Preemptive Analgesia With Amitryptyline for Prevention of Pain in Women After Hysterectomy

NCT03587025 | Completed Phase 3

• 1 other identifier: IMIP
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether amitryptyline is effective in the prevention of pain in women after a total abdominal hysterectomy.

Conditions

Pain, Postoperative

Keywords

amitryptyline; Analgesia; Hysterectomy; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Effectiveness of amitryptyline in the prevention of post-operative pain in women undergoing total abdominal hysterectomy, twenty-four hours after surgery

  The postoperative pain will be measured twenty-four hours after surgery, using the visual pain scale (0 - no pain to 10 - very hard pain)

  Twenty-four hours after surgery

Secondary Outcomes (11)

• Intensity of acute postoperative pain six hours after the procedure

  Six hours after the procedure

• Intensity of acute postoperative pain twelve hours after the procedure

  Twelve hours after the procedure

• Intensity of acute postoperative pain twenty-four hours after the procedure

  Twenty-four hours after the procedure

• Intensity of acute postoperative pain forty-eight hours after the procedure

  forty-eight hours after the procedure

• Records of rescue analgesia

  From the end of the procedure until 48 hours after that

Study Arms (2)

Amitryptyline

ACTIVE COMPARATOR

Patients who will be take amitryptyline, 75mg, only use, 30min before surgery.

Drug: Amitriptyline

Placebo

PLACEBO COMPARATOR

Patients who will be take placebo 30min before surgery.

Drug: Placebo

Interventions

Amitriptyline DRUG

Amitriptyline compared with placebo for preemptive analgesia in women after abdominal hysterectomy.

Amitryptyline

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women scheduled for total abdominal hysterectomy for benign conditions (e.g. hemorrhagic and / or uterine fibroid disorder);
• Age between 18 and 60;

You may not qualify if:

• Endometriosis;
• Abnormal cervicovaginal smears;
• Uterine prolapse;
• Patients with a history of intolerance to opioids or narcotics;
• Patients with contraindications to the use of amitriptyline (e.g., ischemic heart disease, glaucoma)
• addicted to alcohol or drugs;
• Use of analgesics in the 24 hours prior to the possible administration of amitriptyline;
• Failure to provide informed consent;
• Different anesthesia from spinal anesthesia

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

FCM CG - Faculdade de Ciências Médicas de Campina Grande

Campina Grande, Paraíba, 58411-120, Brazil

Location

Related Publications (8)

• Arsenault A, Sawynok J. Perisurgical amitriptyline produces a preventive effect on afferent hypersensitivity following spared nerve injury. Pain. 2009 Dec;146(3):308-314. doi: 10.1016/j.pain.2009.08.003. Epub 2009 Sep 11.

  PMID: 19748184 BACKGROUND

• Brandsborg B. Pain following hysterectomy: epidemiological and clinical aspects. Dan Med J. 2012 Jan;59(1):B4374.

  PMID: 22239844 BACKGROUND

• Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b013e3181c4273a. Epub 2009 Nov 12.

  PMID: 19910619 BACKGROUND

• Clarke-Pearson DL, Geller EJ. Complications of hysterectomy. Obstet Gynecol. 2013 Mar;121(3):654-673. doi: 10.1097/AOG.0b013e3182841594.

  PMID: 23635631 BACKGROUND

• Goodwin SA. A review of preemptive analgesia. J Perianesth Nurs. 1998 Apr;13(2):109-14. doi: 10.1016/s1089-9472(98)80095-6.

  PMID: 9592452 BACKGROUND

• Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

  PMID: 16698416 BACKGROUND

• Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology. 2002 Mar;96(3):725-41. doi: 10.1097/00000542-200203000-00032. No abstract available.

  PMID: 11873051 BACKGROUND

• Ajori L, Nazari L, Mazloomfard MM, Amiri Z. Effects of gabapentin on postoperative pain, nausea and vomiting after abdominal hysterectomy: a double blind randomized clinical trial. Arch Gynecol Obstet. 2012 Mar;285(3):677-82. doi: 10.1007/s00404-011-2023-6. Epub 2011 Aug 5.

  PMID: 21818576 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Guilherme V Mascena, PhD

  FCM-CG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 16, 2018
• Study Start: June 1, 2015
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

BR (1)