Recovery and Analgesia After Surgery for Gynecological Cancer (Speed)

Will Intrathecal Analgesia Contribute to a Faster Recovery Compared With Epidural Analgesia After Open Surgery for Gynecological Cancer. An Open Controlled Randomized Study.

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.

Study Overview

• Status: Completed
• Conditions: Gynecological Cancer
• Intervention / Treatment: Drug: Epidural; Drug: Intrathecal

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 581 85
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural analgesia; 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.	Drug: Epidural
Experimental: Intrathecal analgesia; 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.	Drug: Intrathecal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	From day of surgery (Day 0) until discharge after surgery	Participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	The questionnaire Short Form with 36 questions "SF-36" will be used preoperatively and at 6 weeks after surgery. The SF-36 consists of eight scaled subscores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental Health) and two Component summary scores (physical Component summary scoer, mental component summary score). A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Preoperatively and until 6 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Pain at rest will be assessed using a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Pain is documented on the day of surgery (day 0), 3 times daily postoperative day 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35 and 42. Scale: NRS Minimum value:0 Maximum value: 10. Higher scores indicate worse outcome.	Day of surgery (day 0) until 6 weeks after surgery

Collaborators and Investigators

• Sponsor: Lena Nilsson

Publications and helpful links

General Publications

• Kjolhede P, Bergdahl O, Borendal Wodlin N, Nilsson L. Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial. BMJ Open. 2019 Mar 4;9(3):e024484. doi: 10.1136/bmjopen-2018-024484.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: January 1, 2014
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 15, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Speed