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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Anesthesia

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.

• Study Type: Observational
• Enrollment (Actual): 1311

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518035
      • Shenzhen Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
shoulder-tip pain group; The patients in this group have postoperative phoulder-tip pain after laparoscopic surgery undergoing general anesthesia.
non-shoulder-tip pain group; The patients in this group don't have postoperative phoulder-tip pain after laparoscopic surgery undergoing general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
sex	Compare sex(male or female)difference between two groups.	Baseline (before laparoscopic surgery)
age	Compare age difference between two groups.	Baseline (before laparoscopic surgery)
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)
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.	Baseline (within laparoscopic surgery)
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
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
operative duration	Compare operative duration(minutes) between two groups.The investigators collect this information from operation record.	within laparoscopic surgery
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital
• Collaborators: Shenzhen Third People's Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: laparoscopic surgery; risk factor; postoperative shoulder pain
• Other Study ID Numbers: KS20190903004-FS02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No