NCT04386603|CompletedDMC
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Sponsor study identifier
observational
1,311
1 country
1
Study Start
June 1, 2019
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)To find out the risk factors for postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2019
Actual (reported)December 31, 2019
Actual (reported)December 31, 2019
Actual (reported)May 4, 2020
Actual (reported)May 13, 2020
Actual (reported)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.
incidence of postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia
two months after laparoscopic surgery
The patients in this group have postoperative phoulder-tip pain after laparoscopic surgery undergoing general anesthesia.
The patients in this group don't have postoperative phoulder-tip pain after laparoscopic surgery undergoing general anesthesia.
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.
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
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.
Liu Zhiheng, Doctor
Anesthesia department of ShenZhen Second People's Hospital
1,311 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2020
First Posted
May 13, 2020
Study Start
June 1, 2019
Actual (reported)The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
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
Contact the study team to confirm eligibility.
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.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Last Updated
May 19, 2020
Record last verified: 2020-05
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