Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia

Overview

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 Title of Study: “Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia in Patients Receiving Abdominal and Non-abdominal Surgeries.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 31, 2022

Detailed 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.

Interventions

  • Drug: Tenoxicam
    • nonsteroidal anti-inflammatory drug (NSAID)
  • Drug: Placebo
    • equal volume of normal saline

Arms, Groups and Cohorts

  • Active Comparator: Tenoxicam
    • nonsteroidal anti-inflammatory drug (NSAID)
  • Placebo Comparator: placebo
    • equal volume of normal saline

Clinical Trial Outcome Measures

Primary Measures

  • morphine consumption
    • Time Frame: until postoperative day7
    • morphine consumption after breast cancer surgery

Secondary Measures

  • orocecal transmit time,
    • Time Frame: preoperative and postoperative day 1
    • smal intestinal function

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Ya-Jung Cheng, MD,PhD, chengyj@ntu.edu.tw

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