Resting Visual Analog Scale (VAS) Pain ScorePhase 4NCT07795203
Liposomal Bupivacaine vs Ropivacaine for Post-hemorrhoidectomy Analgesia
A Phase 4 study testing Liposomal Bupivacaine (EXPAREL®)/Bupivacaine and Ropivacaine Hydrochloride in people with Resting Visual Analog Scale (VAS) Pain Score, run by Tongliao City People's Hospital at 1 site in China.
Trial summary
This is a single-center, prospective, randomized, double-blind controlled trial comparing the analgesic efficacy, quality of recovery, and safety of perianal wound infiltration with multivesicular liposomal bupivacaine (266 mg) versus ropivacaine hydrochloride (200 mg) in patients undergoing Milligan-Morgan open… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Resting Visual Analog Scale (VAS) Pain Score
- What is being tested?
- Liposomal Bupivacaine (EXPAREL®)/Bupivacaine and Ropivacaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Aged 18-60 years, irrespective of sex 2. Diagnosed with grade III-IV internal hemorrhoids or mixed hemorrhoids based on specialist examination and scheduled to undergo elective Milligan-Morgan open hemorrhoidectomy 3. American Society of Anesthesiologists (ASA) physical status I-III 4. Body mass index (BMI) of 18.0-30.0 kg/m² 5. Able to understand and complete the pain and quality-of-recovery assessments and willing to participate in the study
Who cannot join
- 1. Concomitant chronic low back or leg pain, anal fissure, perianal abscess, or other persistent painful conditions 2. Pregnancy, breastfeeding, or plans to become pregnant in the near future 3. Known allergy to bupivacaine, ropivacaine, or any other medication used during the study 4. Long-term regular use of opioids or use of analgesic medications within 48 hours before surgery 5. Obstructive sleep apnea syndrome or severe cardiovascular, cerebrovascular, or pulmonary disease considered to significantly increase risks associated with neuraxial anesthesia or postoperative analgesia 6. Psychiatric or cognitive impairment that precludes completion of study assessments 7. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongliao People's Hospital
Neimeng, Tongliao, 028000
Bo Sun, 0475-82511603, tlsyybgs@163.com
About this study
Official title: Liposomal Bupivacaine Versus Ropivacaine for Wound Infiltration Analgesia After Milligan-Morgan Open Hemorrhoidectomy: A Randomized Controlled Trial
This is a single-center, prospective, randomized, double-blind controlled trial comparing the analgesic efficacy, quality of recovery, and safety of perianal wound infiltration with multivesicular liposomal bupivacaine (266 mg) versus ropivacaine hydrochloride (200 mg) in patients undergoing Milligan-Morgan open hemorrhoidectomy under spinal anesthesia. Both solutions are diluted to a total volume of 30 mL and infiltrated at six predefined perianal positions at the end of surgery. The primary outcome is the resting visual analog scale (VAS) pain score at 24 hours after surgery. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative rescue analgesic consumption during postoperative days 1-3, Quality of Recovery-40 (QoR-40) scores on postoperative days 1-3, and adverse events within 72 hours after surgery.
Read the detailed description
Milligan-Morgan open hemorrhoidectomy is associated with substantial postoperative pain due to rich somatic innervation of the perianal region, wound exposure, anal sphincter spasm, and stimulation during defecation. Optimizing postoperative analgesia is critical for enhanced recovery. Local wound infiltration with ropivacaine is commonly used but provides limited duration of analgesia. Liposomal bupivacaine, formulated with a multivesicular liposomal delivery system, enables sustained release of bupivacaine at the injection site and may prolong local analgesia. However, high-quality comparative evidence between liposomal bupivacaine and ropivacaine for wound infiltration after open hemorrhoidectomy remains limited.
This single-center, prospective, randomized, double-blind controlled trial enrolled patients aged 18-60 years with grade III-IV internal hemorrhoids or mixed hemorrhoids scheduled for elective Milligan-Morgan open hemorrhoidectomy at Tongliao People's Hospital between November 2025 and May 2026. Patients were randomized 1:1 to receive perianal wound infiltration with either 266 mg of liposomal bupivacaine or 200 mg of ropivacaine hydrochloride, both diluted to 30 mL with normal saline and divided into six 5-mL aliquots infiltrated at six predefined perianal clock-face positions. All patients received spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Rescue analgesia with oral diclofenac sodium 50 mg was provided when VAS pain score was ≥4.
