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Clinical Trials/NCT01135836
NCT01135836
Unknown
Phase 3

A Randomized, Controlled, Single Blind Study Comparing a Pulmonary Recruitment Maneuver Versus Intraperitoneal Infusion of Normal Saline to Reduce Shoulder Tip Pain After Gynecologic Laparoscopic Surgery

Taipei Veterans General Hospital, Taiwan1 site in 1 country180 target enrollmentAugust 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Shoulder Pain
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
180
Locations
1
Primary Endpoint
the severity and frequency of shoulder-tip pain after laparoscopic surgery
Last Updated
15 years ago

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 reduce carbon dioxide retention in the pelvic cavity.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
September 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients receive benign gynaecological 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 shoulder-tip pain after laparoscopic surgery

Time Frame: the first 48 hours after the surgery

We will follow the patients in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder-tip pain after laparoscopic surgery. The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder-tip pain after laparoscopic surgery.

Secondary Outcomes

  • Nausea or abdominal fullness after laparoscopic surgery(the first 48 hours after the surgery)

Study Sites (1)

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