No registrations found.
ID
Source
Brief title
Health condition
laparoscopy; laparoscopie
shoulder pain; schouderpijn
intraperitoneal saline; fysiologisch zout intraperitoneaal
pulmonary recruitment maneuver
Sponsors and support
Máxima Medisch Centrum Veldhoven
De Run 4600, 5504 DB Veldhoven
e-mail: M.Bongers@mmc.nl
Phone (office): +31 40 888 8384
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 complications.
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. 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. Normal saline offers 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 objective
In this randomized study, reduction of incidence and intensity of postlaparoscopic pain will be estimated by using a combination of two therapies, intraperitoneal normal saline and the pulmonary recruitment maneuver.
Study design
Patients will receive questionnaires to record pain scores, other complaints, and use of pain medication at 8, 24 and 48 hours postoperative.
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 the 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.
Resident obstetrics/gynecology
Maastricht Universitair Medisch Centrum
P. Debyelaan 25
Maastricht 6229 HX
The Netherlands
+31 43 387 4800
jew.vandijk@gmail.com
Resident obstetrics/gynecology
Maastricht Universitair Medisch Centrum
P. Debyelaan 25
Maastricht 6229 HX
The Netherlands
+31 43 387 4800
jew.vandijk@gmail.com
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 laparotomy before
-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 |
---|---|
NTR-new | NL4643 |
NTR-old | NTR4812 |
Other | : POLAR-1 |