Post-surgical PainPhase 4HHEPANCT06823180
Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section
A Phase 4 study testing Hydromorphone hydrochloride low dose, Hydromorphone hydrochloride high dose and 0.9% sodium chloride in people with Post-surgical Pain, run by Liquan Liang at 1 site in China.
Trial summary
Acute pain often occurs after cesarean section, which can lead to stress and inflammatory response in the body, which will not only affect the postpartum recovery speed of the puerpera, but also inhibit the secretion of prolactin to a certain extent and reduce the secretion of milk. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Post-surgical Pain
- What is being tested?
- Hydromorphone hydrochloride low dose, Hydromorphone hydrochloride high dose and 0.9% sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2025to 28 Aug 2025
- Phase
- Phase 4
- 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 22 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturients with indications for cesarean section;
- American Association of Anesthesiologists (ASA) Grade I - II;
- No history of sedative drugs or opioid abuse;
- Volunteer to join the study
Who cannot join
- People with coagulation disorders;
- preoperative use of analgesia, non-steroidal drugs;
- Abnormal liver and kidney function;
- Postoperative drainage is urgently needed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effect of Hydromorphone Hydrochloride Epidural Preemptive Analgesia on Postoperative Pain After Cesarean Section
Acute pain often occurs after cesarean section, which can lead to stress and inflammatory response in the body, which will not only affect the postpartum recovery speed of the puerpera, but also inhibit the secretion of prolactin to a certain extent and reduce the secretion of milk. Epidural anesthesia is a common anesthesia method for cesarean section, which has the advantages of easy operation and little influence on the fetus. Preemptive analgesia can effectively block the transmission of harmful stimuli and reduce the degree of pain after cesarean section. Hydromorphone hydrochloride is a derivative of morphine, which has the advantages of rapid onset and good analgesic effect, and has been widely used in clinic. However, it is not clear whether epidural injection of hydromorphone hydrochloride for preanalgesia can bring clinical benefits to puerpera, and the optimal dose of hydromorphone hydrochloride for cesarean section is also unclear.
The parturient women who met the inclusion criteria were randomly divided into 3 groups: control group, hydromorphone hydrochloride low-dose administration group and hydromorphone hydrochloride high-dose administration group. All women received epidural combined subarachnoid anesthesia. 15min before the end of the operation, the low-dose hydromorphone hydrochloride group was injected with 0.1mg hydromorphone hydrochloride in the epidural space, the high-dose hydromorphone hydrochloride group was injected with 0.3mg hydromorphone hydrochloride in the epidural space, and the control group was injected with 0.9% sodium chloride injection. Post-obstetric visual analogue scale (VAS) was followed up to record PCA compression times, gastrointestinal peristalsis recovery time, getting out of bed time, lactation time, and related adverse reactions.
- Conditions
- Post-surgical Pain
- Being tested
- Hydromorphone hydrochloride low dose, Hydromorphone hydrochloride high dose, 0.9% sodium chloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone hydrochloride low doseDrug
15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected into the epidural space in the low-dose group for preemptive analgesia.
Hydromorphone hydrochloride high doseDrug
15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected into the epidural space in the high-dose group for preemptive analgesia.
0.9% sodium chlorideDrug
15min before the end of the operation, 0.9% sodium chloride injection was given in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Low dose of hydromorphone hydrochloride was given to the drug group | Experimental | 15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected epidural into the low-dose group for preemptive analgesia. Receives: Drug: Hydromorphone hydrochloride low dose |
| High dose of hydromorphone hydrochloride was given to the drug group | Experimental | 15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected epidural into the high dose group for preemptive analgesia. Receives: Drug: Hydromorphone hydrochloride high dose |
| control group | Placebo comparator | 15min before the end of the operation, the control group was simply given equal dose 0.9% sodium chloride injection. Receives: Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
VAS score was used to evaluate the pain in each period after obstetric surgery. A strip marked with a scale of 0-10 was taken, where 0 indicated no pain, the pain degree increased with the increase of the score, and 10 indicated the most pain. The mothers chose the score matching their own pain degree. Mild pain: 0<VAS<4 ; Moderate pain :4 ≤VAS< 7; Severe pain :7 ≤VAS<9; Extreme pain: VAS≥9.
Measured: 24 hours after surgery
Secondary outcomes (7)
The number of PCA compressions after surgery
Measured: 48 hours after surgery
Satisfaction evaluation
Patients' satisfaction was assessed by HCAHPS survey. The survey was designed to assess patient inpatient experience, including nurse care, physician communication, hospital environment, hospital experience, discharge information provision, and overall hospital evaluation.
Measured: Before discharge
Gastrointestinal peristalsis recovery time
The recovery time of bowel sound, anal exhaust and defecation were recorded.
Measured: 72 hours after surgery
The time it takes to get out of bed for the first time after surgery
Measured: 96 hours after surgery
The time between the end of surgery and lactation
Measured: 72 hours after surgery
Postoperative nausea and vomiting（PONV）
PONV rating standards of WHO are adopted. Specifically: Grade I is no nausea, vomiting; Grade II was mild nausea, abdominal discomfort, but no vomiting; Grade III is nausea and vomiting, but there is no content spit out; Grade IV is severe vomiting, with vomiting of stomach contents and requiring medical control.
