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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386603
• Other study ID #: KS20190903004-FS02
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Shenzhen Second People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1311
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients over 18 years old (including 18 years old) having gynecologic or gastrointestinal or hepatobiliary surgery undergoing general anesthesia;

2. Patients agreeing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients under 18 years age or having emergency laparoscopic surgery;

2. Patients having laparoscopy but not undergoing general anesthesia;

3. Patients undergoing laparoscopy and having hysteroscopy at the same time.

4. Patients undergoing laparoscopy and having fistulostomy at the same time.

5. Patients having regional thermoperfusion after laparoscopic surgery.

6. Laparoscopy being needed to converse to laparotomy.

7. Patients having shoulder pain or history of periarthritis of shoulder or long-term taking painkillers.

8. Patients having severe psychological problem and unable to cooperate with our study.

9. Patients being sent to ICU for further treatment after operation.

10. Patients being discharged within 2 days after operation and losing contact.

11. Patients having another operation after laparoscopy.

12. Patients taking another painkillers except using patient-controlled intravenous analgesia.

13. Patients refusing to take part in this study.

Related Conditions & MeSH terms

• Anesthesia
• Laparoscopic Surgery

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital	Shenzhen Third People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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 — View Citation

Donatsky AM, Bjerrum F, Gögenur 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. Review. — View Citation

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- — View Citation

Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (before laparoscopic surgery)
Primary	sex	Compare sex(male or female)difference between two groups.	Baseline (before laparoscopic surgery)
Primary	age	Compare age difference between two groups.	Baseline (before laparoscopic surgery)
Primary	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.	Baseline (before laparoscopic surgery)
Primary	ASA grade	Compare ASA grade difference between two groups.The ASA grade includes five grades(?,?,?,?,?).The investigators collect this information from the anesthesia record.	Baseline (within laparoscopic surgery)
Primary	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.	within laparoscopic surgery
Primary	peritoneal drainage	Compare the use of peritoneal drainage difference(used or unused) between two groups.The investigators collect this information from operation record.	within laparoscopic surgery
Primary	operative duration	Compare operative duration(minutes) between two groups.The investigators collect this information from operation record.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	within laparoscopic surgery
Primary	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.	two days after laparoscopic surgery
Secondary	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.	two months after laparoscopic surgery