Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position

Shoulder Pain Clinical Trial

Official title:

Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129385
• Other study ID #: AmericanUBMC1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: June 28, 2018

Study information

• Verified date: October 2019
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg positioning will help displace CO2 from the sub diaphragmatic area thus reducing the diaphragmatic and phrenic nerve irritation causing pain.

Description:

A prospective randomized controlled study with 54 patients in each of the two arms. Group S (control) will undergo the standard laparoscopic procedure and the patients will be placed in supine head up position postoperatively. In group T (interventional); the patients will be positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia case unit (PACU) and will remain in this position for the first 24 hours postoperatively. Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected at arrival to PACU, & 4, 6, 12 and 24 hours postoperatively. In addition, total amount of rescue pain and nausea medication used by the patient will be recorded. Data collected will be analyzed and compared between the two groups. The independent t- test will be used to compare postoperative shoulder pain, with NRS scores treated as continuous variable, between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 28, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female patients

• 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:

• Conversion to laparotomy.

• 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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• 20 degree Trendelenburg position
The patients in the intervention group will be placed in trendelenburg position postoperatively.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

References & Publications (13)

Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Coventry DM. Anaesthesia for laparoscopic surgery. J R Coll Surg Edinb. 1995 Jun;40(3):151-60. Review. — View Citation

Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. — View Citation

Kojima Y, Yokota S, Ina H. Shoulder pain after gynaecological laparoscopy caused by arm abduction. Eur J Anaesthesiol. 2004 Jul;21(7):578-9. — View Citation

Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996 Oct;6(5):375-9. — View Citation

Lepner U, Goroshina J, Samarütel J. Postoperative pain relief after laparoscopic cholecystectomy: a randomised prospective double-blind clinical trial. Scand J Surg. 2003;92(2):121-4. — View Citation

Madsen MR, Jensen KE. Postoperative pain and nausea after laparoscopic cholecystectomy. Surg Laparosc Endosc. 1992 Dec;2(4):303-5. — View Citation

Nezhat, C. and F. Nezhat, Nezhat's Operative Gynecologic Laparoscopy and Hysteroscopy2008: Cambridge University Press.

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain (12 hours)	Pain score (measured using a 0-10 numerical scale) at 12 hours	12 hours after laparoscopic surgery
Secondary	Shoulder pain	Pain score (measured using a 0-10 numerical scale)	at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery
Secondary	Presence of nausea	Presence or absence of nausea (yes/no)	at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Secondary	Severity of Nausea	Nausea score (measured using a 0-10 numerical scale)	at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Secondary	Rescue pain medication	Time to first rescue pain medication (minutes)	within first 24 hours after laparoscopic surgery
Secondary	Total rescue pain medication	Total rescue pain medication during first 24 hours	within first 24 hours after laparoscopic surgery
Secondary	Patient satisfaction	Patient satisfaction with surgical experience (measured using a 0-10 numerical scale)	24 hours post laparoscopic surgery