Postlaparoscopic reduction of pain by combining intraperitoneal normal saline and the pulmonary recruitment maneuver

Postlaparoscopic reduction of pain by combining intraperitoneal normal saline and the pulmonary recruitment maneuver - POLAR BEAR trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42258

Enrollment

126

Registered

2014-12-17

Start date

2015-02-03

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Postlaparoscopic shoulderpain.

Interventions

In the intervention group, the upper abdomen will be evenly and bilaterally filled with warmed isotonic normal saline (15-20 ml/kg body weight) and left in the abdominal cavity. Then the patient is

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women between 18-65 years of age, ASA classification I-II, who are planned for an elective laparoscopic procedure with a benign gynecologic indication.

Exclusion criteria

Exclusion criteria: -Women who do not speak Dutch -Women younger than 18 years -Women who had a midline laparotomy before -Pregnant women -COPD/Emphysema -Daily use of pain medication -Allergic/intolerance to NSAID*s

Design outcomes

Primary

Measure	Time frame
The primary outcomes are the incidence and intensity of postlaparoscopic pain in shoulder and upper abdomen at 8, 24 and 48 hours after surgery, using the Visual Analog Score scale (VAS scale).	—

Secondary

Measure	Time frame
The secondary outcomes are postoperative use of pain medication, nausea and vomiting, and pulmonary problems.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)