Shoulder PainPhase 3NCT01433874
Decreasing Upper and Shoulder Pain After Laparoscopic Surgery
A Phase 3 study testing Pulmonary recruitment maneuver, Intraperitoneal normal saline infusion and combined group in people with Shoulder Pain and Nausea, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Shoulder Pain, Nausea
- What is being tested?
- Pulmonary recruitment maneuver, Intraperitoneal normal saline infusion and combined group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Dec 2012
- Phase
- Phase 3
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receive benign gynecological laparoscopic surgery
- American Society of Anesthesiologists(ASA) physical status of patient classification I-II.
Who cannot join
- The procedure will be required to conversion to laparotomy
- Any cardio-vascular diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Yi-Jen Chen, M.D.,Ph D., 886-2-2875-7566, chenyj@vghtpe.gov.tw
Hsiao-Wen Tsai, M.D.
About this study
Official title: Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery
Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.
The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.
This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.
Read the detailed description
This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative upper abdominal and shoulder pain after laparoscopic surgery.
- Conditions
- Shoulder Pain, Nausea
- Being tested
- Pulmonary recruitment maneuver, Intraperitoneal normal saline infusion, combined group, Control group
- Keywords
- Shoulder pain, Upper abdominal pain, Laparoscopic surgery, Abdominal fullness
- Medical subject headings
- Shoulder Pain, Nausea, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary recruitment maneuverProcedure or surgery
A pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.
Intraperitoneal normal saline infusionProcedure or surgery
The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. We will leave the fluid in the abdominal cavity
combined groupProcedure or surgery
The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure oof 60 cmH2O.
Control groupProcedure or surgery
Co2 was removed by passive exsufflation through the port site.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary recruitment maneuver | Experimental | A pulmonary recruitment maneuver consisting five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds. Receives: Procedure: Pulmonary recruitment maneuver |
| Intraperitoneal normal saline infusion | Experimental | The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc we will leave the fluid in the abdominal cavity. Receives: Procedure: Intraperitoneal normal saline infusion |
| combined group | Experimental | The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH20. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds. Receives: Procedure: combined group |
| Control group | Placebo comparator | Co2 was removed by passive exsufflation through the port site Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery
The investigators will follow the patient in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder and upper abdominal pain after laparoscopic surgery.
Measured: The first 48 hours after the surgery
Secondary outcomes (1)
nausea or abdominal fullness after laparoscopic surgery
postoperative illness, such as nausea, vomiting, or abdominal fullness were also recorded.
Measured: The first 38 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Investigators
- Hsiao-Wen Tsai, M.D., Principal investigator, Taipei Veterans General Hospital, TaiwanYi-Jen Chen, M.D., Ph D., Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433874
- Sponsor's protocol ID
- 100-03-001
- Status last verified
- Jul 2011
- First submitted
- 14 Jun 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 18448749Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
PubMed 17043939Tsai 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 23635614
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01433874
- Acronym / sponsor ID
- 100-03-001
- Conditions
- Shoulder Pain, Nausea
- Keywords
- Shoulder pain, Upper abdominal pain, Laparoscopic surgery, Abdominal fullness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 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.
Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.
The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.
This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.
Detailed description
This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative upper abdominal and shoulder pain after laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulmonary recruitment maneuver | Experimental | Procedure: Pulmonary recruitment maneuverA pulmonary recruitment maneuver consisting five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds. |
| Intraperitoneal normal saline infusion | Experimental | Procedure: Intraperitoneal normal saline infusionThe upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc we will leave the fluid in the abdominal cavity. |
| combined group | Experimental | Procedure: combined groupThe upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH20. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds. |
| Control group | Placebo comparator | Procedure: Control groupCo2 was removed by passive exsufflation through the port site |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receive benign gynecological laparoscopic surgery
- American Society of Anesthesiologists(ASA) physical status of patient classification I-II.
Key exclusion criteria (2 listed)
- The procedure will be required to conversion to laparotomy
- Any cardio-vascular diseases
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 |
|---|---|---|
| Pulmonary recruitment maneuverA pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds. | Procedure or surgery | Pulmonary recruitment maneuver |
| Intraperitoneal normal saline infusionThe upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. We will leave the fluid in the abdominal cavity | Procedure or surgery | Intraperitoneal normal saline infusion |
| combined groupThe upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure oof 60 cmH2O. | Procedure or surgery | combined group |
| Control groupCo2 was removed by passive exsufflation through the port site. | Procedure or surgery | Control group |
Primary outcome
The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery
Time frame: The first 48 hours after the surgery
The investigators will follow the patient in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder and upper abdominal pain after laparoscopic surgery.
1 secondary outcome
nausea or abdominal fullness after laparoscopic surgery
Time frame: The first 38 hours after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
- 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.
- Results publication: PubMed 17043939Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
- Derived from this study: 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.
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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.
Hsiao-Wen Tsai, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
Yi-Jen Chen, M.D., Ph D. study chair
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pulmonary recruitment maneuver, Intraperitoneal normal saline infusion and combined group in people with Shoulder Pain and Nausea, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 2 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 14 Sep 2011. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yi-Jen Chen, M.D., Ph D. (886-2-2875-7566, chenyj@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery (time frame: The first 48 hours after the surgery). 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 NCT01433874, 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 14 Sep 2011.