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Shoulder Pain and Post Gynecologic Laparoscopic Recovery

Primary Purpose

Gynecologic Nursing, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Trendelenburg Position
Warm Pad Application
Deep Breathing Exercise
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Nursing focused on measuring Shoulder Pain after Gynecologic Laparoscopic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age from 18-70 years
  • women who were scheduled for diagnostic or operative gynecological laparoscopic surgery for non-malignant pathologies (e.g., hysterectomy, ovarian cystectomy)
  • Free from any Medical history of deep vein thrombosis,shoulder surgery and chronic shoulder pain.

Exclusion Criteria:

• women with any medical or gynecological risk factors such as, morbid obese (BMI > 45) and pelvic inflammatory disease.

Sites / Locations

  • Noha Mohamed Mahmoud Hassan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

trendlenburg position group

warm pad application group

deep breathing group

Arm Description

in which the women will be positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the recovery room and will remain in this posture for the first 24 hrs postoperatively. The maximum time allowed in a straight-up position will be three 15-min intervals over a 24-h period

in this group warm pad (38◦C -40◦C) will be applied on the shoulder after four hours postoperatively for a period of 5-10 minutes. Each woman will be asked to place heat pads when needed during the first 24 hours.

the researcher will instruct women after the end of surgery and upon consciousness to take slowly deep breathing while observing her chest and hold her breath for about 5 seconds and then exhale slowly, repeating this deep breathing technique five times after full vigilance within the first 3 hours after surgery. Then, the process will be repeated 6, 12, and 24 h later. The patient will be instructed about this type of breathing before surgery by researchers

