Low-Dose Epidural Hydromorphone as an Adjunct to Ropivacaine for Intraoperative Visceral Traction Pain During Elective Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial.
- 1Department of Anesthesiology, Chongqing Wanzhou Health Center for Women and Children, Chongqing, People's Republic of China.
Abstract
Purpose
Visceral traction during cesarean delivery may cause pain, nausea, and autonomic activation despite an adequate neuraxial block. We evaluated whether adding 0.3 mg epidural hydromorphone to ropivacaine altered patient-reported pain and clinically relevant traction responses across predefined perioperative phases.Patients and methods
In this single-center, double-blind, placebo-controlled trial, 96 women undergoing elective cesarean delivery were randomized 1:1 to epidural hydromorphone or saline. The registered primary outcome domains were visual analog scale (VAS) pain score and heart rate variability (HRV) across five time points. Other prespecified clinical measures included clinician-rated traction response, maternal adverse events, and neonatal outcomes. The protocol-specified repeated-measures analysis was used for longitudinal pain; abdominal exploration (T2) was selected after registration as the focal phase for detailed reporting.Results
All 96 women completed the trial. The longitudinal pain analysis showed a group-by-time interaction (Greenhouse-Geisser corrected p=0.008; participant-level randomization-based permutation p=0.009). At the post-registration focal comparison during abdominal exploration, median (IQR) VAS was 1.65 (0.70-2.60) with hydromorphone and 1.90 (0.78-3.92) with saline (nominal Mann-Whitney p=0.039). Clinician-rated traction grade favored hydromorphone (trend p=0.003). Nausea or vomiting occurred in 3/48 (6.2%) versus 12/48 (25.0%) women (risk ratio 0.25, 95% CI 0.08-0.83; p=0.022). For the registered HRV domain, the interaction for ln(LF/HF), selected after registration as the principal reported metric, was not significant (p=0.442). No maternal respiratory depression occurred, and neonatal outcomes showed no material between-group differences.Conclusion
Low-dose epidural hydromorphone added to ropivacaine was associated with a different longitudinal pain profile and fewer episodes of intraoperative nausea or vomiting during elective cesarean delivery. Post hoc pain-distribution and exploratory physiological findings require prospective confirmation.Trial registration
Chinese Clinical Trial Registry, ChiCTR2400094749; registered December 26, 2024, before enrollment.
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BibTeX
@article{zhang2026lowdose,
title = {{Low-Dose Epidural Hydromorphone as an Adjunct to Ropivacaine for Intraoperative Visceral Traction Pain During Elective Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial.}},
author = {Yi Zhang and Qingjun Zeng and Haishan Cui and Chunmei Li},
journal = {Drug design, development and therapy},
year = {2026},
month = oct,
doi = {10.2147/dddt.s649481},
url = {https://europepmc.org/article/MED/42948659},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Low-Dose Epidural Hydromorphone as an Adjunct to Ropivacaine for Intraoperative Visceral Traction Pain During Elective Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial.
AU - Yi Zhang
AU - Qingjun Zeng
AU - Haishan Cui
AU - Chunmei Li
PY - 2026
DA - 2026/10/23
JO - Drug design, development and therapy
DO - 10.2147/dddt.s649481
UR - https://europepmc.org/article/MED/42948659
AB - Purpose Visceral traction during cesarean delivery may cause pain, nausea, and autonomic activation despite an adequate neuraxial block. We evaluated whether adding 0.3 mg epidural hydromorphone to ropivacaine altered patient-reported pain and clinically relevant traction responses across predefined perioperative phases.Patients and methods In this single-center, double-blind, placebo-controlled trial, 96 women undergoing elective cesarean delivery were randomized 1:1 to epidural hydromorphone or saline. The registered primary outcome domains were visual analog scale (VAS) pain score and heart rate variability (HRV) across five time points. Other prespecified clinical measures included clinician-rated traction response, maternal adverse events, and neonatal outcomes. The protocol-specified repeated-measures analysis was used for longitudinal pain; abdominal exploration (T2) was selected after registration as the focal phase for detailed reporting.Results All 96 women completed the trial. The longitudinal pain analysis showed a group-by-time interaction (Greenhouse-Geisser corrected p=0.008; participant-level randomization-based permutation p=0.009). At the post-registration focal comparison during abdominal exploration, median (IQR) VAS was 1.65 (0.70-2.60) with hydromorphone and 1.90 (0.78-3.92) with saline (nominal Mann-Whitney p=0.039). Clinician-rated traction grade favored hydromorphone (trend p=0.003). Nausea or vomiting occurred in 3/48 (6.2%) versus 12/48 (25.0%) women (risk ratio 0.25, 95% CI 0.08-0.83; p=0.022). For the registered HRV domain, the interaction for ln(LF/HF), selected after registration as the principal reported metric, was not significant (p=0.442). No maternal respiratory depression occurred, and neonatal outcomes showed no material between-group differences.Conclusion Low-dose epidural hydromorphone added to ropivacaine was associated with a different longitudinal pain profile and fewer episodes of intraoperative nausea or vomiting during elective cesarean delivery. Post hoc pain-distribution and exploratory physiological findings require prospective confirmation.Trial registration Chinese Clinical Trial Registry, ChiCTR2400094749; registered December 26, 2024, before enrollment.
SN - 1177-8881
ER -