Shoulder PainNCT00575237
A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain
A study testing Recruitment manouver in people with Shoulder Pain, run by Phelps, Paul, M.D. at 1 site in United States.
Trial summary
A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as nausea and vomiting after laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women only
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Recruitment manouver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Feb 2005
- 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 15 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- female
- age 15-65
- ASA I-II
- scheduled for outpatient gynaecological procedure
Who cannot join
- previous laparatomy
- patients requiring hospitalisation
- procedure required conversion to laparatomy
- 48h follow-up no feasible
Trial locations and contacts
1 site in 1 country.
United States1 site
Inland Valley and Rancho Springs Medical Centers
Wildomar, California, 92595
About this study
Official title: A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial
A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as nausea and vomiting after laparoscopic surgery.
Read the detailed description
With IRB approval and informed consent, 100 female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery were randomly allocated to either the current standard (control group) or to additional efforts to remove residual CO2 at the end of surgery (intervention group; power analysis yielded 45 patients necessary per group). In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers. Postoperative shoulder pain was assessed prior to discharge and 12, 24, 36 and 48 hours later using a visual analog scale (VAS). In addition, positional characteristics of the shoulder pain and incidence of postdischarge nausea and vomiting (PDNV) were recorded 48 hours after surgery.
- Conditions
- Shoulder Pain
- Being tested
- Recruitment manouver
- Keywords
- Laparoscopic Surgery, Shoulder pain, PDNV, Anesthesia, Residual CO2, Postoperative Pain, Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery
- Medical subject headings
- Shoulder Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment manouverProcedure or surgery
In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. |
| Intervention | Experimental | Not described Receives: Procedure: Recruitment manouver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of shoulder pain
Measured: 48 hours after discharge
Secondary outcomes (1)
Incidence of Nausea and Vomiting
Measured: 24hrs after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startFeb 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phelps, Paul, M.D.
- Collaborators
- University of California, San Francisco
- Investigators
- Paul Phelps, MD, Principal investigator, Department of Anesthesia, Southwest Healthcare System, Murrieta, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575237
- Sponsor's protocol ID
- SP230819
- Status last verified
- Dec 2007
- First submitted
- 14 Dec 2007
- Last updated
- 18 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Phelps 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 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00575237
- Acronym / sponsor ID
- SP230819
- Conditions
- Shoulder Pain
- Keywords
- Laparoscopic Surgery, Shoulder pain, PDNV, Anesthesia, Residual CO2, Postoperative Pain, Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Phelps, Paul, M.D.
- Collaborators
- University of California, San Francisco
- Study start
- Feb 2004
- Study completion
- Feb 2005 (actual)
- First posted
- 18 Dec 2007 (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.
A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as nausea and vomiting after laparoscopic surgery.
Detailed description
With IRB approval and informed consent, 100 female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery were randomly allocated to either the current standard (control group) or to additional efforts to remove residual CO2 at the end of surgery (intervention group; power analysis yielded 45 patients necessary per group). In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers. Postoperative shoulder pain was assessed prior to discharge and 12, 24, 36 and 48 hours later using a visual analog scale (VAS). In addition, positional characteristics of the shoulder pain and incidence of postdischarge nausea and vomiting (PDNV) were recorded 48 hours after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. |
| Intervention | Experimental | Procedure: Recruitment manouver |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- female
- age 15-65
- ASA I-II
- scheduled for outpatient gynaecological procedure
Key exclusion criteria (4 listed)
- previous laparatomy
- patients requiring hospitalisation
- procedure required conversion to laparatomy
- 48h follow-up no feasible
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 |
|---|---|---|
| Recruitment manouverIn the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers. | Procedure or surgery | Intervention |
Primary outcome
Intensity of shoulder pain
Time frame: 48 hours after discharge
1 secondary outcome
Incidence of Nausea and Vomiting
Time frame: 24hrs after discharge
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 18 Dec 2007.
- Derived from this study: 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.
Paul Phelps, MD principal investigator
Department of Anesthesia, Southwest Healthcare System, Murrieta, California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment manouver in people with Shoulder Pain, run by Phelps, Paul, M.D. 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 4 inclusion and 4 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 18 Dec 2007. 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?
Intensity of shoulder pain (time frame: 48 hours after discharge). 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 NCT00575237, which also lists 1 linked publication.
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 18 Dec 2007.