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale (NRS)
It will be used to assess the severity of shoulder pain. Women will be instructed to choose a number from 0 to 10 that best describes their current pain.
Postoperative Quality of Recovery scale(QoR40)Postoperative Quality of Recovery scale(QoR40)
This tool was originally developed by Myles (2000), it is used to measure quality of recovery. It is consisted of 40 items, the items are grouped according to various aspects (dimensions) of recovery: emotional state (9items), physical comfort (12items), psychological support (7items), physical independence (5 items), and pain (7items). Subjects' response to each item will vary according to a 5 point likert scale, it was scored for positive item as "1= none of the time, 2=some of the time, 3= usually,4=most of time, and 5=all of the time.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2022
Last Updated
January 31, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05344677
Brief Title
Shoulder Pain and Post Gynecologic Laparoscopic Recovery
Official Title
Effect Of Trendelenburg Position, Warm Pad Application and Deep Breathing Exercise on Shoulder Pain and Post Gynecologic Laparoscopic Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The present study aims to investigate the effect of postoperative trendelenburg position versus warm pad application and deep breathing technique on shoulder pain intensity and post gynaecologic laparoscopic recovery
Detailed Description
Laparoscopic gynecologic surgery has evolved from a limited surgical procedure used only for diagnostic purposes to a major surgical approach for treating a multitude of malignant and non-malignant pathologies. It is currently considered one of the most common surgical procedures performed by gynecologists. Laparoscopic surgery, has become widely recognized as a viable alternative to traditional laparotomy in treatment of different gynecologic diseases . The advantages of laparoscopic surgery over traditional laparotomy include a smaller surgical wound, less postoperative pain, a shorter hospital stay, faster recovery, and a better cosmetic result. However, post-laparoscopic shoulder pain (PLSP), is a prevalent complaint following laparoscopic surgery with an incidence as high as 80%. The pain can be severe and is usually relieved in 24-48h, but rarely persists for over 72h after surgery. It has also been found that PLSP is less responsive to treatment than incision and visceral pain. The precise mechanism of post-laparoscopic shoulder pain remains unclear. Carbon dioxide accumulation and phrenic nerve irritation as a result of diaphragmatic stretching are the most accepted explanations. A number of techniques that are proposed to diminish shoulder pain as intraperitoneal instillation of local anesthetics, pulmonary recruitment maneuver, warm and humidified dioxide, low pressure pneumoperitoneum and intraperitoneal normal saline infusion. Unfortunately, these interventions have often found quite varied and sometimes even conflicting results regarding their effectiveness. Optimal pain management is imperative for the success of immediate and long term rehabilitation. Therefore, relieving PLSP is a problem that can no longer be ignored. Effective pain control is best achieved through a combination of both pharmaceutical and non-pharmaceutical therapies. Non pharmacological methods increase women/Patient control of her feeling, improve the activity level and functional capacity and reduce dosage of analgesic drugs thus decreasing the side effects of treatment. One of the popular non-pharmacological techniques is heat therapy, it is easy to use, inexpensive, require no prior practice, and have minimal side effects when used properly. In addition to being used for pain relief, heat is used to relieve chills or trembling, decrease joint stiffness, reduce muscle spasm, and increase connective tissue extensibility Also, one of the recommended non-pharmacological actions is to use deep breathing relaxation techniques. The technique of breathing relaxation itself is an act of nursing care, which in this case the nurse teaches the patients how to do deep breathing techniques, slow breathing (hold inspiration to the maximum) and how to exhale slowly. In addition to reducing pain intensity, deep breathing relaxation techniques can also improve lung ventilation and increase blood oxygenation. In addition, the trendelenburg position might decrease shoulder pain by reducing the mechanical pressure exerted by CO2 on the diaphragm and the upper abdominal muscles. CO2, known for its high solubility, would also be displaced to the pelvis that has a rich vasculature which in turn speeds up the resorption of pneumoperitoneum .However, evidence-based research is still needed in the area of pain relief after gynecologic laparoscopy and few studies have attempted to identify the effect of warm application and trendelenburg position versus deep breathing technique on PLSP. So, the purpose of this study is to determine the effect of postoperative trendelenburg position, warm application, and deep breathing exercise on shoulder pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Nursing, Postoperative Pain
Keywords
Shoulder Pain after Gynecologic Laparoscopic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trendlenburg position group
Arm Type
Experimental
Arm Description
in which the women will be positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the recovery room and will remain in this posture for the first 24 hrs postoperatively. The maximum time allowed in a straight-up position will be three 15-min intervals over a 24-h period
Arm Title
warm pad application group
Arm Type
Experimental
Arm Description
in this group warm pad (38◦C -40◦C) will be applied on the shoulder after four hours postoperatively for a period of 5-10 minutes. Each woman will be asked to place heat pads when needed during the first 24 hours.
Arm Title
deep breathing group
Arm Type
Experimental
Arm Description
the researcher will instruct women after the end of surgery and upon consciousness to take slowly deep breathing while observing her chest and hold her breath for about 5 seconds and then exhale slowly, repeating this deep breathing technique five times after full vigilance within the first 3 hours after surgery. Then, the process will be repeated 6, 12, and 24 h later. The patient will be instructed about this type of breathing before surgery by researchers
Intervention Type
Other
Intervention Name(s)
Trendelenburg Position
Intervention Description
Group 1 (trendlenburg position group) in which the women will be positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the recovery room and will remain in this posture for the first 24 hrs postoperatively. The maximum time allowed in a straight-up position will be three 15-min intervals over a 24-h period.
Intervention Type
Other
Intervention Name(s)
Warm Pad Application
Intervention Description
• Group 2 (warm pad application group) in this group warm pad (38◦C -40◦C) will be applied on the shoulder after four hours postoperatively for a period of 5-10 minutes. Each woman will be asked to place heat pads when needed during the first 24 hours.
Intervention Type
Behavioral
Intervention Name(s)
Deep Breathing Exercise
Intervention Description
• Group 3: (deep breathing group) the researcher will instruct women after the end of surgery and upon consciousness to take slowly deep breathing while observing her chest and hold her breath for about 5 seconds and then exhale slowly, repeating this deep breathing technique five times after full vigilance within the first 3 hours after surgery. Then, the process will be repeated 6, 12, and 24 h later. The patient will be instructed about this type of breathing before surgery by researchers.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NRS)
Description
It will be used to assess the severity of shoulder pain. Women will be instructed to choose a number from 0 to 10 that best describes their current pain.
Time Frame
Pain intensity will be evaluated for all groups up to 24 hours postoperative
Title
Postoperative Quality of Recovery scale(QoR40)Postoperative Quality of Recovery scale(QoR40)
Description
This tool was originally developed by Myles (2000), it is used to measure quality of recovery. It is consisted of 40 items, the items are grouped according to various aspects (dimensions) of recovery: emotional state (9items), physical comfort (12items), psychological support (7items), physical independence (5 items), and pain (7items). Subjects' response to each item will vary according to a 5 point likert scale, it was scored for positive item as "1= none of the time, 2=some of the time, 3= usually,4=most of time, and 5=all of the time.
Time Frame
postoperative recovery will be evaluated for all groups up to 24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women were scheduled for diagnostic or operative gynecological laparoscopic surgery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age from 18-70 years women who were scheduled for diagnostic or operative gynecological laparoscopic surgery for non-malignant pathologies (e.g., hysterectomy, ovarian cystectomy) Free from any Medical history of deep vein thrombosis,shoulder surgery and chronic shoulder pain. Exclusion Criteria: • women with any medical or gynecological risk factors such as, morbid obese (BMI > 45) and pelvic inflammatory disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Taha
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Noha Mohamed Mahmoud Hassan
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
23136538
Citation
Zhang H, Shu H, Yang L, Cao M, Zhang J, Liu K, Xiao L, Zhang X. Multiple-, but not single-, dose of parecoxib reduces shoulder pain after gynecologic laparoscopy. Int J Med Sci. 2012;9(9):757-65. doi: 10.7150/ijms.4916. Epub 2012 Oct 23.
Results Reference
background
PubMed Identifier
27679045
Citation
Sutchritpongsa P, Tossamartworakul M. Pulmonary Recruitment Maneuver for Reducing Postoperative Shoulder Pain Incidence After Laparoscopic Gynecologic Surgery: A Prospective Randomized Controlled Trial. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S204. doi: 10.1016/j.jmig.2015.08.736. Epub 2015 Oct 15. No abstract available.
Results Reference
background
PubMed Identifier
31996139
Citation
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.
Results Reference
background

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Shoulder Pain and Post Gynecologic Laparoscopic Recovery

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