Local Infiltration Analgesia After Abdominal Hysterectomy

NCT01782781 | Completed Phase 3

• 1 other identifier: LIA-AH-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery.

Conditions

Pain

Keywords

Analgesia; Local infiltration analgesia; Pain, relief; Pain, Postoperative; Ropivacaine; Ketorolac; Epinephrine; Adrenergic Agonists; Sympathomimetics; Therapeutic Uses; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Opioids; Morphine; Pain; Postoperative Complications; Physiological Effects of Drugs; Anesthetics, Local; Anesthetics

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  0-24 hours postoperatively

Secondary Outcomes (3)

• Pain intensity (NRS, Numeric Rating Score 0-10)

  0-24 hours postoperatively

• Incidence of nausea and vomiting

  0-24 hours postoperatively

• Sedation intensity (Ramsey scale)

  0-24 hours postoperatively

Study Arms (2)

Group P

PLACEBO COMPARATOR

Group P (Placebo) receives a local infiltration of saline in the operating field and ketorolac iv. In Group P the injectant consists of saline, total volume 156 mL. This is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. Ketorolac 30 mg (1 mL) is also injected iv.

Drug: Placebo

Group A

ACTIVE COMPARATOR

Group A (Active) receives a local infiltration of ropivacaine, ketorolac and epinephrine in the operating field and saline iv. Drug: ropivacaine, ketorelac and epinephrine In Group A the injectant mixture consists of ropivacaine 300 mg mixed with 30 mg ketorolac and 0.5 mg epinephrine, total volume 156 mL. This mixture is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. One mL saline is also injected iv.

Drug: ropivacaine, ketorelac and epinephrine

Interventions

ropivacaine, ketorelac and epinephrine DRUG

Active group

Also known as: Narop, Toradol and adrenaline

Group A

Placebo DRUG

Placebo group

Also known as: Saline

Group P

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring abdominal hysterectomy

You may not qualify if:

• Body mass index \> 35
• American Society of Anesthesiologists classification \> 3
• Renal dysfunction
• Allergic to acetylsalicylic acid
• Unwilling to provide informed consent

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital

Gothenburg, SE41385, Sweden

Location

MeSH Terms

Conditions

Pain; Agnosia; Pain, Postoperative; Postoperative Complications

Interventions

Ropivacaine; Epinephrine; Ketorolac Tromethamine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sven-Egron Thorn, MD, PhD

  Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

  PRINCIPAL INVESTIGATOR

• Anil Gupta, MD, PhD

  Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden

  STUDY CHAIR

• Ove Carlsson, MD

  Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

  STUDY CHAIR

• Karin Olausson, MD

  Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

  STUDY CHAIR

• Olof Eckre, MD, PhD

  Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

  STUDY CHAIR

• Sven-Erik Ricksten, MD,PhD

  Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

  STUDY CHAIR

• Fatma Backman, MD

  Dept. of Gynecological Surgery, Orebro University Hospital, Orebro, Sweden

  STUDY CHAIR

• Elisabeth Stadberg, MD

  Dept. of Gynecological Surgery, Sahlgrenska University Hospital, Goteborg, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: February 4, 2013
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2014-10

Locations

SE (1)