Recovery and Analgesia After Surgery for Gynecological Cancer (Speed)

Lena Nilsson

Status and phase: Completed; Phase 4

Conditions: Gynecological Cancer

Treatments: Drug: Intrathecal; Drug: Epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT02026687

Speed

Details and patient eligibility

About

The purpose of the study is to compare epidural analgesia and intrathecal analgesia for explorative laparotomy through a middle-line incision for gynecological cancer in a fast track program to se if there is any difference in recovery. Length of stay is analyzed together with self-rate quality of life.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with gynecological cancer (suspected or verified) planned for explorative laparotomy through a middle-line incision with a curative purpose.
• WHO performance status < 2.
• American Society of Anesthesiologists class 1-2.
• Women that understand and can express themselves in Swedish.
• Women that after verbal and written information accept participation in the study and have signed an informed consent.

Exclusion criteria

• Women where surgery is expected to include part/s, other than the abdominal surgery, where intrathecal or epidural analgesia is not expected to be effective
• Women with contra indications for intrathecal or epidural anesthesia.
• Women who are physically disabled and therefore nor expected to be mobilized on the day after surgery in the same way as non-disabled.
• Women with a mental retardation that makes it impossible to fill in the relevant questionnaires or makes it impossible to understand the meaning of participation, or if it is ethically doubtful to include the woman.
• Women with psychiatric or mental disorder that according to the responsible physician makes it unsuitable to participate in the study .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Epidural analgesia

Active Comparator group

Description:

The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.

Treatment:

Drug: Epidural

Intrathecal analgesia

Experimental group

Description:

The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.

Treatment:

Drug: Intrathecal