A promising strategy to reduce postlaparoscopic shoulder pain and abdominal pain is the pulmonary recruitment maneuver. By using manual pulmonary inflations, the intraperitoneal pressure increases and removal of residual carbon dioxide will be…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The secondary outcomes are postoperative use of pain medication, nausea and
vomiting, and pulmonary problems.
Background summary
Shoulder pain and pain in the upper abdomen are common complaints after
laparoscopy. The incidence of shoulder pain ranges from 35 to 80%. Sometimes
this laparoscopy-related pain is even worse than the pain at the incision site.
Laparoscopy*induced pain is thought to be caused by retention of carbon dioxide
in the abdomen, which irritates the phrenic nerve and diaphragm and causes
referred pain in the shoulder and pain in the upper abdomen.
Study objective
A promising strategy to reduce postlaparoscopic shoulder pain and abdominal
pain is the pulmonary recruitment maneuver. By using manual pulmonary
inflations, the intraperitoneal pressure increases and removal of residual
carbon dioxide will be facilitated. Another method is the use of
intraperitoneal normal saline infusion. As carbon dioxide is lighter than
normal saline, it rises and escapes the abdomen more easily. Besides, normal
saline is thought to offer as a physiologic buffer system to dissolve excess
carbon dioxide. In this randomized study, reduction of postlaparoscopic pain
will be estimated by using a combination of the two therapies mentioned.
Study design
Randomized controlled trial, in two teaching hospitals in the Netherlands.
Intervention
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 placed in Trendelenburg position (30
degrees), and the anesthesiologist will perform five manual pulmonary
insufflations with a pressure of maximum 40 cm H2O (pulmonary recruitment
maneuver). The fifth positive pressure inflation will be held for 5 seconds.
The trocar sleeve valves will be left open, so the carbon dioxide can escape
the abdominal cavity. Then de patient is placed in neutral position and the
instruments are removed from the abdomen.
In the control group, the carbon dioxide is removed from the abdominal cavity
at the end of the surgery, with gentle abdominal pressure and passive
exsufflation through the port sites, with the sleeve valves open.
Study burden and risks
Previous studies show that intraperitoneal normal saline infusion is a safe
procedure. Likewise, the pulmonary recruitment maneuver is a proven safe
procedure when inflating with a maximum pressure of 40 cm H2O. Literature shows
there are no related complications with these two interventions. Participants
fill out short questionnaires at three different moments, 8, 24 and 48 hours
after surgery. 24 Hours postoperative, patients are phoned to ask for (serious)
adverse events. The expected benefit is a decrease in incidence and severity of
pain in shoulder and upper abdomen after laparoscopic surgery.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
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
-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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL50655.015.14 |