Shoulder Pain and Post Gynecologic Laparoscopic Recovery

NCT05344677 | Completed

• 1 other identifier: 1527122021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Gynecologic Nursing; Postoperative Pain

Keywords

Shoulder Pain after Gynecologic Laparoscopic

Outcome Measures

Primary Outcomes (2)

• 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.

  Pain intensity will be evaluated for all groups up to 24 hours postoperative

• 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.

  postoperative recovery will be evaluated for all groups up to 24 hours postoperative

Study Arms (3)

trendlenburg position group

EXPERIMENTAL

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

Other: Trendelenburg Position

warm pad application group

EXPERIMENTAL

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.

Other: Warm Pad Application

deep breathing group

EXPERIMENTAL

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

Behavioral: Deep Breathing Exercise

Interventions

Trendelenburg Position OTHER

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.

trendlenburg position group

Warm Pad Application OTHER

• 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.

warm pad application group

Deep Breathing Exercise BEHAVIORAL

• 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.

deep breathing group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: women were scheduled for diagnostic or operative gynecological laparoscopic surgery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Noha Mohamed Mahmoud Hassan

Alexandria, Egypt

Location

Related Publications (3)

• 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.

  PMID: 23136538 BACKGROUND

• 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.

  PMID: 27679045 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eman Taha

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 25, 2022
• Study Start: May 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 2, 2023

Record last verified: 2022-03

Locations

EG (1)