Recovery and Analgesia After Surgery for Gynecological Cancer

NCT02026687 | Completed Phase 4 Results DMC

• 1 other identifier: Speed
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecological Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Quality of Life

  Preoperatively and until 6 weeks after surgery

Other Outcomes (1)

• Change in Pain

  Day of surgery (day 0) until 6 weeks after surgery

Study Arms (2)

Epidural analgesia

ACTIVE COMPARATOR

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

Intrathecal analgesia

EXPERIMENTAL

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

Interventions

Epidural DRUG

Epidural analgesia

Intrathecal DRUG

Intrathecal analgesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Lena Nilsson: lead

Study Sites (1)

University Hospital

Linköping, 581 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30837253 DERIVED

MeSH Terms

Interventions

Injections, Epidural; Injections, Spinal

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr Lena Nilsson
• Organization: Dept of anaesthesia, Linköping University Hospital, Sweden

lena.nilsson@regionostergotland.se

0046101030000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. PhD. Assoc professor.

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 3, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 24, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-09

Locations

SE (1)