Postoperative PainICE-HEMONCT07186348
Efficacy of Ice Packing Application in Post-Hemorrhoidectomy Recovery
A study testing Ice packing in people with Postoperative Pain and Hemorrhoids Third Degree, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
According to the previous study, surgical intervention exhibited significant differences in daily life before and after a hemorrhoidectomy. However, post-hemorrhoidectomy pain remains a challenging problem, and the incidence of moderate to severe post-hemorrhoidectomy pain could be as high as 65%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree
- What is being tested?
- Ice packing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 12 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with grade III or IV hemorrhoids who underwent Ferguson hemorrhoidectomy
Who cannot join
- Patients who also underwent additional anorectal surgeries-such as fistulectomy, ulcerectomy, isolated external skin tag excision
- Patients with incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ice Packing Application in Post-Hemorrhoidectomy Recovery: A Propensity Score-Matched Study
According to the previous study, surgical intervention exhibited significant differences in daily life before and after a hemorrhoidectomy. However, post-hemorrhoidectomy pain remains a challenging problem, and the incidence of moderate to severe post-hemorrhoidectomy pain could be as high as 65%. In particular, post-hemorrhoidectomy pain management remains unsolved in 5% of cases who remains severe pain despite standard pain management which potentially leads to a longer hospital stay and more opioid requirement.
Post-hemorrhoidectomy pain arises from multiple pathological mechanisms. Tissue trauma during the surgical procedure activates nociceptors in the richly innervated anal region. The subsequent inflammatory response releases cytokines, leading to localized edema and increased nerve sensitivity. Anal sphincter spasm, a common postoperative response, further exacerbates pain by creating tension around the surgical site. Additionally, defecation can mechanically irritate the wound, particularly in cases of hard stools or straining, further aggravating discomfort.
Read more
The benefits of cold therapy have been recognized for thousands of years. By lowering tissue temperature through ice packing, it is believed that blood flow, pain, metabolism, and muscle spasms can be reduced, thereby minimizing inflammation and promoting the recovery of soft-tissue injuries. Ice therapy has been shown to be a safe and effective method for postoperative pain management in various procedures, including orthopedic surgery, maxillofacial surgery, laparotomy and laparoscopic surgery, thoracic surgery, hernia repair, and gynecologic of postpartum care.
Our study hypothesized that the postoperative ice packing application in hemorrhoidectomy patients could help to manage post-hemorrhoidectomy pain, leading to either reduced narcotic consumption or improved pain control compared to patients who did not use ice packing application, and while ensuring patients' safety during the surgical intervention. The study aimed to assess the effectiveness of ice packing application versus the standard of care in relieving pain following hemorrhoidectomies.
Read the detailed description
Data were collected from patients diagnosed with grade III or IV hemorrhoids who underwent surgical intervention between January 2021 and September 2022 at the Keelung branch of Chang Gung Memorial Hospital, Taiwan. Clinical demographic data, medication history, hemorrhoid-related characteristics, operative details, postoperative pain scores, and outcomes were retrieved from the hospital's electronic medical records. Patient demographics and medication histories-including age, gender, American Society of Anesthesiologists (ASA) classification, Eastern Cooperative Oncology Group (ECOG) performance status, body mass index (BMI), tobacco use, and comorbidities-were recorded. Hemorrhoid-related characteristics, such as symptoms, disease grading, and the number of hemorrhoidectomy quadrants, were also documented. Operative characteristics and postoperative outcomes were recorded, including length of hospital stay, number of outpatient department (OPD) visits, operative time and surgical devices used, complications, painkiller usage, and postoperative Numeric Rating Scale (NRS) pain score. Postoperative complications included acute urinary retention (AUR), bleeding, stool impaction, prolonged hospital stay, and readmission rates were also recorded. All patients were followed until September 2023 or until follow-up visits were no longer required. The median follow-up period was 2 months. All data collection and analysis procedures were approved by the Institutional Review Board of Chang Gung Memorial Hospital, Taiwan (IRB No. 202301650B0).
