Postoperative Pain
Conditions
Keywords
transversus abdominis plane block, local infiltration, ropivacaine, heart rate variability, postoperative analgesia
Brief summary
Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer side effect. For example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery. For abdominal surgery, both local infiltration and TAP block target on relieving somatic pain. Local anesthetic wound infiltration is easy to perform with low risk. As the advancement of ultrasound technology, performing the TAP block also becomes easier, safer and more accurate. But whether LA infiltration or TAP block is better for the multimodal analgesia regimen remains unclear. This study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. The investigators hypothesized that TAP block may be more effective than LA infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.
Interventions
PROCEDUREtransversus abdominis plane block
bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
PROCEDURElocal infiltration
local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
PROCEDUREPatient controlled analgesia
postoperative analgesia with intravenous patient controlled analgesia with morphine
Sponsors
Taipei Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult (20\ 65y/o) * American Society of Anesthesiologists (ASA) physical status I\ II * Patients scheduled for regular abdominal surgery under general anesthesia
Exclusion criteria
* ASA physical status ≥ 3 * Allergy to morphine or local anesthetics * Morphine tolerance * Drug abuse or addiction * Bleeding tendency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score (NRS: Numerical Rating Scale) | postoperative 24 hour dynamic | pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome. |
| Opioid Consumption | postoperative 48 hour | opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Analgesic Use | postoperative 1, 6, 12, 24, 36, 48 hour | — |
| Rescue Antiemetics Use | postoperative 1, 6, 12, 24, 36, 48 hour | — |
| Time to the First Request of Analgesics | an expected average of 5 days | participants will be followed for the duration of hospital stay |
| Pruritus | postoperative 1, 6, 24, 48 hour | — |
| Sedation Scale | postoperative 1, 6, 24, 48 hour | — |
| Heart Rate Variability | preoperative, postoperative 1 hour and 1 day | — |
| Time to Flatus | an expected average of 5 days | participants will be followed for the duration of hospital stay |
| Length of Hospital Stay | an expected average of 5 days | participants will be followed for the duration of hospital stay |
| Number of Participants With Intervention-related Complication | an expected average of 5 days | participants will be followed for the duration of hospital stay |
| Quality of Recovery 40 | postoperative 48 hour | — |
| Nausea and Vomiting Categorical Score | postoperative 1, 6, 24, 48 hour | — |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAP Block postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine | 36 |
| Local Infiltration postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine | 36 |
| PCA Only postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.
Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine | 36 |
| Total | 108 |
Baseline characteristics
| Characteristic | Total | TAP Block | Local Infiltration | PCA Only |
|---|---|---|---|---|
| Age, Continuous | 40.85 years STANDARD_DEVIATION 6.65 | 40.17 years STANDARD_DEVIATION 7.28 | 39.69 years STANDARD_DEVIATION 5.38 | 42.69 years STANDARD_DEVIATION 6.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 108 Participants | 36 Participants | 36 Participants | 36 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 108 participants | 36 participants | 36 participants | 36 participants |
| Sex/Gender, Customized Female | 108 participants | 36 participants | 36 participants | 36 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Opioid Consumption
opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).
Time frame: postoperative 48 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAP Block | Opioid Consumption | 27.69 mg | Standard Deviation 19.2 |
| Local Infiltration | Opioid Consumption | 28.33 mg | Standard Deviation 15.89 |
| PCA Only | Opioid Consumption | 21.53 mg | Standard Deviation 16.99 |
Primary
Pain Score (NRS: Numerical Rating Scale)
pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Time frame: postoperative 24 hour dynamic
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAP Block | Pain Score (NRS: Numerical Rating Scale) | 4.50 units on a scale | Standard Error 1.98 |
| Local Infiltration | Pain Score (NRS: Numerical Rating Scale) | 4.81 units on a scale | Standard Error 1.77 |
| PCA Only | Pain Score (NRS: Numerical Rating Scale) | 4.17 units on a scale | Standard Error 1.25 |
Secondary
Heart Rate Variability
Time frame: preoperative, postoperative 1 hour and 1 day
Secondary
Length of Hospital Stay
participants will be followed for the duration of hospital stay
Time frame: an expected average of 5 days
Secondary
Nausea and Vomiting Categorical Score
Time frame: postoperative 1, 6, 24, 48 hour
Secondary
Number of Participants With Intervention-related Complication
participants will be followed for the duration of hospital stay
Time frame: an expected average of 5 days
Secondary
Pruritus
Time frame: postoperative 1, 6, 24, 48 hour
Secondary
Quality of Recovery 40
Time frame: postoperative 48 hour
Secondary
Rescue Analgesic Use
Time frame: postoperative 1, 6, 12, 24, 36, 48 hour
Secondary
Rescue Antiemetics Use
Time frame: postoperative 1, 6, 12, 24, 36, 48 hour
Secondary
Sedation Scale
Time frame: postoperative 1, 6, 24, 48 hour
Secondary
Time to Flatus
participants will be followed for the duration of hospital stay
Time frame: an expected average of 5 days
Secondary
Time to the First Request of Analgesics
participants will be followed for the duration of hospital stay
Time frame: an expected average of 5 days