Pain, ShoulderNCT05334797
The Effect of Hot Application on Post Laparoscopic Shoulder Pain and Analgesic Use
A study testing Local heat therapy in people with Pain, Shoulder, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Shoulder
- What is being tested?
- Local heat therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2022to 19 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Undergoing emergency surgery. Cognitive impairment preventing reliable pain self-report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hot Application on Shoulder Pain and Analgesic Use After Laparoscopic Upper Abdominal Surgery
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.
Read the 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).
- Conditions
- Pain, Shoulder
- Being tested
- Local heat therapy
- Keywords
- postlaparoscopic, shoulder pain, analgesic, Hot application
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local heat therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start12 Apr 2022
- Primary completion12 Apr 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pain, ShoulderStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Gezer, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334797
- Sponsor's protocol ID
- PLSP
- Status last verified
- Aug 2024
- First submitted
- 9 Apr 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results about the effect of hot application on pain and analgesic use will be shared. however, personal information will not be shared.
Publications
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.
PubMed 1826624Valla 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.
PubMed 1669397Nieboer 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.
PubMed 19588344Gerbershagen 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.
PubMed 23392233Mouton WG, Bessell JR, Otten KT, Maddern GJ. Pain after laparoscopy. Surg Endosc. 1999 May;13(5):445-8. doi: 10.1007/s004649901011.
PubMed 10227938Fredman 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.
PubMed 8010427Cason 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.
PubMed 8771319Madsen MR, Jensen KE. Postoperative pain and nausea after laparoscopic cholecystectomy. Surg Laparosc Endosc. 1992 Dec;2(4):303-5.
PubMed 1341550Dobbs 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.
PubMed 2952160Jackson 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.
PubMed 8694166Kandil 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.
PubMed 20701547Lee 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.
PubMed 28643053Li 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.
PubMed 34248341
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Application on Shoulder Pain and Analgesic Use After Laparoscopic Upper Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05334797
- Acronym / sponsor ID
- PLSP
- Conditions
- Pain, Shoulder
- Keywords
- postlaparoscopic, shoulder pain, analgesic, Hot application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot application | Experimental | Other: Local heat therapyParticipants 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Undergoing emergency surgery. Cognitive impairment preventing reliable pain self-report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local heat therapyA 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. | Other | Hot application |
Primary outcome
change of pain
Time frame: During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).
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.
analgesic consumption
Time frame: During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 1826624Grace 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.
- Background: PubMed 1669397Valla 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.
- Background: PubMed 19588344Nieboer 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.
- Background: PubMed 23392233Gerbershagen 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.
- Background: PubMed 10227938Mouton WG, Bessell JR, Otten KT, Maddern GJ. Pain after laparoscopy. Surg Endosc. 1999 May;13(5):445-8. doi: 10.1007/s004649901011.
- Background: PubMed 8010427Fredman 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.
- Background: PubMed 8771319Cason 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.
- Background: PubMed 1341550Madsen MR, Jensen KE. Postoperative pain and nausea after laparoscopic cholecystectomy. Surg Laparosc Endosc. 1992 Dec;2(4):303-5.
- Background: PubMed 2952160Dobbs 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.
- Background: PubMed 8694166Jackson 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.
- Background: PubMed 20701547Kandil 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.
- Background: PubMed 28643053Lee 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.
- Heating pads and early mobilization for reducing postoperative shoulder pain and enhancing recovery of women undergoing gynecological laparoscopic surgeryLink provided by the sponsor.
- Ağrı kontrolünde farmakolojik olmayan yöntemlerLink provided by the sponsor.
- Individual participant dataSharing planned: No. Results about the effect of hot application on pain and analgesic use will be shared. however, personal information will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local heat therapy in people with Pain, Shoulder, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pain (time frame: During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334797, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.