Shoulder PainNCT02004470
Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain
A study testing Active lavage and suction in people with Shoulder Pain, run by University of Tennessee at 4 sites in United States.
Trial summary
The use of laparoscopy in gynecologic surgery has been well established to decrease morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional open abdominal surgery. However, the laparoscopic technique is associated with post-operative shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Active lavage and suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2014to Jun 2014
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking patient
- Female
- Age 18-75
- must undergo laparoscopic surgery
- willing to participate in the study
Who cannot join
- Male patients
- Under 18 or older than 75
- Laparoscopic procedures that get converted to laparotomy
- Intraoperative hemorrhage more than 500 cc
- Patients with active joint disease
- History of shoulder surgery
Show all 12Show fewer
- Intraoperative laceration to the liver
- Malignancy
- Long term daily narcotic use
- Chronic right upper quadrant/ shoulder pain
- Pregnancy
- History of dementia, Alzheimers, stroke or other condition causing altered mental status
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Memorial Hospital
Chattanooga, Tennessee, 37404
Parkridge East Hospital
Chattanooga, Tennessee, 37412
Erlanger East Hospital
Chattanooga, Tennessee, 37421
About this study
Official title: Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial
The use of laparoscopy in gynecologic surgery has been well established to decrease morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional open abdominal surgery. However, the laparoscopic technique is associated with post-operative shoulder pain.
We hypothesize that a combination of intraperitoneal saline lavage and active suction removal of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.
- Conditions
- Shoulder Pain
- Being tested
- Active lavage and suction
- Keywords
- post laparoscopic shoulder pain, active suction, lavage and suction, right shoulder pain, post operative shoulder pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active lavage and suctionProcedure or surgery
Active lavage and suction of the right upper quadrant will be performed as the laparoscopic procedure is about to be terminated.
| Study group | Role | What they receive |
|---|---|---|
| Passive exsufflation | No intervention | Will not actively suction carbon dioxide from abdomen. Open laparoscopic trocars and allow C02 to passively empty from abdomen. |
| Active lavage and suction | Experimental | This step is already employed in many ongoing surgeries where normal saline will be used to lavage the right upper quadrant and then will be suctioned out to remove as much Carbon dioxide from the patient's abdomen and to therefore decrease postoperative pain. Receives: Procedure: Active lavage and suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.
Measured: 12 hours
Pain Score
We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10
Measured: 24 hours
Pain Score
We will assess a pain score based on a visual analog score of 1-10 at 48 hours post operatively.
Measured: 48 hours
Secondary outcomes (4)
operative time
We will assess how long each surgery takes to complete.
Measured: 24 hours
blood loss
We will assess intraoperative blood loss.
Measured: 6 hours
analgesic use
We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.
Measured: 7 days
Anti emetic use
Total amount of intravenous and oral narcotic used postoperatively.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Hadiashar, MD, Principal investigator, University of Tennessee Chattanooga College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004470
- Sponsor's protocol ID
- LAS-37405
- Status last verified
- Jan 2014
- First submitted
- 15 Nov 2013
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
PubMed 22184293Tsai HW, Wang PH, Yen MS, Chao KC, Hsu TF, Chen YJ. Prevention of postlaparoscopic shoulder and upper abdominal pain: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):526-531. doi: 10.1097/AOG.0b013e318283fcca.
PubMed 23635614Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
PubMed 18448749
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02004470
- Acronym / sponsor ID
- LAS-37405
- Conditions
- Shoulder Pain
- Keywords
- post laparoscopic shoulder pain, active suction, lavage and suction, right shoulder pain, post operative shoulder pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 9 Dec 2013 (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 use of laparoscopy in gynecologic surgery has been well established to decrease morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional open abdominal surgery. However, the laparoscopic technique is associated with post-operative shoulder pain.
We hypothesize that a combination of intraperitoneal saline lavage and active suction removal of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive exsufflation | No intervention | –Will not actively suction carbon dioxide from abdomen. Open laparoscopic trocars and allow C02 to passively empty from abdomen. |
| Active lavage and suction | Experimental | Procedure: Active lavage and suctionThis step is already employed in many ongoing surgeries where normal saline will be used to lavage the right upper quadrant and then will be suctioned out to remove as much Carbon dioxide from the patient's abdomen and to therefore decrease postoperative pain. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking patient
- Female
- Age 18-75
- must undergo laparoscopic surgery
- willing to participate in the study
Key exclusion criteria (12 listed)
- Male patients
- Under 18 or older than 75
- Laparoscopic procedures that get converted to laparotomy
- Intraoperative hemorrhage more than 500 cc
- Patients with active joint disease
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 |
|---|---|---|
| Active lavage and suctionActive lavage and suction of the right upper quadrant will be performed as the laparoscopic procedure is about to be terminated. | Procedure or surgery | Active lavage and suction |
Primary outcome
Pain Score
Time frame: 12 hours
We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.
Pain Score
Time frame: 24 hours
We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10
Pain Score
Time frame: 48 hours
We will assess a pain score based on a visual analog score of 1-10 at 48 hours post operatively.
4 secondary outcomes
operative time
Time frame: 24 hours
blood loss
Time frame: 6 hours
analgesic use
Time frame: 7 days
Anti emetic use
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Background: PubMed 22184293Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
- Results publication: PubMed 23635614Tsai HW, Wang PH, Yen MS, Chao KC, Hsu TF, Chen YJ. Prevention of postlaparoscopic shoulder and upper abdominal pain: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):526-531. doi: 10.1097/AOG.0b013e318283fcca.
- Results publication: PubMed 18448749Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
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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.
Maryam Hadiashar, MD principal investigator
University of Tennessee Chattanooga College of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active lavage and suction in people with Shoulder Pain, run by University of Tennessee at 4 sites 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam Hadiashar, MD (4086051927, maryamhad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 12 hours). The study lists 3 primary outcomes in all. 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 NCT02004470, which also lists 3 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 6 Jan 2014.