Reducing Shoulder Tip Pain Following Laparoscopic Surgery

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01135836

Enrollment

180

Registered

2010-06-03

Start date

2009-08-31

Completion date

2010-09-30

Last updated

2010-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain, Laparoscopic Surgery

Keywords

Shoulder pain, Gynecologic laparoscopic surgery, Nausea, Vomiting, Abdominal fullness

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.

Interventions

PROCEDUREPulmonary 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.

PROCEDUREIntraperitoneal 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.

PROCEDUREControl group

CO2 was removed by passive exsufflation through the port site.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
the severity and frequency of shoulder-tip pain after laparoscopic surgery	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

Measure	Time frame	Description
Nausea or abdominal fullness after laparoscopic surgery	the first 48 hours after the surgery	Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.

Countries

Taiwan

Contacts

Primary ContactYi-Jen Chen, Ph.D.

chenyj@vghtpe.gov.tw886-2-28757566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026