NCT05334797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

April 9, 2022

Last Update Submit

August 19, 2024

Conditions

Keywords

postlaparoscopicshoulder painanalgesicHot application

Outcome Measures

Primary Outcomes (2)

  • change of pain

    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).

    24 hours

  • analgesic consumption

    analgesic consumption form

    24 hours

Study Arms (2)

Hot application

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

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.

Hot application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agreeing to participate in the research,
  • Having undergone laparoscopic abdominal surgery
  • Those who have no previous history of surgery

You may not qualify if:

  • Those who did not agree to participate in the research
  • Those who have had previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus Universty

Mersin, Tarsus, 33400, Turkey (Türkiye)

Location

Related Publications (13)

  • Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P, Osborne H, Bouchier-Hayes D. Reduced postoperative hospitalization after laparoscopic cholecystectomy. Br J Surg. 1991 Feb;78(2):160-2. doi: 10.1002/bjs.1800780209.

    PMID: 1826624BACKGROUND
  • Valla JS, Limonne B, Valla V, Montupet P, Daoud N, Grinda A, Chavrier Y. Laparoscopic appendectomy in children: report of 465 cases. Surg Laparosc Endosc. 1991 Sep;1(3):166-72.

    PMID: 1669397BACKGROUND
  • Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4.

    PMID: 19588344BACKGROUND
  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

    PMID: 23392233BACKGROUND
  • Mouton WG, Bessell JR, Otten KT, Maddern GJ. Pain after laparoscopy. Surg Endosc. 1999 May;13(5):445-8. doi: 10.1007/s004649901011.

    PMID: 10227938BACKGROUND
  • Fredman B, Jedeikin R, Olsfanger D, Flor P, Gruzman A. Residual pneumoperitoneum: a cause of postoperative pain after laparoscopic cholecystectomy. Anesth Analg. 1994 Jul;79(1):152-4.

    PMID: 8010427BACKGROUND
  • Cason CL, Seidel SL, Bushmiaer M. Recovery from laparoscopic cholecystectomy procedures. AORN J. 1996 Jun;63(6):1099-103, 1106-8, 1111-2 passim. doi: 10.1016/s0001-2092(06)63296-1.

    PMID: 8771319BACKGROUND
  • Madsen MR, Jensen KE. Postoperative pain and nausea after laparoscopic cholecystectomy. Surg Laparosc Endosc. 1992 Dec;2(4):303-5.

    PMID: 1341550BACKGROUND
  • Dobbs FF, Kumar V, Alexander JI, Hull MG. Pain after laparoscopy related to posture and ring versus clip sterilization. Br J Obstet Gynaecol. 1987 Mar;94(3):262-6. doi: 10.1111/j.1471-0528.1987.tb02365.x.

    PMID: 2952160BACKGROUND
  • Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.

    PMID: 8694166BACKGROUND
  • Kandil TS, El Hefnawy E. Shoulder pain following laparoscopic cholecystectomy: factors affecting the incidence and severity. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):677-82. doi: 10.1089/lap.2010.0112.

    PMID: 20701547BACKGROUND
  • 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: 28643053BACKGROUND
  • 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: 34248341BACKGROUND

Related Links

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Results about the effect of hot application on pain and analgesic use will be shared. however, personal information will not be shared.

Locations