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Laparoscopic SurgeryNCT04386603

Risk Factors for Postoperative Shoulder-tip Pain After Laparoscopic Surgery Undergoing General Anesthesia

An observational study of Laparoscopic Surgery and Anesthesia, run by Shenzhen Second People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To find out the risk factors for postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Laparoscopic Surgery, Anesthesia
How many people
1,311 participants
Where
1 siteChina
Study dates
1 Jun 2019to 31 Dec 2019
How long will I take part?
2 Days
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The patients included in this research all have diseases which need to have surgeries to fix their problems.Some of them not only have one disease but have two or more diseases such as cardiovascular disfunction,respiratory disfunction and so on.All of them are Asian and over 18 years old.

Who may be able to join

  • Patients over 18 years old (including 18 years old) having gynecologic or gastrointestinal or hepatobiliary surgery undergoing general anesthesia;
  • Patients agreeing to participate in the study and sign the informed consent.

Who cannot join

  • Patients under 18 years age or having emergency laparoscopic surgery;
  • Patients having laparoscopy but not undergoing general anesthesia;
  • Patients undergoing laparoscopy and having hysteroscopy at the same time.
  • Patients undergoing laparoscopy and having fistulostomy at the same time.
  • Patients having regional thermoperfusion after laparoscopic surgery.
  • Laparoscopy being needed to converse to laparotomy.
Show all 13Show fewer
  • Patients having shoulder pain or history of periarthritis of shoulder or long-term taking painkillers.
  • Patients having severe psychological problem and unable to cooperate with our study.
  • Patients being sent to ICU for further treatment after operation.
  • Patients being discharged within 2 days after operation and losing contact.
  • Patients having another operation after laparoscopy.
  • Patients taking another painkillers except using patient-controlled intravenous analgesia.
  • Patients refusing to take part in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518035

Other trials in China

About this study

To find out the risk factors for postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia.

Read the detailed description

To find out the risk factors for postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia.Besides,this research also aims to observe the incidence of postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia.

Keywords
risk factor, laparoscopic surgery, postoperative shoulder pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04386603
Study groupRoleWhat they receive
shoulder-tip pain groupThe patients in this group have postoperative phoulder-tip pain after laparoscopic surgery undergoing general anesthesia.
non-shoulder-tip pain groupThe patients in this group don't have postoperative phoulder-tip pain after laparoscopic surgery undergoing general anesthesia.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. inpatient department

    Compare the inpatient department difference between two groups.The inpatient department include the department of gynecology, gastrointestinal surgery and hepatolugical surgery.The investigators read the medical record to find out which department the patient is in.

    Measured: Baseline (before laparoscopic surgery)

  2. sex

    Compare sex(male or female)difference between two groups.

    Measured: Baseline (before laparoscopic surgery)

  3. age

    Compare age difference between two groups.

    Measured: Baseline (before laparoscopic surgery)

  4. body mass index(BMI)

    Compare BMI difference between two groups.First,investigators get the weight(kg）and height(m) of the patient from medical record.Then BMI(kg/m^2) is calculated with the formula,weight(kg)/height(m)^2.

    Measured: Baseline (before laparoscopic surgery)

  5. ASA grade

    Compare ASA grade difference between two groups.The ASA grade includes five grades(Ⅰ,Ⅱ,Ⅲ,Ⅳ,Ⅴ）.The investigators collect this information from the anesthesia record.

    Measured: Baseline (within laparoscopic surgery)

  6. operative position

    Compare operative position difference between two groups.The operative position include lateral position,trendelenburg position and feet-down tilt position.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  7. peritoneal drainage

    Compare the use of peritoneal drainage difference(used or unused) between two groups.The investigators collect this information from operation record.

    Measured: within laparoscopic surgery

  8. operative duration

    Compare operative duration(minutes) between two groups.The investigators collect this information from operation record.

    Measured: within laparoscopic surgery

  9. the use of sufentanil

    Compare the use of sufentanil difference(used or unused)between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  10. the use of fentanyl

    Compare the use of fentanyl difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  11. the use of remifentanil

    Compare the use of remifentanil difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  12. the use of morphine

    Compare the use of morphine difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  13. the use of butophanol

    Compare the use of butophanol difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  14. the use of sevoflurane

    Compare the use of sevoflurane difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  15. the use of flubiprofen

    Compare the use of flubiprofen difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  16. the use of parecoxib

    Compare the use of parecoxib difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  17. the use of dezocine

    Compare the use of dezocine difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  18. the use of tramadol

    Compare the use of tramadol difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  19. the use of intravenous lidocaine

