Is recovery after surgery for gynecological cancer affected by the choice of regional anestesia?

Will intrathecal analgesia contribute to a faster recovery compared with epidural analgesia after open surgery for gynecological cancer. An open controlled randomized study. - Speed

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001873-25-SE

Enrollment

Registered

2013-05-29

Start date

2013-08-29

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery after open abdominal surgery for gynecological cancer

Interventions

Trade Name: Carbocain adrenalin 20 mg/ml+5mikrogram/ml Pharmaceutical Form: Injection Trade Name: Catapresan 150 mikrogram/ml Pharmaceutical Form: Injection Trade Name: Fentanyl B. Braun 50 mikrogra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women 18 – 70 years. • Women with gynecological cancer (suspected or verified) planned for explorative laparatomy through a middle-line with a curative purpose. • WHO performance status =65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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 women. • Women with severe psychiatric or mental disorder and any condition, which would exclude the women from conducting regional anesthesia in the standardized manner of the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: - to decide if one in a fast track program by the use of intrathecal analgesia and standardized criteria for discharge will have a faster physical recovery, so a larger proportion of patients can be discharged on the third day after surgery, than if epidural analgesia has been used per- and postoperatively. - to decide if the use of perioperative intrathecal analgesia contributes to a faster recovery of health related quality of health, less postoperative symptom and influence on vital signs compared with postoperative epidural analgesia ;Secondary Objective: -to analyze if there is a correlation between the effectiveness of the perioperative methods for analgesia and the preoperative psychological characteristics or thresholds for pressure and temperature. ;Primary end point(s): Length of stay. larger proportion of patients being discharged on the third postoperative day. ;Timepoint(s) of evaluation of this end point: Third postoperative day. Time of hospital stay after surgery.	—

Measure

Time frame

Main Objective: - to decide if one in a fast track program by the use of intrathecal analgesia and standardized criteria for discharge will have a faster physical recovery, so a larger proportion of patients can be discharged on the third day after surgery, than if epidural analgesia has been used per- and postoperatively. - to decide if the use of perioperative intrathecal analgesia contributes to a faster recovery of health related quality of health, less postoperative symptom and influence on vital signs compared with postoperative epidural analgesia ;Secondary Objective: -to analyze if there is a correlation between the effectiveness of the perioperative methods for analgesia and the preoperative psychological characteristics or thresholds for pressure and temperature. ;Primary end point(s): Length of stay. larger proportion of patients being discharged on the third postoperative day. ;Timepoint(s) of evaluation of this end point: Third postoperative day. Time of hospital stay after surgery.

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Secondary

Measure	Time frame
Secondary end point(s): The patients’ self-rated quality of life as measured by Q-5D and SF-36. Prevalence and level of postoperative symptoms (pain at rest and at mobilization/coughing, nausea, vomiting, pruritus, postoperative ileus (air and feces), time with urinary bladder catheter, i.v. fluids, time spent in bed/out of bed per day; consumption of analgesics (total, morphine); vital signs (blood pressure, heart rate, sedation, respiratory depression). ;Timepoint(s) of evaluation of this end point: Baseline, every day for day 0-7, once a week for the following 6 weeks	—

Measure

Time frame

Secondary end point(s): The patients’ self-rated quality of life as measured by Q-5D and SF-36. Prevalence and level of postoperative symptoms (pain at rest and at mobilization/coughing, nausea, vomiting, pruritus, postoperative ileus (air and feces), time with urinary bladder catheter, i.v. fluids, time spent in bed/out of bed per day; consumption of analgesics (total, morphine); vital signs (blood pressure, heart rate, sedation, respiratory depression). ;Timepoint(s) of evaluation of this end point: Baseline, every day for day 0-7, once a week for the following 6 weeks

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Countries

Sweden

Contacts

Public ContactLena Nilsson

County Council of Östergötland

lena.nilsson@lio.se+460101031838

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026