The primary outcome is resting VAS pain score at 24 hours postoperatively. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative diclofenac sodium consumption during postoperative days 1-3, QoR-40 total scores on postoperative days 1-3, and adverse events (nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, surgical-site infection) within 72 hours.
- Being tested
- Liposomal Bupivacaine (EXPAREL®)/Bupivacaine, Ropivacaine Hydrochloride
- Keywords
- Resting and movement-evoked VAS pain scores；Cumulative rescue analgesic consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine (EXPAREL®)/BupivacaineDrug
266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
Ropivacaine HydrochlorideDrug
200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Patients receive perianal wound infiltration with 266 mg of multivesicular liposomal bupivacaine (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery. Receives: Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine |
| Ropivacaine Group | Active comparator | Patients receive perianal wound infiltration with 200 mg of ropivacaine hydrochloride (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery. Receives: Drug: Ropivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting visual analog scale (VAS) pain score
Pain intensity at rest assessed using a 10-cm VAS, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Measured: 48 hours after surgery
Secondary outcomes (4)
Resting and movement-evoked VAS pain scores
Pain intensity at rest and during movement assessed using a 10-cm VAS at predefined postoperative time points.
Measured: 4, 6, 12, 24, and 48 hours after surgery
Cumulative rescue analgesic consumption
Cumulative dose of oral diclofenac sodium (mg) consumed as rescue analgesia when VAS pain score ≥4. Maximum daily dose 150 mg, minimum interval 8 hours
Measured: Postoperative days 1-3 (within 72 hours)
Quality of Recovery-40 (QoR-40) total score
The QoR-40 comprises 40 items across five dimensions (physical comfort, emotional state, physical independence, psychological support, and pain). Total scores range from 40 to 200, with higher scores indicating better postoperative recovery.
Measured: Postoperative days 1, 2, and 3
Incidence of adverse events
Adverse events including nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, and surgical-site infection
Measured: Within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resting Visual Analog Scale (VAS) Pain ScoreStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongliao City People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Xiaona, Tongliao City People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795203
- Sponsor's protocol ID
- TongliaoCPH
- Other IDs
- 337087
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during this study are available from the corresponding author upon reasonable request by email.
Publications
Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
PubMed 22067185
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine Versus Ropivacaine for Wound Infiltration Analgesia After Milligan-Morgan Open Hemorrhoidectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07795203
- Acronym / sponsor ID
- TongliaoCPH
- Keywords
- Resting and movement-evoked VAS pain scores；Cumulative rescue analgesic consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tongliao City People's HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 31 Aug 2026 (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.
This is a single-center, prospective, randomized, double-blind controlled trial comparing the analgesic efficacy, quality of recovery, and safety of perianal wound infiltration with multivesicular liposomal bupivacaine (266 mg) versus ropivacaine hydrochloride (200 mg) in patients undergoing Milligan-Morgan open hemorrhoidectomy under spinal anesthesia. Both solutions are diluted to a total volume of 30 mL and infiltrated at six predefined perianal positions at the end of surgery. The primary outcome is the resting visual analog scale (VAS) pain score at 24 hours after surgery. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative rescue analgesic consumption during postoperative days 1-3, Quality of Recovery-40 (QoR-40) scores on postoperative days 1-3, and adverse events within 72 hours after surgery.
Detailed description
Milligan-Morgan open hemorrhoidectomy is associated with substantial postoperative pain due to rich somatic innervation of the perianal region, wound exposure, anal sphincter spasm, and stimulation during defecation. Optimizing postoperative analgesia is critical for enhanced recovery. Local wound infiltration with ropivacaine is commonly used but provides limited duration of analgesia. Liposomal bupivacaine, formulated with a multivesicular liposomal delivery system, enables sustained release of bupivacaine at the injection site and may prolong local analgesia. However, high-quality comparative evidence between liposomal bupivacaine and ropivacaine for wound infiltration after open hemorrhoidectomy remains limited.
