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

NCT06195176 | Recruiting

• 1 other identifier: 2022-1-40
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial aimed at understanding the impact of a shoulder exercise routine on postoperative shoulder pain in patients who have undergone laparoscopic hysterectomy. \*\*Main Questions:\*\* 1\. Does implementing a shoulder exercise routine immediately after laparoscopic hysterectomy reduce postoperative shoulder pain? \*\*Brief Explanation:\*\* We want to see if doing shoulder exercises right after laparoscopic hysterectomy can help reduce the pain they might feel in their shoulders. This kind of pain can happen because of the gas used during the surgery. Using exercises could be a cost-effective and easy way to help patients recover better after the surgery. \*\*Hypothesis:\*\* We think that doing shoulder exercises right after laparoscopic hysterectomy will lower the amount of shoulder pain patients experience after the surgery. \*\*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.

Conditions

Postoperative Pain; Laparoscopic Hysterectomy for Benign Conditions

Keywords

LAPAROSCOPIC HYSTERECTOMY; SHOULDER PAIN; EXERCISE; POSTOPERATIVE PAIN

Outcome Measures

Primary Outcomes (1)

• Shoulder pain

  Shoulder pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders.

  6 hours, 24 hours, and 7 days postoperatively

Secondary Outcomes (2)

• Visceral Pain

  6 hours, 24 hours, and 7 days postoperatively

• Incisional Pain

  6 hours, 24 hours, and 7 days postoperatively

Study Arms (2)

SHOULDER EXERCISES

EXPERIMENTAL

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

Other: Shoulder exercises

HAND EXERCISES

SHAM COMPARATOR

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.

Other: Hand exercises

Interventions

Shoulder exercises OTHER

Operational Definition: * Lift the shoulders as high as possible toward the ears. * Maintain this position for 3 seconds. * Rest. * Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward. * Suspend during the night.

SHOULDER EXERCISES

Hand exercises OTHER

Operational Definition: * Open and close the hands, making a fist and applying force. * Maintain this position for 3 seconds. * Rest. * Repeat 10 times at the beginning of each hour during the immediate postoperative period on the hospital ward. * Suspend during the night.

HAND EXERCISES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with preoperative shoulder pain.
• Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery.
• Patients who received a postoperative analgesia pump.
• Patients participating in another protocol

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead

Study Sites (1)

National Institute of Perinatology

Mexico City, Mexico City, 11000, Mexico

RECRUITING

Related Publications (11)

• Yang SC, Chang KY, Wei LF, Shyr YM, Ho CM. To drain or not to drain: the association between residual intraperitoneal gas and post-laparoscopic shoulder pain for laparoscopic cholecystectomy. Sci Rep. 2021 Jun 1;11(1):7447. doi: 10.1038/s41598-021-85714-4.

  PMID: 34059697 BACKGROUND

• Lee DH, Song T, Kim KH, Lee KW. Incidence, natural course, and characteristics of postlaparoscopic shoulder pain. Surg Endosc. 2018 Jan;32(1):160-165. doi: 10.1007/s00464-017-5651-5. Epub 2017 Jun 22.

  PMID: 28643053 BACKGROUND

• Wada S, Fukushi Y, Nishimura M, Matsumoto S, Takimoto K, Imai K, Ota H, Tsuzuki Y, Nakajima A, Fujino T. Analysis of risk factors of postlaparoscopic shoulder pain. J Obstet Gynaecol Res. 2020 Feb;46(2):310-313. doi: 10.1111/jog.14156. Epub 2020 Jan 20.

  PMID: 31958892 BACKGROUND

• van Dijk J, Dedden SJ, Geomini P, van Kuijk S, van Hanegem N, Meijer P, Bongers MY. Randomised controlled trial to estimate reduction in pain after laparoscopic surgery when using a combination therapy of intraperitoneal normal saline and the pulmonary recruitment manoeuvre. BJOG. 2018 Oct;125(11):1469-1476. doi: 10.1111/1471-0528.15207. Epub 2018 Apr 15.

  PMID: 29498786 BACKGROUND

• Reeve J, Stiller K, Nicol K, McPherson KM, Birch P, Gordon IR, Denehy L. A postoperative shoulder exercise program improves function and decreases pain following open thoracotomy: a randomised trial. J Physiother. 2010;56(4):245-52. doi: 10.1016/s1836-9553(10)70007-2.

  PMID: 21091414 BACKGROUND

• Klein I, Kalichman L, Chen N, Susmallian S. A pilot study evaluating the effect of early physical therapy on pain and disabilities after breast cancer surgery: Prospective randomized control trail. Breast. 2021 Oct;59:286-293. doi: 10.1016/j.breast.2021.07.013. Epub 2021 Jul 21.

  PMID: 34340163 BACKGROUND

• Tanner TN, Hall BR, Oran J. Pneumoperitoneum. Surg Clin North Am. 2018 Oct;98(5):915-932. doi: 10.1016/j.suc.2018.06.004.

  PMID: 30243453 BACKGROUND

• Yamamoto-Furusho JK, Sarmiento-Aguilar A, Garcia-Alanis M, Gomez-Garcia LE, Toledo-Maurino J, Olivares-Guzman L, Fresan-Orellana A. Hospital Anxiety and Depression Scale (HADS): Validation in Mexican Patients with Inflammatory Bowel Disease. Gastroenterol Hepatol. 2018 Oct;41(8):477-482. doi: 10.1016/j.gastrohep.2018.05.009. Epub 2018 Jun 21. English, Spanish.

  PMID: 29937084 BACKGROUND

• Bastamizad N, Abbasi P, Salari N, Jalali R. Comparing the Effect of Incentive Spirometry and Deep Breathing Exercises on the Level of Shoulder Pain and Nausea Following Laparoscopic Cholecystectomy Surgery: A Clinical Trial Study. Gastroenterol Nurs. 2023 Jan-Feb 01;46(1):14-22. doi: 10.1097/SGA.0000000000000720. Epub 2023 Jan 10.

  PMID: 36706138 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

• Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016.

  PMID: 27499688 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Behavior

Central Study Contacts

ANDREA A OLGUIN-ORTEGA, MD

CONTACT

+5255209900; olguin.andrea@gmail.com

ENRIQUE REYES-MUÑOZ, PHD

CONTACT

+5255209900; dr.enriquereyes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSC

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: January 20, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ME (1)