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

Completed

• Conditions: Laparoscopic Surgery; Anesthesia

• Registration Number: NCT04386603
• Lead Sponsor: Shenzhen Second People's Hospital

Brief Summary

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

• Study Start: 2019-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Last Update Submitted: 2020-05-17
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1311

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sex	Baseline (before laparoscopic surgery)	Compare sex(male or female)difference between two groups.
age	Baseline (before laparoscopic surgery)	Compare age difference between two groups.
body mass index(BMI)	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.
peritoneal drainage	within laparoscopic surgery	Compare the use of peritoneal drainage difference(used or unused) between two groups.The investigators collect this information from operation record.
the use of patient-controlled intravenous analgesia	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.
operative position	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.
operative duration	within laparoscopic surgery	Compare operative duration(minutes) between two groups.The investigators collect this information from operation record.
the use of sufentanil	within laparoscopic surgery	Compare the use of sufentanil difference(used or unused)between two groups.The investigators collect this information from the anesthesia record.
the use of fentanyl	within laparoscopic surgery	Compare the use of fentanyl difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of sevoflurane	within laparoscopic surgery	Compare the use of sevoflurane difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of flubiprofen	within laparoscopic surgery	Compare the use of flubiprofen difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
inpatient department	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.
the use of remifentanil	within laparoscopic surgery	Compare the use of remifentanil difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of intravenous lidocaine	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.
the use of dexamethasone	within laparoscopic surgery	Compare the use of dexamethasone difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of deep neuromuscular block	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.
the use of tracer-site infiltration with ropinvacaine	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.
ASA grade	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.
the use of dezocine	within laparoscopic surgery	Compare the use of dezocine difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of methylprednisolone	within laparoscopic surgery	Compare the use of methylprednisolone difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of morphine	within laparoscopic surgery	Compare the use of morphine difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of butophanol	within laparoscopic surgery	Compare the use of butophanol difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of parecoxib	within laparoscopic surgery	Compare the use of parecoxib difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of tramadol	within laparoscopic surgery	Compare the use of tramadol difference(used or unused) between two groups.The investigators collect this information from the anesthesia record.
the use of peripheral nerve block	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.

Secondary Outcome Measures

Name	Time	Method
incidence of postoperative shoulder-tip pain after laparoscopic surgery undergoing general anesthesia	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.

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China