Trial Outcomes & Findings for Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery (NCT NCT00508300)

Results Overview

Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

30 days

Results posted on

2020-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Epidural Epidural Analgesia (Th 8-9) Epidural analgesia: Thoracic epidural analgesia until day 2	Patient-controlled Analgesia Patient controlled analgesia (morphine-based) Patient controlled analgesia: Patient controlled analgesia (morphine-based)
Overall Study STARTED	67	61
Overall Study COMPLETED	65	57
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidural n=65 Participants epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.	Patient-controlled Analgesia n=57 Participants In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.	Total n=122 Participants Total of all reporting groups
Age, Continuous	63.1 years STANDARD_DEVIATION 15.1 • n=65 Participants	61.2 years STANDARD_DEVIATION 17.8 • n=57 Participants	62.5 years STANDARD_DEVIATION 16.3 • n=122 Participants
Sex: Female, Male Female	28 Participants n=65 Participants	23 Participants n=57 Participants	51 Participants n=122 Participants
Sex: Female, Male Male	37 Participants n=65 Participants	34 Participants n=57 Participants	71 Participants n=122 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Switzerland	65 participants n=65 Participants	57 participants n=57 Participants	122 participants n=122 Participants

PRIMARY outcome

Timeframe: 30 days

Population: accorindg to intention-to-treat principle

Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25

Outcome measures

Outcome measures
Measure	Epidural n=65 Participants epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.	Patient-controlled Analgesia n=57 Participants In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.
Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal))	5 days Interval 3.0 to 7.5	4 days Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

Adverse Events

Epidural

Serious events: 13 serious events

Other events: 0 other events

Deaths: 2 deaths

Patient-controlled Analgesia

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Epidural n=65 participants at risk epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.	Patient-controlled Analgesia n=57 participants at risk In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.
Surgical and medical procedures major complications according to clavien: 3+4	20.0% 13/65 • Number of events 13 • Adverse event data were collected until 30 days after surgery.	8.8% 5/57 • Number of events 5 • Adverse event data were collected until 30 days after surgery.

Other adverse events

Adverse event data not reported

Additional Information

martin hübner

lausanne university hospital

Phone: +41795561506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place