Postoperative Pain
Conditions
Keywords
Transversus Abdominis Plane catheter, TAP catheter
Brief summary
Major abdominal surgery is associated with postoperative pain. Transversus Abdominis Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal surgery. However a single block has a short effect of up to 12 hours depending on the type local-anesthetics used. With this study we wish to investigate the possibilities to place a TAP-catheter in order to prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP catheter and to study the pain and the opioid requirements of patients undergoing elective colon-resection when given a TAP-catheter preoperatively. Our hypothesis is that it is practical and technical possible to place bilateral TAP-catheters pre-operatively and that pain and opioid-requirements will be low.
Detailed description
Postoperative pain is a major challenge in the work of anesthesia. Epidural catheter is the golden standard for postoperative pain management after major abdominal surgery. However a number of patient have absolute or relative contraindication to the placement of an epidural catheter. It is therefore necessary to find a good alternative to epidural catheter. Transversus abdominis plane(TAP) block has been shown to provide analgesia of the abdominal wall and reduce opioid-requirements and pain after abdominal surgery. However the effect of a TAP block is limited to the time of efficacy of the local analgesic used. Placing a TAP-catheter in order to prolong the effect of the TAP-block by repeatedly bolus-injections in the TAP-catheters has only been sporadically described and so far never investigated in a systematic way. We will investigate the practical and technical possibility to place bilateral ultrasound-guided TAP-catheters pre-operatively on patients undergoing elective colon-resection. Further more we will evaluate the pain and opioid-requirement postoperatively.
Interventions
PROCEDUREPlacing bilateral TAP-catheters preoperatively
Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery.
DRUGBupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters
Intermittent boluses of Bupivacain 2.5 mg/ml with epinephrine, 20 ml in each catheter every 12 hours for the first 2 postoperative days.
Sponsors
University of Aarhus
Aalborg University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective open colon-resection * adult * written and informed consent
Exclusion criteria
* re-operation within the first 48 hours * need for sedation and ventilator-support postoperatively * accidental removal of catheter within the first 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 | 0-36 hours postoperative | NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Requirements Postoperative | 48 hours from arriving in the post anesthesia care unit. | Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Ultrasoundguide TAP-catheter All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Bilateral Ultrasoundguide TAP-catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age Continuous | 66 years STANDARD_DEVIATION 9 |
| Region of Enrollment Denmark | 15 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Postoperative Pain Using Numerical Rating Scale (NRS) 0-10
NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing.
Time frame: 0-36 hours postoperative
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bilateral Ultrasoundguide TAP-catheter | Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 | NRS at rest, all times | 3 Units on Numerical Rating Score |
| Bilateral Ultrasoundguide TAP-catheter | Postoperative Pain Using Numerical Rating Scale (NRS) 0-10 | Overall NRS when coughing, all times | 5 Units on Numerical Rating Score |
Secondary
Opioid Requirements Postoperative
Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine.
Time frame: 48 hours from arriving in the post anesthesia care unit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bilateral Ultrasoundguide TAP-catheter | Opioid Requirements Postoperative | 35 mg iv morphin equivalent |