This retrospective cohort study initially included 480 consecutive patients with grade III or IV hemorrhoids who underwent surgical intervention. Patients who also underwent additional anorectal surgeries-such as fistulectomy (n=16), ulcerectomy (n=14), isolated external skin tag excision (n=3)-or had incomplete data (n=18) were excluded, leaving 429 patients eligible for inclusion. Ice packing was introduced and application starting in August 2021. Based on the surgery date, patients were divided into two groups: the standard care group (before August 2021) and the ice packing group (after August 2021). To address selection bias inherent to this non-randomized study and achieve balanced covariates across the groups, propensity score matching (PSM) was performed using a logistic regression model, with the use of ice packing as the dependent variable. Patients in both groups were matched based on clinical characteristics, including sex, age, ASA, BMI, smoking status, comorbidities, disease grading, number of hemorrhoidectomy quadrants, surgical device, and postoperative pain management. A 1:1 PSM was conducted using the nearest neighbor matching method with a caliper width of 0.2.
All patients underwent standard preoperative preparation and pre-anesthesia evaluation. Surgical procedures were performed by five experienced surgeons, with the operation's extent determined by hemorrhoid grading. LigaSure™, a single-use, self-funded energy device, was used with patient consent. Patients taking anticoagulants (e.g., Clopidogrel, apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin) were instructed to discontinue their medications 5 to 7 days before surgery and resume them 24 to 48 hours post-surgery. Antiplatelet agents, such as aspirin, were continued during the perioperative period.
The surgical procedure was as follows: patients were positioned in the Sims position under mask-induced general anesthesia. A digital examination and anoscopy were performed, followed by an injection of lidocaine and adrenaline (10,000:1) to provide additional local anesthesia and facilitate mucosal dissection. Hemorrhoid complexes requiring excision were clearly identified. The Ferguson procedure was then performed. For patients opting for LigaSure™-assisted hemorrhoidectomy, excision and dissection followed the same protocol using the device. After achieving adequate hemostasis, the apex of each hemorrhoid pedicle was suture-ligated, and the mucosal and skin wounds were closed with 4-0 Polysorb™ sutures. At the conclusion of the procedure, sebacoyl dinalbuphine ester (SDE), a single-dose, extended-release nalbuphine prodrug, was administered as self-funded analgesia with patient consent. In the ice packing group, a 10-minute ice packing application was performed postoperatively. The ice packing device, featuring a tissue fluid collection plastic test tube and condom, is illustrated in Figure 2, and Figure 3 illustrates the diagram utilized during the surgical procedure.
Post-surgery, intravenous fluids were discontinued upon waking from anesthesia. Patients were prescribed 1000 mg of mefenamic acid with 250 mg of magnesium oxide, taken four times daily. Sitz baths and wound care with neomycin ointment were performed twice daily as part of the routine postoperative care protocol. Morphine (5 mg) was administered via intramuscular injection every 6 hours if wound pain was intolerable. Additionally, parecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, was offered as self-funded analgesia via intravenous injection every 12 hours with patient consent. Patients were discharged on postoperative days 1 to 3 following smooth urination.
- Being tested
- Ice packing, Standard Care (in control arm)
- Keywords
- Ice packing, Cryotherapy, Hemorrhoidectomy, Postoperative pain, Acute urine retention
- Medical subject headings
- Pain, Postoperative, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice packingProcedure or surgery
Also called Cryotherapy
10 minutes ice packing application after surgery
Standard Care (in control arm)Procedure or surgery
Standard Care (in control arm)
| Study group | Role | What they receive |
|---|---|---|
| Ice packing Group | Active comparator | Ice packing with standard care Receives: Procedure: Ice packing; Procedure: Standard Care (in control arm) |
| Standard care group | Active comparator | Standard care Receives: Procedure: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain scores
NRS pain scores on the day of surgery and on the first postoperative day using Numeric Rating Scale(0 is equivalent to no pain and 10 indicates the worst possible pain)
Measured: From day of surgery till postoperative day 2, assessed up to 5 years
Secondary outcomes (4)
Acute urine retention
The sudden inability to void, usually associated with bloating, severe urgency, general distress, lower abdominal distension, and suprapubic pain
Measured: From day of surgery till postoperative day 2, assessed up to 5 years
Postoperative bleeding
Bleeding occurring after completion of a surgical procedure, which may occur immediately or may be delayed, and which may or may not be wound related
Measured: From day of surgery up to 1 month, assessed up to 5 years
Prolonged hospital stay
A hospital admission that lasts longer than what is considered typical or expected for a particular condition or procedure. In patients particularly post-hemorrhoidectomy, 3 days admission is expected.
