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


- candidate number19541
- NTR NumberNTR4812
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2014
- Secondary IDsPOLAR-1 
- Public TitlePostlaparoscopic reduction of pain by combining intraperitoneal normal saline and the pulmonary recruitment maneuver
- Scientific TitlePostlaparoscopic reduction of pain by combining intraperitoneal normal saline and the pulmonary recruitment maneuver
- ACRONYMPOLAR BEAR trial
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedLaparoscopy, Shoulder pain
- Inclusion criteriaWomen 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate1-dec-2015
- Target number of participants126
- InterventionsIn 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.
- Primary outcomeThe 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 outcomeThe secondary outcomes are postoperative use of pain medication, nausea and vomiting, and pulmonary complications.
- TimepointsPatients will receive questionnaires to record pain scores, other complaints, and use of pain medication at 8, 24 and 48 hours postoperative.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. J.E.W. Dijk, van
- CONTACT for SCIENTIFIC QUERIESDr. Marlies Bongers
- Sponsor/Initiator Maastricht University Medical Center (MUMC+), Maxima Medisch Centrum Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryShoulder 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.
- Main changes (audit trail)
- RECORD24-sep-2014 - 28-okt-2015


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