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Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
20 degree Trendelenburg position
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Pain focused on measuring laparoscopy, shoulder pain, trendelenburg position

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • American University of Beirut Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group S

Group T

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Shoulder pain
Pain score (measured using a 0-10 numerical scale)
Presence of nausea
Presence or absence of nausea (yes/no)
Severity of Nausea
Nausea score (measured using a 0-10 numerical scale)
Rescue pain medication
Time to first rescue pain medication (minutes)
Total rescue pain medication
Total rescue pain medication during first 24 hours
Patient satisfaction
Patient satisfaction with surgical experience (measured using a 0-10 numerical scale)

Full Information

First Posted
June 28, 2019
Last Updated
October 15, 2019
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04129385
Brief Title
Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position
Official Title
Effect of Postoperative Trendelenburg Position on Shoulder Pain After Gynecological Laparoscopic Procedures.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
laparoscopy, shoulder pain, trendelenburg position

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group S
Arm Type
No Intervention
Arm Description
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).
Arm Title
Group T
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
20 degree Trendelenburg position
Intervention Description
The patients in the intervention group will be placed in trendelenburg position postoperatively.
Primary Outcome Measure Information:
Title
Shoulder pain (12 hours)
Description
Pain score (measured using a 0-10 numerical scale) at 12 hours
Time Frame
12 hours after laparoscopic surgery
Secondary Outcome Measure Information:
Title
Shoulder pain
Description
Pain score (measured using a 0-10 numerical scale)
Time Frame
at arrival to post anesthesia care unit (PACU), 4, 6, and 24 hours, after laparoscopic surgery
Title
Presence of nausea
Description
Presence or absence of nausea (yes/no)
Time Frame
at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Title
Severity of Nausea
Description
Nausea score (measured using a 0-10 numerical scale)
Time Frame
at arrival to PACU, 4, 6, 12 and 24 hours, after laparoscopic surgery
Title
Rescue pain medication
Description
Time to first rescue pain medication (minutes)
Time Frame
within first 24 hours after laparoscopic surgery
Title
Total rescue pain medication
Description
Total rescue pain medication during first 24 hours
Time Frame
within first 24 hours after laparoscopic surgery
Title
Patient satisfaction
Description
Patient satisfaction with surgical experience (measured using a 0-10 numerical scale)
Time Frame
24 hours post laparoscopic surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Nassif, M.D.
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
1103
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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17848335
Citation
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derived

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Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position

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