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Parcetamol/tramadol for Postoperative Pain of Benign Anorectal Diseases

Parcetamol/tramadol for Postoperative Pain of Benign Anorectal Diseases: A Single-center, Double-blind, Placebo-controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001467
Enrollment
Unknown
Registered
2011-08-15
Start date
2010-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemorrhoids, anal fistulas or anal fissure

Interventions

A:Paracetamoland Tramadol Hydrochloride Tablets 400mg, po, qd, three days
B:Placebo, 400mg, po, qd, three days

Sponsors

The sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men or women patients aged 16 years to 60 years with benign anorectal diseases: hemorrhoids (with symptomatic hemorrhoidal diseases and diagnosed with grade III and IV hemorrhoids, the severity of hemorrhoidal disease was classified according to grading system described by Salvati[4], as grade I (hemorrhoids with bleeding but without prolapse), grade II (hemorrhoids with bleeding and protrusion with spontaneous reduction), grade III (hemorrhoids with bleeding and protrusion that require manual reduction), and grade IV (hemorrhoids that are prolapsed and cannot be replaced), fissure in ano (included chronic anal fissure and acute fissure with ineffective expectant treatment and insufferable symptoms: bleeding, itching or pain) or simple anal fistulas(defined as the entire fistula track from internal opening to external opening with identification and obliteration of primary and secondary tracks)[5] , which would need treatment by operation. The operations for the diseases above had common features: wounds with un-sutures and no catheters would be found round the perianal. Especially, as hemorrhoids surgery must combination Milligan-Morgan hemorrhoidectomy, whatever procedure for prolapse and hemorrhoids (PPH), tissue-selecting therapy (TST) or band ligation had been did. The fissure in ano was operated by anal internal sphincter-lysis. As the simple anal fistulas were used fistulotomy but fistulectomy. Routine blood test, liver function test (LFTs), blood urea nitrogen (BUN), blood creatinine (Cr), uric acid (UA), prothrombin time(PT), activated partial thromboplastin time(APTT) and thrombin time(TT) would be claimed normal before surgery.

Exclusion criteria

Exclusion criteria: People had any allergic histories about acetaminophen or tramadol, cranio-cerebral disease, chemical dependency or a long-term administration for pain were excluded. Patients who had previously taken tricyclic antidepressants, non-steroidal anti-inflammatory drug or opioid drug in the latest three months were excluded as well.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;

Secondary

MeasureTime frame
Added the amount of pain drugs;Urinary retention;The laboratory test result;

Countries

China

Contacts

Public ContactDong-Lin Ren
rxyz111@yahoo.com.cn+86 13600001818

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026