This single-center, prospective, randomized, double-blind controlled trial enrolled patients aged 18-60 years with grade III-IV internal hemorrhoids or mixed hemorrhoids scheduled for elective Milligan-Morgan open hemorrhoidectomy at Tongliao People's Hospital between November 2025 and May 2026. Patients were randomized 1:1 to receive perianal wound infiltration with either 266 mg of liposomal bupivacaine or 200 mg of ropivacaine hydrochloride, both diluted to 30 mL with normal saline and divided into six 5-mL aliquots infiltrated at six predefined perianal clock-face positions. All patients received spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Rescue analgesia with oral diclofenac sodium 50 mg was provided when VAS pain score was ≥4.
The primary outcome is resting VAS pain score at 24 hours postoperatively. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative diclofenac sodium consumption during postoperative days 1-3, QoR-40 total scores on postoperative days 1-3, and adverse events (nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, surgical-site infection) within 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Drug: Liposomal Bupivacaine (EXPAREL®)/BupivacainePatients receive perianal wound infiltration with 266 mg of multivesicular liposomal bupivacaine (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery. |
| Ropivacaine Group | Active comparator | Drug: Ropivacaine HydrochloridePatients receive perianal wound infiltration with 200 mg of ropivacaine hydrochloride (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Aged 18-60 years, irrespective of sex 2. Diagnosed with grade III-IV internal hemorrhoids or mixed hemorrhoids based on specialist examination and scheduled to undergo elective Milligan-Morgan open hemorrhoidectomy 3. American Society of Anesthesiologists (ASA) physical status I-III 4. Body mass index (BMI) of 18.0-30.0 kg/m² 5. Able to understand and complete the pain and quality-of-recovery assessments and willing to participate in the study
Key exclusion criteria (2 listed)
- 1. Concomitant chronic low back or leg pain, anal fissure, perianal abscess, or other persistent painful conditions 2. Pregnancy, breastfeeding, or plans to become pregnant in the near future 3. Known allergy to bupivacaine, ropivacaine, or any other medication used during the study 4. Long-term regular use of opioids or use of analgesic medications within 48 hours before surgery 5. Obstructive sleep apnea syndrome or severe cardiovascular, cerebrovascular, or pulmonary disease considered to significantly increase risks associated with neuraxial anesthesia or postoperative analgesia 6. Psychiatric or cognitive impairment that precludes completion of study assessments 7. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation
- -
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 |
|---|---|---|
| Liposomal Bupivacaine (EXPAREL®)/Bupivacaine266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery | Drug | Liposomal Bupivacaine Group |
| Ropivacaine Hydrochloride200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery | Drug | Ropivacaine Group |
Primary outcome
Resting visual analog scale (VAS) pain score
Time frame: 48 hours after surgery
Pain intensity at rest assessed using a 10-cm VAS, with 0 indicating no pain and 10 indicating the worst imaginable pain.
4 secondary outcomes
Resting and movement-evoked VAS pain scores
Time frame: 4, 6, 12, 24, and 48 hours after surgery
Cumulative rescue analgesic consumption
Time frame: Postoperative days 1-3 (within 72 hours)
Quality of Recovery-40 (QoR-40) total score
Time frame: Postoperative days 1, 2, and 3
Incidence of adverse events
Time frame: Within 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 22067185Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
- Individual participant dataSharing planned: Yes. The datasets generated during this study are available from the corresponding author upon reasonable request by email.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Bupivacaine (EXPAREL®)/Bupivacaine and Ropivacaine Hydrochloride in people with Resting Visual Analog Scale (VAS) Pain Score, run by Tongliao City People's Hospital at 1 site in China.
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: opening soon, as of the sponsor's last update on 31 Aug 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaona Liu (+8615894886794, 15894886794@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting visual analog scale (VAS) pain score (time frame: 48 hours after surgery). 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 NCT07795203, which also lists 1 linked publication.
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 31 Aug 2026.