Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

treatment: Tenoxicam; control: placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

care provider and participant were masked

Study Groups

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Tenoxicam

nonsteroidal anti-inflammatory drug (NSAID)

Group Type ACTIVE_COMPARATOR

Tenoxicam

Intervention Type DRUG

nonsteroidal anti-inflammatory drug (NSAID)

placebo

equal volume of normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

equal volume of normal saline

Interventions

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Tenoxicam

nonsteroidal anti-inflammatory drug (NSAID)

Intervention Type DRUG

Placebo

equal volume of normal saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No