Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy (DTMPCA)

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Abdominal Surgeries; Post Operative Analgesia; Patient-Controlled Analgesia

Treatments: Drug: Dexamethasone Sodium Phosphate Injection; Other: 0.9% Saline

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00564603

06NMUZ028

NMU-2579-5FW

Details and patient eligibility

About

Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.

Enrollment: 300 patients

Sex: Female

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ASA physical status I-II
2. Chinese
3. 19-64yr
4. Uterus myoma

Exclusion criteria

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
2. Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
4. Those who were not willing to or could not finish the whole study at any time.
5. Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Saline with same volume added to tramadol infusion combined with morphine PCA.

Treatment:

Other: 0.9% Saline

2

Active Comparator group

Description:

Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.

Treatment:

Drug: Dexamethasone Sodium Phosphate Injection