Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position

NCT04129385 | Completed

• 1 other identifier: AmericanUBMC1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Pain

Keywords

laparoscopy; shoulder pain; trendelenburg position

Outcome Measures

Primary Outcomes (1)

• Shoulder pain (12 hours)

  Pain score (measured using a 0-10 numerical scale) at 12 hours

  12 hours after laparoscopic surgery

Secondary Outcomes (6)

• Shoulder pain

  at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery

• Presence of nausea

  at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery

• Severity of Nausea

  at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery

• Rescue pain medication

  within first 24 hours after laparoscopic surgery

• Total rescue pain medication

  within first 24 hours after laparoscopic surgery

Study Arms (2)

Group S

NO INTERVENTION

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).

Group T

EXPERIMENTAL

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).

Procedure: 20 degree Trendelenburg position

Interventions

20 degree Trendelenburg position PROCEDURE

The patients in the intervention group will be placed in trendelenburg position postoperatively.

Group T

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, 1103, Lebanon

Location

Related Publications (14)

• 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.

  PMID: 17848335 BACKGROUND

• Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.

  PMID: 9389858 BACKGROUND

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

  PMID: 1341550 BACKGROUND

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

  PMID: 7616466 BACKGROUND

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

  PMID: 8890423 BACKGROUND

• 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.

  PMID: 8694166 BACKGROUND

• 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.

  PMID: 15318475 BACKGROUND

• 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.

  PMID: 12841551 BACKGROUND

• 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.

  PMID: 9820719 BACKGROUND

• 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.

  PMID: 25361653 BACKGROUND

• 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.

  PMID: 20604657 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 19366542 BACKGROUND

• 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.

  PMID: 31996139 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Nassif, M.D.

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: October 16, 2019
• Study Start: March 1, 2016
• Primary Completion: June 20, 2018
• Study Completion: June 28, 2018
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)