Speed: Recovery and Analgesia After Surgery for Gynecological Cancer

• Sponsor: Lena Nilsson (Other)
• Overall Status: Completed
• CT.gov ID: NCT02026687
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecological Cancer	Drug: Epidural; Drug: Intrathecal	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Will Intrathecal Analgesia Contribute to a Faster Recovery Compared With Epidural Analgesia After Open Surgery for Gynecological Cancer. An Open Controlled Randomized Study.
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Length of Stay [Participants will be followed for the duration of hospital stay, an expected average of 4 days]

   From day of surgery (Day 0) until discharge after surgery

Secondary Outcome Measures

1. Change in Quality of Life [Preoperatively and until 6 weeks after surgery]

   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.

Other Outcome Measures

1. Change in Pain [Day of surgery (day 0) until 6 weeks after surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Linköping		Sweden	581 85

Sponsors and Collaborators

• Lena Nilsson

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lena Nilsson, MD. PhD. Assoc professor., University Hospital, Linkoeping
• ClinicalTrials.gov Identifier: NCT02026687
• Other Study ID Numbers: Speed
• First Posted: Jan 3, 2014
• Last Update Posted: Sep 24, 2019
• Last Verified: Sep 1, 2019

Study Results

Participant Flow

Arm/Group Title	Epidural Analgesia	Intrathecal Analgesia
Arm/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. Epidural	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. Intrathecal
Period Title: Overall Study
STARTED	40	40
COMPLETED	39	38
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Epidural Analgesia	Intrathecal Analgesia	Total
Arm/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. Epidural	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. Intrathecal	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.0 (14.5)	58.5 (8.5)	58.7 (8.9)
Sex: Female, Male (Count of Participants)
Female	40 100%	40 100%	80 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Sweden	40 100%	40 100%	80 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural	Spinal
Arm/Group Description	The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the	The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
Measure Participants	40	40
Median (Inter-Quartile Range) [days]	4.3	3.3

2. Secondary Outcome

Title	Change in Quality of Life
Description	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.
Time Frame	Preoperatively and until 6 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural	Spinal
Arm/Group Description	The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the	The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
Measure Participants	40	40
SF-36 Physical component summary score baseline	44	45
SF-36 Physical component summary score day 42	39	38
SF-36 mental component summary score baseline	46	46
SF-36 mental component summary score day 42	49	51

3. Other Pre-specified Outcome

Title	Change in Pain
Description	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.
Time Frame	Day of surgery (day 0) until 6 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural	Spinal
Arm/Group Description	The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the	The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
Measure Participants	40	40
Pain at rest Day 0	1.5	2.7
Pain at rest Day 1	1.6	3.2
Pain at rest Day 2	1.5	2.1
Pain at rest Day 3	2.9	1.4
Pain at rest Day 4	1.4	1.6
Pain at rest Day 5	1.1	1.2
Pain at rest Day 6	1.0	1.1
Pain at rest Day 7	1.1	1.0
Pain at rest Day 14	0.8	0.7
Pain at rest Day 21	0.5	0.3
Pain at rest Day 28	0.2	0.2
Pain at rest Day 35	0.3	0.3
Pain at rest Day 42	0.5	0.1

Adverse Events

Arm/Group Title	Epidural		Spinal
Arm/Group Description	The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the		The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
All Cause Mortality
	Epidural		Spinal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Epidural		Spinal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/40 (5%)		7/40 (17.5%)
Surgical and medical procedures
Intensive care treatment	1/40 (2.5%)	1	1/40 (2.5%)	1
Surgical intervention	1/40 (2.5%)	1	6/40 (15%)	6
Other (Not Including Serious) Adverse Events
	Epidural		Spinal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/40 (42.5%)		14/40 (35%)
Surgical and medical procedures
Deviation from normal postoperative cause	13/40 (32.5%)	13	8/40 (20%)	8
Pharmacological treatment	6/40 (15%)	6	6/40 (15%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.