Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330038, China
NCT Number: NCT06823180
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.
Looking for future studies?
Notify Me22 year–45 year
Female
Interventional
Phase 4
Nanchang, Jiangxi, 330038, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
15min before the end of the operation, 0.9% sodium chloride injection was given in the control group.
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.
Time frame: 48 hours after surgery
Time frame: Before discharge
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.
Time frame: 72 hours after surgery
The recovery time of bowel sound, anal exhaust and defecation were recorded.
Time frame: 96 hours after surgery
Time frame: 72 hours after surgery
Time frame: 72 hours after surgery
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.
Time frame: 72 hours after surgery
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.
Liquan Liang
Other
Clinical Effect of Hydromorphone Hydrochloride Epidural Preemptive Analgesia on Postoperative Pain After Cesarean Section
Acronym: HHEPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06455345
Acute Pain, Chronic Pain
Toronto, Ontario, Canada
View Trial DetailsNCT04988490
Cancer, Cannabis Use
Denver, Colorado, United States
View Trial DetailsNCT03933124
Agnosia, Nervous System Diseases
Nijmegen, Netherlands
View Trial DetailsNCT03599089
Neurologic Manifestations, Pain
Pasadena, California, United States
View Trial Details