Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position
NCT ID: NCT04129385
Last Updated: 2019-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2016-03-01
2018-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group S
Control group (Group S: 54 patients); this group will undergo the standard laparoscopic procedure (the procedure is done in Trendelenburg position). While in Trendelenburg position and prior to wound closure and with laparoscopic port valves open, the patient's abdomen will be passively deflated. The patients will be placed in supine head up position in the post anesthesia care unit (PACU).
No interventions assigned to this group
Group T
Intervention group (Group T: 54 patients); the patients will be subject to the same maneuver as in arm 1 prior to wound closure but will be positioned in a 20 degree Trendelenburg position once fully awake and cooperative in the PACU and will remain in this position for the first 24 hours post operatively, even after they are transferred to their rooms on the American University of Beirut Medical Center (AUBMC) floors. The maximum time allowed in a straight-up position will be three 15-minute intervals over a 24-hour period (the first interval being a clear fluids intake at 12 hours postoperatively).
20 degree Trendelenburg position
The patients in the intervention group will be placed in trendelenburg position postoperatively.
Interventions
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20 degree Trendelenburg position
The patients in the intervention group will be placed in trendelenburg position postoperatively.
Eligibility Criteria
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Inclusion Criteria
* Age: 18 years to 60 years, American Society of Anesthesiologist physical status (ASA) 1 or 2
* Diagnostic or operative gynecologic laparoscopy {4 port sites, three 5 mm trocars (suprapubic, right and left iliac fossa) and one 10 mm trocar (umbilical)} between one and 3 hours duration.
* Abdominal incisions less than 1.5 cm.
* Steady abdominal insufflation pressure of 14 mm Hg following a gradual insufflation over a 5-minute period.
* Insufflation at a steady maximal flow of 30 l/min
Exclusion Criteria
* Abdominal insufflation pressure more than 14 mm Hg.
* Medical drug allergy to paracetamol, ketoprofen and/or tramadol.
* Presence of gastro-esophageal reflux (GERD)
* Pregnancy
* Patient with Thrombophilias and or at high risk of Deep Vein Thrombosis (DVT)
* Obesity body mass index (BMI) greater than 40
* One day surgery patients
18 Years
60 Years
FEMALE
No
Sponsors
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American University of Beirut Medical Center
OTHER
Responsible Party
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Joseph Nassif
Assistant Professor, Department of Obstetrics & Gynecology
Principal Investigators
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Joseph Nassif, M.D.
Role: PRINCIPAL_INVESTIGATOR
American University of Beirut Medical Center
Locations
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American University of Beirut Medical Center
Beirut, , Lebanon
Countries
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References
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Barnett JC, Hurd WW, Rogers RM Jr, Williams NL, Shapiro SA. Laparoscopic positioning and nerve injuries. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):664-72; quiz 673. doi: 10.1016/j.jmig.2007.04.008. No abstract available.
Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
Madsen MR, Jensen KE. Postoperative pain and nausea after laparoscopic cholecystectomy. Surg Laparosc Endosc. 1992 Dec;2(4):303-5.
Coventry DM. Anaesthesia for laparoscopic surgery. J R Coll Surg Edinb. 1995 Jun;40(3):151-60.
Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996 Oct;6(5):375-9.
Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.
Kojima Y, Yokota S, Ina H. Shoulder pain after gynaecological laparoscopy caused by arm abduction. Eur J Anaesthesiol. 2004 Jul;21(7):578-9. doi: 10.1017/s0265021504267126. No abstract available.
Lepner U, Goroshina J, Samarutel J. Postoperative pain relief after laparoscopic cholecystectomy: a randomised prospective double-blind clinical trial. Scand J Surg. 2003;92(2):121-4.
Berberoglu M, Dilek ON, Ercan F, Kati I, Ozmen M. The effect of CO2 insufflation rate on the postlaparoscopic shoulder pain. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):273-7. doi: 10.1089/lap.1998.8.273.
Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.
Nezhat, C. and F. Nezhat, Nezhat's Operative Gynecologic Laparoscopy and Hysteroscopy2008: Cambridge University Press.
Suginami R, Taniguchi F, Suginami H. Prevention of postlaparoscopic shoulder pain by forced evacuation of residual CO(2). JSLS. 2009 Jan-Mar;13(1):56-9.
Zeeni C, Chamsy D, Khalil A, Abu Musa A, Al Hassanieh M, Shebbo F, Nassif J. Effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures: a randomized clinical trial. BMC Anesthesiol. 2020 Jan 29;20(1):27. doi: 10.1186/s12871-020-0946-9.
Other Identifiers
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AmericanUBMC1
Identifier Type: -
Identifier Source: org_study_id
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