pain medications post operatively. Receives: Drug: Dilaudid IV Scheduled |
| PCA post op | Experimental | Patients will receive PCA for pain control post operatively. Receives: Drug: Dilaudid PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Control
Patient's reported pain on a VAS on all postoperative day one.
Measured: post operative day 1
Secondary outcomes (3)
Patient Satisfaction with Pain Control
Patient's satisfaction with pain control on a VAS on all postoperative day one.
Measured: post operative day 1
patient perceived pain at 2 weeks
VAS for pain will be filled out at the patient's two week post op office visit.
Measured: 2 weeks post op
patient dissatisfaction with pain control at 2 weeks
patient will fill out a VAS for satisfaction with pain control at their two week post operative visit.
Measured: 2 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catrina C Crisp, MD, Principal investigator, TriHealth Division of Urogynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442818
- Sponsor's protocol ID
- 10072
- Status last verified
- Jul 2015
- First submitted
- 8 Sep 2010
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia
- ClinicalTrials.gov ID
- NCT01442818
- Acronym / sponsor ID
- 10072
- Conditions
- Post Operative Pain
- Keywords
- vaginal reconstructive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Sep 2011 (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 investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.
Detailed description
The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.
In order to determine if there is a significant correlation, secondary outcomes will include the daily and total narcotic volume used, common side effects from the opioid including nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel movement, all complications, and procedure performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled IV post op | Experimental | Drug: Dilaudid IV ScheduledPatient's will receive scheduled nurse administered IV pain medications post operatively. |
| PCA post op | Experimental | Drug: Dilaudid PCAPatients will receive PCA for pain control post operatively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients will be limited to those from the Division of Urogynecology to ensure similar surgical techniques. They will be between the ages of 18 and 70 and undergoing major vaginal reconstruction.
- All patients must undergo vaginal reconstructive surgery including: anterior repair, posterior repair, and intraperitoneal vaginal vault suspension. The addition of vaginal hysterectomy, enterocele repair, or suburethral sling is not cause for exclusion.
Key exclusion criteria (6 listed)
- Any patient who has an allergy to hydromorphone/Dilaudid.
- Any patient already taking chronic opioids, defined as daily use.
- All patients with renal insufficiency or failure.
- All patients with liver failure.
- Any patient who is not having general anesthesia.
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 |
|---|---|---|
| Dilaudid PCAAlso: hydromorphonePCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit. | Drug | PCA post op |
| Dilaudid IV ScheduledAlso: hydromorphoneNurse administered IV Dilaudid 0.5mg every 2 hours. | Drug | Scheduled IV post op |
Primary outcome
Patient Pain Control
Time frame: post operative day 1
Patient's reported pain on a VAS on all postoperative day one.
3 secondary outcomes
Patient Satisfaction with Pain Control
Time frame: post operative day 1
patient perceived pain at 2 weeks
Time frame: 2 weeks post op
patient dissatisfaction with pain control at 2 weeks
Time frame: 2 weeks post op
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 10 Jul 2015.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Catrina C Crisp, MD principal investigator
TriHealth Division of Urogynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dilaudid PCA and Dilaudid IV Scheduled in people with Post Operative Pain, run by TriHealth Inc. 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 2 inclusion and 6 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 10 Jul 2015. 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?
Patient Pain Control (time frame: post operative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2015.