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

NCT05334797 | Completed

• 1 other identifier: PLSP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Shoulder

Keywords

postlaparoscopic; shoulder pain; analgesic; Hot application

Outcome Measures

Primary Outcomes (2)

• change of pain

  Post-laparoscopic shoulder pain intensity is assessed using the Visual Analogue Scale (VAS), consisting of a 10-cm horizontal line ranging from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity. Pain intensity is assessed at six predefined postoperative intervals: 0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours.

  During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).

• analgesic consumption

  Postoperative analgesic administration is recorded at each predefined assessment interval as whether additional analgesia is administered and, if administered, whether the analgesic is classified as opioid or non-opioid.

  During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).

Study Arms (2)

Hot application

EXPERIMENTAL

Participants allocated to the intervention group receive standardized routine postoperative care plus local heat therapy. Local heat therapy is initiated within the first postoperative hour using a hot-water bag covered with a protective sheath and maintained at a maximum temperature of 55°C. The hot-water bag is positioned beneath the shoulder and applied for 15-20 minutes. The intervention is repeated at 2-hour intervals during the first 24 postoperative hours or until complete resolution of shoulder pain, whichever occurs first. Skin integrity and patient tolerance are monitored before, during, and after each application. Post-laparoscopic shoulder pain intensity is assessed using the Visual Analogue Scale (VAS) at six predefined postoperative intervals: 0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours. In the intervention group, pain intensity is assessed before each heat application and, in both groups, before administration of any additional analgesic medication. Postoperative analge

Other: Local heat therapy

control group

NO INTERVENTION

Participants allocated to the control group receive standardized routine postoperative care only. Post-laparoscopic shoulder pain intensity is assessed using the Visual Analogue Scale (VAS) at six predefined postoperative intervals: 0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours. Pain intensity is assessed before the administration of any additional analgesic medication. Postoperative analgesic administration is monitored throughout the 24-hour observation period, including whether additional analgesia is administered and, when administered, whether the medication is classified as opioid or non-opioid.

Interventions

Local heat therapy OTHER

A hot-water bag covered with a protective sheath is placed beneath the shoulder at a maximum temperature of 55°C. Local heat therapy is initiated within the first postoperative hour and applied for 15-20 minutes at 2-hour intervals during the first 24 postoperative hours or until complete resolution of shoulder pain. Skin integrity and patient tolerance are monitored before, during, and after each application.

Hot application

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years. Scheduled for elective laparoscopic upper abdominal surgery. No previous laparoscopic surgery. ASA physical status I-III. Able to understand and complete the study assessments. Provided written informed consent to participate in the study.

You may not qualify if:

• Undergoing emergency surgery. Cognitive impairment preventing reliable pain self-report.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Tarsus Universty

Mersin, Tarsus, 33400, Turkey (Türkiye)

Location

Related Publications (13)

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  PMID: 10227938 BACKGROUND

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  PMID: 20701547 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

• Li X, Li K. Time Characteristics of Shoulder Pain after Laparoscopic Surgery. JSLS. 2021 Apr-Jun;25(2):e2021.00027. doi: 10.4293/JSLS.2021.00027.

  PMID: 34248341 BACKGROUND

Related Links

• Heating pads and early mobilization for reducing postoperative shoulder pain and enhancing recovery of women undergoing gynecological laparoscopic surgery
• Ağrı kontrolünde farmakolojik olmayan yöntemler

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 19, 2022
• Study Start: April 12, 2022
• Primary Completion: April 12, 2024
• Study Completion: August 19, 2024
• Last Updated: September 24, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)