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Completed

NCT Number: NCT04386603

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Primary outcomes

  1. inpatient department

    Time frame: Baseline (before laparoscopic surgery)

    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.

  2. sex

    Time frame: Baseline (before laparoscopic surgery)

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

  3. age

    Time frame: Baseline (before laparoscopic surgery)

    Compare age difference between two groups.

  4. body mass index(BMI)

    Time frame: Baseline (before laparoscopic surgery)

    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.

  5. ASA grade

    Time frame: Baseline (within laparoscopic surgery)

    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.

  6. operative position

    Time frame: within laparoscopic surgery

    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.

  7. peritoneal drainage

    Time frame: within laparoscopic surgery

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

  8. operative duration

    Time frame: within laparoscopic surgery

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

  9. the use of sufentanil

    Time frame: within laparoscopic surgery

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

  10. the use of fentanyl

    Time frame: within laparoscopic surgery

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

  11. the use of remifentanil

    Time frame: within laparoscopic surgery

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

  12. the use of morphine

    Time frame: within laparoscopic surgery

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

  13. the use of butophanol

    Time frame: within laparoscopic surgery

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

  14. the use of sevoflurane

    Time frame: within laparoscopic surgery

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

  15. the use of flubiprofen

    Time frame: within laparoscopic surgery

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

  16. the use of parecoxib

    Time frame: within laparoscopic surgery

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

  17. the use of dezocine

    Time frame: within laparoscopic surgery

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

  18. the use of tramadol

    Time frame: within laparoscopic surgery

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

  19. the use of intravenous lidocaine

    Time frame: within laparoscopic surgery

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

  20. the use of dexamethasone

    Time frame: within laparoscopic surgery

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

  21. the use of methylprednisolone

    Time frame: within laparoscopic surgery

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

  22. the use of deep neuromuscular block

    Time frame: within laparoscopic surgery

    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.

  23. the use of peripheral nerve block

    Time frame: within laparoscopic surgery

    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.

  24. the use of tracer-site infiltration with ropinvacaine

    Time frame: within laparoscopic surgery

    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.

  25. the use of patient-controlled intravenous analgesia

    Time frame: two days after laparoscopic surgery

    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.

Secondary outcomes

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

    Time frame: two months after laparoscopic surgery

    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.

Sponsors and collaborators

Lead sponsor

Shenzhen Second People's Hospital

Other

Collaborators

  • Shenzhen Third People's Hospital

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 13, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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