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Clinical Trials/NCT01433874
NCT01433874UnknownPhase 3

Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery

Taipei Veterans General Hospital, Taiwan2 sites in 1 country200 target enrollmentStarted: February 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
200
Locations
2
Primary Endpoint
The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery

Study Overview

Brief Summary

Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.

The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.

Detailed Description

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative upper abdominal and shoulder pain after laparoscopic surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients receive benign gynecological laparoscopic surgery
  • American Society of Anesthesiologists(ASA) physical status of patient classification I-II.

Exclusion Criteria

  • The procedure will be required to conversion to laparotomy
  • Any cardio-vascular diseases

Outcomes

Primary Outcomes

The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery

Time Frame: The first 48 hours after the surgery

The investigators will follow the patient in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder and upper abdominal pain after laparoscopic surgery.

Secondary Outcomes

  • nausea or abdominal fullness after laparoscopic surgery(The first 38 hours after the surgery)

Investigators

Sponsor Class
Other Gov

Study Sites (2)

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