    Compare the use of intravenous lidocaine difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  20. the use of dexamethasone

    Compare the use of dexamethasone difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  21. the use of methylprednisolone

    Compare the use of methylprednisolone difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  22. the use of deep neuromuscular block

    Compare the use of deep neuromuscular block difference(used or unused) when undergoing general anesthesia between two groups.Neuromuscular block was monitored using post-tetanic-count(PTC) stimulation by a muscle relaxation monitor.If the PTC is within 1-2,the neuromuscular block of patient is deep.If not, the neuromuscular block of patient is not deep.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  23. the use of peripheral nerve block

    Compare the use of peripheral nerve block difference(used or unused) when undergoing general anesthesia between two groups.The types of peripheral nerve block in our study include ilioinguinal and iliohypogastric nerve blocks,transversus abdominis plane block(TAP) and rectus sheath block(RSB).Patients who using any kind of the above peripheral nerve block belong to the group that is using peripheral nerve block when undergoing general anesthesia.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  24. the use of tracer-site infiltration with ropinvacaine

    Compare the use of tracer-site infiltration with ropinvacaine difference(used or unused) when undergoing general anesthesia between two groups.The investigators collect this information from the anesthesia record.

    Measured: within laparoscopic surgery

  25. the use of patient-controlled intravenous analgesia

    Compare the use of patient-controlled intravenous analgesia(PCIA) difference(used or unused) after laparoscopic surgery.The drugs for patients using PCIA to control pain are different but the investigators ignore the difference of the drug composition.As long as the patient uses PCIA,he or she belongs to the using group.The investigators collect this information from the anesthesia record.

    Measured: two days after laparoscopic surgery

Secondary outcomes (1)

  1. incidence of postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia

    Calculate and find out the incidence of postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia.First,the investigators pay the follow-up visit to the patients two days after laparoscopy asking them vocally if they have postoperative shoulder-tip pain.Then the investigators count the number of people who have postoperative shoulder-tip pain after laparoscopic surgery(N1) and the number of people who don't have postoperative shoulder-tip pain after laparoscopic surgery(N2).Finally, the incidence of postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia (%)is calculated with the formula,N1/(N1+N2).(N1+N2)is equal to the total number of the patients entering our study.

    Measured: two months after laparoscopic surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start1 Jun 2019
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
1,311 participants (actual)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386603
Sponsor's protocol ID
KS20190903004-FS02
Status last verified
May 2020
First submitted
4 May 2020
Last updated
19 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Song T, Kim KH, Lee KW. The Intensity of Postlaparoscopic Shoulder Pain Is Positively Correlated with the Amount of Residual Pneumoperitoneum. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):984-989.e1. doi: 10.1016/j.jmig.2017.06.002. Epub 2017 Jun 7.

    PubMed 28602786

  • Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.

    PubMed 8694166

  • Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.

    PubMed 24374246

  • Hsu KF, Chen CJ, Yu JC, Wu SY, Chen BC, Yang CW, Chen TW, Hsieh CB, Chan DC. A Novel Strategy of Laparoscopic Insufflation Rate Improving Shoulder Pain: Prospective Randomized Study. J Gastrointest Surg. 2019 Oct;23(10):2049-2053. doi: 10.1007/s11605-018-3896-5. Epub 2018 Oct 8.

    PubMed 30298416

  • Williams WH 3rd, Cata JP, Lasala JD, Navai N, Feng L, Gottumukkala V. Effect of reversal of deep neuromuscular block with sugammadex or moderate block by neostigmine on shoulder pain in elderly patients undergoing robotic prostatectomy. Br J Anaesth. 2020 Feb;124(2):164-172. doi: 10.1016/j.bja.2019.09.043. Epub 2019 Nov 26.

    PubMed 31780139

  • Wada S, Fukushi Y, Nishimura M, Matsumoto S, Takimoto K, Imai K, Ota H, Tsuzuki Y, Nakajima A, Fujino T. Analysis of risk factors of postlaparoscopic shoulder pain. J Obstet Gynaecol Res. 2020 Feb;46(2):310-313. doi: 10.1111/jog.14156. Epub 2020 Jan 20.

    PubMed 31958892

  • Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.

    PubMed 23340814

Questions about this trial

What is this clinical trial studying?

An observational study of Laparoscopic Surgery and Anesthesia, run by Shenzhen Second People's Hospital at 1 site in China.

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 13 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 19 May 2020. 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 China. 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?

inpatient department (time frame: Baseline (before laparoscopic surgery)). The study lists 25 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 NCT04386603, which also lists 7 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 19 May 2020.

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