Measured: From day of surgery up to day of discharge, assessed up to 5 years
Opioids consumption
Opioids consumption in administration frequency(n) and total doses(mg) needed for pain control post-hemorrhoidectomy
Measured: From day of surgery till day of discharge, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2021
- Primary completion30 Sep 2022
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186348
- Sponsor's protocol ID
- 202301650B0
- Acronym
- ICE-HEMO
- Status last verified
- May 2025
- First submitted
- 8 Jun 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ice Packing Application in Post-Hemorrhoidectomy Recovery: A Propensity Score-Matched Study
- ClinicalTrials.gov ID
- NCT07186348
- Acronym / sponsor ID
- ICE-HEMO / 202301650B0
- Keywords
- Ice packing, Cryotherapy, Hemorrhoidectomy, Postoperative pain, Acute urine retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 22 Sep 2025 (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.
According to the previous study, surgical intervention exhibited significant differences in daily life before and after a hemorrhoidectomy. However, post-hemorrhoidectomy pain remains a challenging problem, and the incidence of moderate to severe post-hemorrhoidectomy pain could be as high as 65%. In particular, post-hemorrhoidectomy pain management remains unsolved in 5% of cases who remains severe pain despite standard pain management which potentially leads to a longer hospital stay and more opioid requirement.
Post-hemorrhoidectomy pain arises from multiple pathological mechanisms. Tissue trauma during the surgical procedure activates nociceptors in the richly innervated anal region. The subsequent inflammatory response releases cytokines, leading to localized edema and increased nerve sensitivity. Anal sphincter spasm, a common postoperative response, further exacerbates pain by creating tension around the surgical site. Additionally, defecation can mechanically irritate the wound, particularly in cases of hard stools or straining, further aggravating discomfort.
The benefits of cold therapy have been recognized for thousands of years. By lowering tissue temperature through ice packing, it is believed that blood flow, pain, metabolism, and muscle spasms can be reduced, thereby minimizing inflammation and promoting the recovery of soft-tissue injuries. Ice therapy has been shown to be a safe and effective method for postoperative pain management in various procedures, including orthopedic surgery, maxillofacial surgery, laparotomy and laparoscopic surgery, thoracic surgery, hernia repair, and gynecologic of postpartum care.
Our study hypothesized that the postoperative ice packing application in hemorrhoidectomy patients could help to manage post-hemorrhoidectomy pain, leading to either reduced narcotic consumption or improved pain control compared to patients who did not use ice packing application, and while ensuring patients' safety during the surgical intervention. The study aimed to assess the effectiveness of ice packing application versus the standard of care in relieving pain following hemorrhoidectomies.
Detailed description
Data were collected from patients diagnosed with grade III or IV hemorrhoids who underwent surgical intervention between January 2021 and September 2022 at the Keelung branch of Chang Gung Memorial Hospital, Taiwan. Clinical demographic data, medication history, hemorrhoid-related characteristics, operative details, postoperative pain scores, and outcomes were retrieved from the hospital's electronic medical records. Patient demographics and medication histories-including age, gender, American Society of Anesthesiologists (ASA) classification, Eastern Cooperative Oncology Group (ECOG) performance status, body mass index (BMI), tobacco use, and comorbidities-were recorded. Hemorrhoid-related characteristics, such as symptoms, disease grading, and the number of hemorrhoidectomy quadrants, were also documented. Operative characteristics and postoperative outcomes were recorded, including length of hospital stay, number of outpatient department (OPD) visits, operative time and surgical devices used, complications, painkiller usage, and postoperative Numeric Rating Scale (NRS) pain score. Postoperative complications included acute urinary retention (AUR), bleeding, stool impaction, prolonged hospital stay, and readmission rates were also recorded. All patients were followed until September 2023 or until follow-up visits were no longer required. The median follow-up period was 2 months. All data collection and analysis procedures were approved by the Institutional Review Board of Chang Gung Memorial Hospital, Taiwan (IRB No. 202301650B0).
