Tamculosin for urinary retention in hip fracture patients

Completed

Conditions: Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,

Registration Number: CTRI/2022/05/042897

Lead Sponsor: AIIMS Bhubaneswar

Brief Summary: This study will be a randomized, double-blind, placebo-controlled trial comparing perioperative tamsulosin therapy to placebo for the prevention of POUR in adult patients undergoing hip fracture surgery

**Participants:**

The adult patients with hip fractures admitted to the Department of Orthopaedics at AIIMS Bhubaneswar for surgical intervention will be included. The patients meeting the inclusion criteria will be recruited after obtaining their consent.

**Treatment allocation and randomization:**

The patients will be randomized to the treatment arm or placebo arm based on computer-generated randomizations codes. Group allocation will be concealed in a sealed opaque envelope by a third party (independent researcher) prior to the treatment. The participants and clinical investigators will remain blinded to the drugs.

**Interventions and management:**

The participants in the treatment group will receive tamsulosin 0.4 mg OD from the time of admission to two days postoperatively. The placebo group will receive a starch capsule in a similar manner.

**Perioperative course**

All hip fracture patients undergoing hip fracture fixation or arthroplasty will be assigned to one of the groups. The patient will be operated on under regional anesthesia or general anesthesia. They will be catheterized during surgical induction or just before the surgery. The postoperative pain medication will be uniform. All patients will receive Paracetamol 1gm qid. The Diclofenac and tramadol injection will be given on demand. The catheter will be removed the next day morning (within 24 hrs). The patient should be able to void normally within 6 hrs of catheter removal with a bladder scan volume of <200ml. If the patient will not be able to void within 6 hrs, he will be evaluated with a bladder scan. Inability to void within 6hrs, symptoms of abdominal discomfort or urinary retention, post-void residual bladder volume of >200 ml, and urinary retention of >200ml after 6 hrs of catheter removal will be considered as the development of POUR. The patient will be intermittently catheterized for 24 hours in case of abdominal discomfort and bladder volume >500ml. If it persists beyond 24 hours, the indwelling catheter will be placed and a urology consultation will be sought.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 118

Inclusion Criteria

1.All patients undergoing hip fracture surgery (ORIF or arthroplasty) 2.â‰¥18 years of age.
3.Patients willing to participate.

Exclusion Criteria

1.History of neurogenic bladder or urological problems requiring routine intermittent catheterization 2.Patients unable to take an oral medication 3.Patient who would require an indwelling catheter for other reasons, or patients who needed catheterisation during admission to the emergency for voiding difficulty 4.Patients with systolic blood pressure <100 mmhg or orthostatic hypotension 5.Pregnant women 6.Associate trauma of spine or pelvis 7.Patients taking medications for lower urinary tract symptoms or who had previously undergone prostatectomy 8.Patients with severe liver or kidney disease 9.Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir/ritonavir, lopinavir/ritonavir, or conivaptan), use of a 5-alpha reductase inhibitor medication, the use of sildenafil, tadalafil, or vardenafil, history of an allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, Terazosin, or phenoxybenzamine), 10.Uncontrolled concomitant illness including, but not limited to, ongoing or active infection 11.Congestive heart failure, unstable angina pectoris, cardiac arrhythmia, 12.Psychiatric illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Number of patients developing postoperative urinary retention (POUR)	6 hours of surgery

Secondary Outcome Measures

Name	Time	Method
1.No. of patients needing urinary catheter placement (unable to void, bladder scan with 500 mL residual urine or patient discomfort)	2.No. of intermittent catheterization

Trial Locations

Locations (1): AIIMS Bhubaneswar
🇮🇳
Khordha, ORISSA, India
AIIMS Bhubaneswar
🇮🇳Khordha, ORISSA, India
Dr Sujit Kumar Tripathy
Principal investigator
9438884155
sujitortho@aiimsbhubaneswar.edu.in