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An Optimizing Multimodal Non-Opioids Perioperative Pain Control Protocol for the Patient Enhanced Recovery after Laparotomy Gynecological Surgery: A Randomized Controlled Trial

An Optimizing Multimodal Non-Opioids Perioperative Pain Control Protocol for the Patient Enhanced Recovery after Laparotomy Gynecological Surgery: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050703
Enrollment
Unknown
Registered
2021-09-02
Start date
2021-09-10
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gynecologic disease

Interventions

control group:The control group will receive standard preoperative and postoperative directions, with the anesthesiologist and surgeon's preferences for analgesia during and after surgery.
Experimental group:The experimental group will receive preemptive pain management before surgery, an opioid-free strategy during surgery, and an opioid-sparing multimodal pain management protocol afte

Sponsors

Guizhou Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Females aged 18-75 years; 2. Gynecological laparotomy is planned.

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent; 2. Inability to understand written or spoken language; 3. ASA IV or V; 4. Plan to enter the ICU for more than one night; 5. Pregnancy; 6. Current or long-term (more than 7 days prior to visit) use of opioids or opioid antagonist medications.

Design outcomes

Primary

MeasureTime frame
VAS score 1 hour after surgery;VAS score 6 hours after surgery;VAS score 24 hours after surgery;VAS score 48 hours after surgery;VAS score 72 hours after surgery;VAS score 30 days after surgery;

Secondary

MeasureTime frame
72-hour postoperative opioid use;Time to Bowel Movement;Time to Oral Intake;Time to Ambulation;Post-operative Nausea and Vomiting;hospital stay within 30 days;Readmission 30 days postoperatively;Patient Recovery Quality Assessment QoR-15;Occurrence of serious and minor complications within 30 days after surgery;Cost per patient;

Countries

China

Contacts

Public ContactFang Kaiyun

Guizhou Provincial People's Hospital

fangkaiyun@sina.cn+86 13985533277

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026