This retrospective cohort study initially included 480 consecutive patients with grade III or IV hemorrhoids who underwent surgical intervention. Patients who also underwent additional anorectal surgeries-such as fistulectomy (n=16), ulcerectomy (n=14), isolated external skin tag excision (n=3)-or had incomplete data (n=18) were excluded, leaving 429 patients eligible for inclusion. Ice packing was introduced and application starting in August 2021. Based on the surgery date, patients were divided into two groups: the standard care group (before August 2021) and the ice packing group (after August 2021). To address selection bias inherent to this non-randomized study and achieve balanced covariates across the groups, propensity score matching (PSM) was performed using a logistic regression model, with the use of ice packing as the dependent variable. Patients in both groups were matched based on clinical characteristics, including sex, age, ASA, BMI, smoking status, comorbidities, disease grading, number of hemorrhoidectomy quadrants, surgical device, and postoperative pain management. A 1:1 PSM was conducted using the nearest neighbor matching method with a caliper width of 0.2.
All patients underwent standard preoperative preparation and pre-anesthesia evaluation. Surgical procedures were performed by five experienced surgeons, with the operation's extent determined by hemorrhoid grading. LigaSure™, a single-use, self-funded energy device, was used with patient consent. Patients taking anticoagulants (e.g., Clopidogrel, apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin) were instructed to discontinue their medications 5 to 7 days before surgery and resume them 24 to 48 hours post-surgery. Antiplatelet agents, such as aspirin, were continued during the perioperative period.
The surgical procedure was as follows: patients were positioned in the Sims position under mask-induced general anesthesia. A digital examination and anoscopy were performed, followed by an injection of lidocaine and adrenaline (10,000:1) to provide additional local anesthesia and facilitate mucosal dissection. Hemorrhoid complexes requiring excision were clearly identified. The Ferguson procedure was then performed. For patients opting for LigaSure™-assisted hemorrhoidectomy, excision and dissection followed the same protocol using the device. After achieving adequate hemostasis, the apex of each hemorrhoid pedicle was suture-ligated, and the mucosal and skin wounds were closed with 4-0 Polysorb™ sutures. At the conclusion of the procedure, sebacoyl dinalbuphine ester (SDE), a single-dose, extended-release nalbuphine prodrug, was administered as self-funded analgesia with patient consent. In the ice packing group, a 10-minute ice packing application was performed postoperatively. The ice packing device, featuring a tissue fluid collection plastic test tube and condom, is illustrated in Figure 2, and Figure 3 illustrates the diagram utilized during the surgical procedure.
Post-surgery, intravenous fluids were discontinued upon waking from anesthesia. Patients were prescribed 1000 mg of mefenamic acid with 250 mg of magnesium oxide, taken four times daily. Sitz baths and wound care with neomycin ointment were performed twice daily as part of the routine postoperative care protocol. Morphine (5 mg) was administered via intramuscular injection every 6 hours if wound pain was intolerable. Additionally, parecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, was offered as self-funded analgesia via intravenous injection every 12 hours with patient consent. Patients were discharged on postoperative days 1 to 3 following smooth urination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice packing Group | Active comparator | Procedure: Ice packing, Procedure: Standard Care (in control arm)Ice packing with standard care |
| Standard care group | Active comparator | Procedure: Standard Care (in control arm)Standard care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with grade III or IV hemorrhoids who underwent Ferguson hemorrhoidectomy
Key exclusion criteria (2 listed)
- Patients who also underwent additional anorectal surgeries-such as fistulectomy, ulcerectomy, isolated external skin tag excision
- Patients with incomplete data
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 |
|---|---|---|
| Ice packingAlso: Cryotherapy10 minutes ice packing application after surgery | Procedure or surgery | Ice packing Group |
| Standard Care (in control arm)Standard Care (in control arm) | Procedure or surgery | Ice packing Group, Standard care group |
Primary outcome
NRS pain scores
Time frame: From day of surgery till postoperative day 2, assessed up to 5 years
NRS pain scores on the day of surgery and on the first postoperative day using Numeric Rating Scale(0 is equivalent to no pain and 10 indicates the worst possible pain)
4 secondary outcomes
Acute urine retention
Time frame: From day of surgery till postoperative day 2, assessed up to 5 years
Postoperative bleeding
Time frame: From day of surgery up to 1 month, assessed up to 5 years
Prolonged hospital stay
Time frame: From day of surgery up to day of discharge, assessed up to 5 years
Opioids consumption
Time frame: From day of surgery till day of discharge, assessed up to 5 years
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 22 Sep 2025.
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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 Ice packing in people with Postoperative Pain and Hemorrhoids Third Degree, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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 22 Sep 2025. 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 Taiwan. 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?
NRS pain scores (time frame: From day of surgery till postoperative day 2, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025.