Randomized Clinical Trial: Effect of an Exercise Routine on Postoperative Shoulder Pain in Total Laparoscopic Hysterectomy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: *\* Our goal is to find out if a shoulder exercise routine can make a difference in how much shoulder pain patients have right after laparoscopic hysterectomy. \*\*How We'll Do It:\*\* This study aims to evaluate the impact of a shoulder exercise routine on reducing postoperative shoulder pain in women who have undergone total laparoscopic hysterectomy at the National Institute of Perinatology. Recognizing the high prevalence and intensity of post-laparoscopy shoulder pain, the study compares the effectiveness of shoulder exercises to hand exercises in managing this pain. Patients, selected based on specific inclusion and exclusion criteria, will be randomly assigned to either the shoulder or hand exercise group. The exercise regimen involves performing specific movements at regular intervals during the immediate postoperative period, except at night. Pain intensity will be measured using a Visual Analog Scale at various intervals postoperatively. The study controls for several variables, including visceral and incisional pain, duration of pneumoperitoneum, analgesic use, and patient characteristics like BMI and comorbidities, to ensure a comprehensive understanding of the exercises' effectiveness. The hypothesis tests whether shoulder exercises can reduce shoulder pain more effectively than hand exercises. This research could have significant implications for enhancing recovery and pain management strategies post-laparoscopy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology.

• Mixed anesthesia.

• Placement of shoulder pads on the surgical table during surgery.

• Adults who agree to participate and sign informed consent.

Locations
Other Locations
Mexico
National Institute of Perinatology
RECRUITING
Mexico City
Contact Information
Primary
ANDREA A OLGUIN-ORTEGA, MD
olguin.andrea@gmail.com
+5255209900
Backup
ENRIQUE REYES-MUÑOZ, PHD
dr.enriquereyes@gmail.com
+5255209900
Time Frame
Start Date: 2024-01-20
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 66
Treatments
Experimental: SHOULDER EXERCISES
Patients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The routine consists of lifting the shoulders as high as possible towards the ears, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended at night. The procedure will be standardized, as the principal investigators will personally explain and demonstrate it to all involved individuals who are responsible for explaining it to the patients. In-person reminders will be made, and pain in the shoulders, incisions, and abdomen will be recorded at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on day post-surgery
Sham_comparator: HAND EXERCISES
Patients randomized to the exercise routine group will be instructed, upon recovery, about the exercise routine. The sham routine consists of tightly opening and closing the hands, holding for 3 seconds, and then resting. This should be repeated 10 times at the beginning of each hour during the immediate postoperative period while on the hospital ward. The routine will be suspended at night. The procedure will be standardized, as the principal investigator will personally explain and demonstrate it to all individuals responsible for instructing the patients. In-person reminders will be issued, and pain in the shoulders, incisions, and abdomen will be recorded at 6 hours and 24 hours postoperatively, as well as during the follow-up consultations on the 7th day after surgery.
Related Therapeutic Areas
Sponsors
Leads: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

This content was sourced from clinicaltrials.gov