Measured: 72 hours after surgery
pruritus
The numeric rating scale (NRS) was used to evaluate the degree of postoperative pruritus. Itching is numerically graded on the NRS scale, with 0 indicating no itching and 10 indicating the most severe itching. The degree of itching increased with the increase of the score. Mild pruritus :0<NRS<4 ; Moderate pruritus :4 ≤NRS< 7; Severe pruritus :7 ≤NRS<9; Extreme pruritus :NRS≥9.
Measured: 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 posted12 Feb 2025
- Study start3 Mar 2025
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgical PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquan Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liquan Liang, Jiangxi Provincial People's Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823180
- Sponsor's protocol ID
- 2024-128IITFS
- Acronym
- HHEPA
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Hydromorphone Hydrochloride Epidural Preemptive Analgesia on Postoperative Pain After Cesarean Section
- ClinicalTrials.gov ID
- NCT06823180
- Acronym / sponsor ID
- HHEPA / 2024-128IITFS
- Conditions
- Post-surgical Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Liquan LiangUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 12 Feb 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.
Acute pain often occurs after cesarean section, which can lead to stress and inflammatory response in the body, which will not only affect the postpartum recovery speed of the puerpera, but also inhibit the secretion of prolactin to a certain extent and reduce the secretion of milk. Epidural anesthesia is a common anesthesia method for cesarean section, which has the advantages of easy operation and little influence on the fetus. Preemptive analgesia can effectively block the transmission of harmful stimuli and reduce the degree of pain after cesarean section. Hydromorphone hydrochloride is a derivative of morphine, which has the advantages of rapid onset and good analgesic effect, and has been widely used in clinic. However, it is not clear whether epidural injection of hydromorphone hydrochloride for preanalgesia can bring clinical benefits to puerpera, and the optimal dose of hydromorphone hydrochloride for cesarean section is also unclear.
The parturient women who met the inclusion criteria were randomly divided into 3 groups: control group, hydromorphone hydrochloride low-dose administration group and hydromorphone hydrochloride high-dose administration group. All women received epidural combined subarachnoid anesthesia. 15min before the end of the operation, the low-dose hydromorphone hydrochloride group was injected with 0.1mg hydromorphone hydrochloride in the epidural space, the high-dose hydromorphone hydrochloride group was injected with 0.3mg hydromorphone hydrochloride in the epidural space, and the control group was injected with 0.9% sodium chloride injection. Post-obstetric visual analogue scale (VAS) was followed up to record PCA compression times, gastrointestinal peristalsis recovery time, getting out of bed time, lactation time, and related adverse reactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose of hydromorphone hydrochloride was given to the drug group | Experimental | Drug: Hydromorphone hydrochloride low dose15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected epidural into the low-dose group for preemptive analgesia. |
| High dose of hydromorphone hydrochloride was given to the drug group | Experimental | Drug: Hydromorphone hydrochloride high dose15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected epidural into the high dose group for preemptive analgesia. |
| control group | Placebo comparator | Drug: 0.9% sodium chloride15min before the end of the operation, the control group was simply given equal dose 0.9% sodium chloride injection. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parturients with indications for cesarean section;
- American Association of Anesthesiologists (ASA) Grade I - II;
- No history of sedative drugs or opioid abuse;
- Volunteer to join the study
Key exclusion criteria (4 listed)
- People with coagulation disorders;
- preoperative use of analgesia, non-steroidal drugs;
- Abnormal liver and kidney function;
- Postoperative drainage is urgently needed.
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 |
|---|---|---|
| Hydromorphone hydrochloride low dose15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected into the epidural space in the low-dose group for preemptive analgesia. | Drug | Low dose of hydromorphone hydrochloride was given to the drug group |
| Hydromorphone hydrochloride high dose15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected into the epidural space in the high-dose group for preemptive analgesia. | Drug | High dose of hydromorphone hydrochloride was given to the drug group |
| 0.9% sodium chloride15min before the end of the operation, 0.9% sodium chloride injection was given in the control group. | Drug | control group |
Primary outcome
VAS score
Time frame: 24 hours after surgery
VAS score was used to evaluate the pain in each period after obstetric surgery. A strip marked with a scale of 0-10 was taken, where 0 indicated no pain, the pain degree increased with the increase of the score, and 10 indicated the most pain. The mothers chose the score matching their own pain degree. Mild pain: 0<VAS<4 ; Moderate pain :4 ≤VAS< 7; Severe pain :7 ≤VAS<9; Extreme pain: VAS≥9.
7 secondary outcomes
The number of PCA compressions after surgery
Time frame: 48 hours after surgery
Satisfaction evaluation
Time frame: Before discharge
Gastrointestinal peristalsis recovery time
Time frame: 72 hours after surgery
The time it takes to get out of bed for the first time after surgery
Time frame: 96 hours after surgery
The time between the end of surgery and lactation
Time frame: 72 hours after surgery
Postoperative nausea and vomiting（PONV）
Time frame: 72 hours after surgery
pruritus
Time frame: 72 hours after surgery
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 5 Sep 2025.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Hydromorphone hydrochloride low dose, Hydromorphone hydrochloride high dose and 0.9% sodium chloride in people with Post-surgical Pain, run by Liquan Liang 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 4 inclusion and 4 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 5 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 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. Some participants in this study may receive a placebo. 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?
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?
VAS score (time frame: 24 hours after surgery). 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 5 Sep 2025.