Local Infiltration Analgesia After Abdominal Hysterectomy (LIA)

Göteborg University

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: ropivacaine, ketorelac and epinephrine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01782781

LIA-AH-1

Details and patient eligibility

About

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.

Full description

The study is a controlled, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden. The injectant mixture consists of 300 mg ropivacaine mixed with 30 mg ketorolac and 0.5 mg epinephrine. Total volume of the solution is 156 ml. The normal saline injection is used in the control group in the same manner as in the LIA group. The parameters which would be evaluated are consumption of morphine, pain intensity and side effects.

The primary objective is to evaluate whether local infiltration analgesia (LIA) into the operating field will reduce morphine consumption during the first 24 postoperative hours in patients undergoing abdominal hysterectomy (AH).

Secondary end-points are pain intensity, incidence of nausea and vomiting, sedation intensity.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring abdominal hysterectomy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Group P

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: ropivacaine, ketorelac and epinephrine