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
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- the severity and frequency of shoulder-tip 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
pulmonary recruitment maneuver
a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anestheiologist held the fifth positive pressure inflation for approximately 5 seconds.
Intervention: Pulmonary recruitment maneuver (Procedure)
intraperitoneal normal saline
the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity
Intervention: Intraperitoneal normal saline (Procedure)
Control group
CO2 was removed by passive exsufflation through the port site.
Intervention: Control group (Procedure)
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)