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Effect of opioid-free analgesia on postoperative quality of recovery after gynecological laparoscopic surgery : a double-blind, randomized, controlled trial

Effect of opioid-free analgesia on postoperative quality of recovery after gynecological laparoscopic surgery : a double-blind, randomized, controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078569
Enrollment
Unknown
Registered
2023-12-12
Start date
2024-01-10
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

quality of postoperative recovery

Interventions

Opioid analgesia group:Patient-controlled analgesia using sufentanil after surgery
Opioid-free analgesia group:Patient-controlled analgesia using non-opioid drugs after surgery
non-opioid drugs included dexmedetomidine and esketamine

Sponsors

Peking University First Hospital Ningxia Women's and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >= 18 years old; ASA grade I-III; elective gynecological laparoscopic surgery under general anesthesia; patient-controlled intravenous analgesia is required after surgery.

Exclusion criteria

Exclusion criteria: Patients with pre-existing chronic pain; patients with language, psychological, or comprehension barriers; patients with a history of long-term analgesic use, opioid abuse, drug addiction, or alcoholism; patients with severe psychiatric disorders; patients with contraindications to dexmedetomidine, including those with preoperative left ventricular ejection fraction (LVEF) <30%, or with sick sinus syndrome, severe sinus bradycardia (heart rate <50 beats per minute), second-degree or higher atrioventricular block without a pacemaker; patients allergic to the study medications.

Design outcomes

Primary

MeasureTime frame
The area under the curve of visual analog scale for pain within 48 hours after surgery ;the postoperative quality of recovery score within 2 days after surgery;

Secondary

MeasureTime frame
Visual analogue scale ( VAS ) of pain at PACU, 12h, 24h, 36h and 48h after operation;The incidence of VAS score >3;The number of PCA triggers;The incidence of postoperative nausea and vomiting;nausea and vomiting score;Postoperative gastrointestinal function recovery time (first exhaust defecation time);Sleep quality score, anxiety and depression score;

Countries

China

Contacts

Public ContactYing Ren

Peking University First Hospital Ningxia Women's and Children's Hospital

403328967@qq.com+86 153 7895 5905

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 17, 2026