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Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia

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National Taiwan University

Status

Not yet enrolling

Conditions

Gastrointestinal Recovery

Treatments

Drug: Placebo
Drug: Tenoxicam

Study type

Interventional

Funder types

Other

Identifiers

NCT04314310
201912245RINB

Details and patient eligibility

About

breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer.

Full description

thrity patients participated in this randomized, single-blined study. Before and at the postoperative day 1, the bowel function (orocecal transmit time) were measured. Before induction of general anesthesia, patients recieved a bolus of intravenous Tenoxicam or an equal volume of saline (control group). Pain score and opioid consumption were recorded in the postoperative period and then daily for 1 week.

Enrollment

30 estimated patients

Sex

Female

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA I to II Breast cancer patients Mastectomy or wide local excision + axillary note dissection

Exclusion criteria

  • Preexisting malignancy Chronic infection Previous pain condition Diabetes Thyroid disorder Severe cardiac, renal or hepatic disease Previous breast surgery Psychiatric illness Neurological disease Contraindication for tenoxicam or morphine use

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

Tenoxicam
Active Comparator group
Description:
nonsteroidal anti-inflammatory drug (NSAID)
Treatment:
Drug: Tenoxicam
placebo
Placebo Comparator group
Description:
equal volume of normal saline
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Central trial contact

Ya-Jung Cheng, MD,PhD

Data sourced from clinicaltrials.gov

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