Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01433874

Enrollment

200

Registered

2011-09-14

Start date

2011-02-28

Completion date

2012-12-31

Last updated

2011-09-14

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

Conditions

Shoulder Pain, Nausea

Keywords

Shoulder pain, Upper abdominal pain, Laparoscopic surgery, 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 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.

Interventions

PROCEDUREPulmonary recruitment maneuver

A pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.

PROCEDUREIntraperitoneal normal saline infusion

The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. We will leave the fluid in the abdominal cavity

PROCEDUREcombined group

The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure oof 60 cmH2O.

PROCEDUREControl group

Co2 was removed by passive exsufflation through the port site.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery	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

Measure	Time frame	Description
nausea or abdominal fullness after laparoscopic surgery	The first 38 hours after the surgery	postoperative illness, such as nausea, vomiting, or abdominal fullness were also recorded.

Countries

Taiwan

Contacts

Primary ContactYi-Jen Chen, M.D., Ph D.

chenyj@vghtpe.gov.tw886-2-2875-7566

Outcome results

None listed

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