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0.05 Versus 0.1 mg Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy

M

Mahidol University

Status and phase

Unknown
Phase 4

Conditions

Vaginal Hysterectomy
Pain

Treatments

Drug: Spinal morphine 0.1 mg
Drug: Spinal morphine 0.05 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT01079754
Si 073/2010

Details and patient eligibility

About

This study aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty.

Enrollment

72 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female ASA physical status 1-3
  • Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
  • Be able to operate patient-controlled analgesia (PCA)

Exclusion criteria

  • Allergy to the study drugs
  • History of bleeding tendency
  • Infection at the back
  • Refuse to spinal anesthesia
  • History of CAD or CVA

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups

Spinal morphine 0.05 mg
Experimental group
Description:
Patient received spinal morphine 0.05 mg
Treatment:
Drug: Spinal morphine 0.05 mg
Spinal morphine 0.1 mg
Active Comparator group
Description:
Patient received spinal morphine 0.1 mg
Treatment:
Drug: Spinal morphine 0.1 mg

Trial contacts and locations

1

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Central trial contact

Sirilak Suksompong, MD

Data sourced from clinicaltrials.gov

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