The Effect of Hot Application on Post Laparoscopic Shoulder Pain and Analgesic Use

Sponsor
Cukurova University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05334797
Collaborator
(none)
60
1
2
12
5

Study Details

Study Description

Brief Summary

The aim of this study; To evaluate the effect of hot application on postlaparoscopic shoulder pain and analgesic use in patients undergoing upper laparoscopic surgery in general surgery.

Condition or Disease Intervention/Treatment Phase
  • Other: hot application
N/A

Detailed Description

Among the advantages of laparoscopic surgery; smaller incisions, less postoperative pain, less need for analgesia, shorter hospital stay, earlier return to normal activities and lower morbidity. However, laparoscopic surgery is associated with postoperative shoulder pain, which is rarely seen in open surgeries. The precise mechanism of postlaparoscopic shoulder pain (PLOA) is unclear, but it is believed that the carbon dioxide remaining after laparoscopic surgery causes shoulder pain by causing irritation of the phrenic nerve. In some cases, PLOA may cause more discomfort to the patient than incisional pain.

Hot application is an effective method used to relieve pain. Hot application activates the gate control mechanism, stimulating tactile receptors, reducing ischemic pain with vasodilation, removing metabolic wastes, increasing the release of endorphins, eliminating muscle spasm, reducing effects such as pressure, stretching and hypoxia on nerve endings as a result of changes in the viscoelastic properties of tissues, raising the pain threshold, It reduces or relieves pain by sedating and creating relief in the patient.

Hot application is easy to use, inexpensive, requires no prior application, and has minimal adverse side effects when used correctly. Heat sources include a hot water heater, an electric heating pad, a warm blanket, and a warm bath or shower. In addition to being used as a pain reliever, heat is used to relieve chills or shivering, reduce joint stiffness, reduce muscle spasm, and increase connective tissue extensibility.

In the study of Mohamed et al., in which they examined the effect of hot application and early mobilization on shoulder pain, in the experimental group patients who received hot application; Postoperative shoulder pain was found to be significantly less than the control group at different evaluation times at 4 hours after surgery and at 6, 12 and 24 hours (p<0.001).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Hot Application on Shoulder Pain and Analgesic Use After Laparoscopic Upper Abdominal Surgery
Actual Study Start Date :
Apr 12, 2022
Anticipated Primary Completion Date :
Sep 12, 2022
Anticipated Study Completion Date :
Apr 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hot application

After the patients come to the service after the surgery, a thermophore filled with hot water will be placed on the patient's shoulder according to the presence of shoulder pain and it will be ensured that he stays for 15 minutes. Pain assessment will be done before and after the application. However, 0-2-4-8-12-24. Routine pain assessment will be done at In addition, the type, route, effect and amount of analgesic done in this process will also be recorded. Response evaluation will follow. Response evaluation will follow. Hot application will be applied to every shoulder pain reported by the patients.

Other: hot application
a thermophore filled with hot water will be placed on the patient's shoulder according to the presence of shoulder pain and it will be ensured that he stays for 15 minutes.

No Intervention: control group

First, an individual information form will be filled in for the control group patients who meet the sampling criteria. 0-2-4-8-12-24 after the patients come to the service after the surgery. Routine pain assessment will be done at In addition, the type, route, effect and amount of analgesic done in this process will also be recorded. Response evaluation will follow.

Outcome Measures

Primary Outcome Measures

  1. change of pain [24 hours]

    Numerical Pain Rating Scale (NRS) The form used by Williamson & Hoggart (2005) to assess pain, patients will be asked to select a number from 0 to 10 that best describes their current pain. 0 means no pain and 10 means severe pain. It will be scored as no pain (0), mild pain (1-3), moderate (4-7) and severe pain (8-10).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Agreeing to participate in the research,

  2. Having undergone laparoscopic abdominal surgery

  3. Those who have no previous history of surgery

Exclusion Criteria:
  1. Those who did not agree to participate in the research

  2. Those who have had previous abdominal surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tarsus Universty Mersin Tarsus Turkey 33400

Sponsors and Collaborators

  • Cukurova University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Derya Gezer, Assistant Professor, Cukurova University
ClinicalTrials.gov Identifier:
NCT05334797
Other Study ID Numbers:
  • PLSP
First Posted:
Apr 19, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Derya Gezer, Assistant Professor, Cukurova University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022