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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP block | Experimental | 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. |
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| Local infiltration | Active Comparator | 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. |
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| PCA only | Active Comparator | postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transversus abdominis plane block | Procedure | bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | postoperative 24 hour dynamic |
| Opioid Consumption | opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours). | postoperative 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Scale | postoperative 1, 6, 24, 48 hour | |
| Nausea and Vomiting Categorical Score | postoperative 1, 6, 24, 48 hour | |
| Rescue Analgesic Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chuen-Chau Chang, PhD | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | Taiwan | 110 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| local infiltration | Procedure | local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure |
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| Patient controlled analgesia | Procedure | postoperative analgesia with intravenous patient controlled analgesia with morphine |
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| 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 | participants will be followed for the duration of hospital stay | an expected average of 5 days |
| Pruritus | postoperative 1, 6, 24, 48 hour |
| Quality of Recovery 40 | postoperative 48 hour |
| Heart Rate Variability | preoperative, postoperative 1 hour and 1 day |
| Time to Flatus | participants will be followed for the duration of hospital stay | an expected average of 5 days |
| Length of Hospital Stay | participants will be followed for the duration of hospital stay | an expected average of 5 days |
| Number of Participants With Intervention-related Complication | participants will be followed for the duration of hospital stay | an expected average of 5 days |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | postoperative 24 hour dynamic |
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| Primary | Opioid Consumption | opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours). | Posted | Mean | Standard Deviation | mg | postoperative 48 hour |
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| Secondary | Sedation Scale | Not Posted | postoperative 1, 6, 24, 48 hour | |||||||||||||||||||||||||||||||||||||||
| Secondary | Nausea and Vomiting Categorical Score | Not Posted | postoperative 1, 6, 24, 48 hour | |||||||||||||||||||||||||||||||||||||||
| Secondary | Rescue Analgesic Use | Not Posted | postoperative 1, 6, 12, 24, 36, 48 hour | |||||||||||||||||||||||||||||||||||||||
| Secondary | Rescue Antiemetics Use | Not Posted | postoperative 1, 6, 12, 24, 36, 48 hour | |||||||||||||||||||||||||||||||||||||||
| Secondary | Time to the First Request of Analgesics | participants will be followed for the duration of hospital stay | Not Posted | an expected average of 5 days | ||||||||||||||||||||||||||||||||||||||
| Secondary | Pruritus | Not Posted | postoperative 1, 6, 24, 48 hour | |||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Recovery 40 | Not Posted | postoperative 48 hour | |||||||||||||||||||||||||||||||||||||||
| Secondary | Heart Rate Variability | Not Posted | preoperative, postoperative 1 hour and 1 day | |||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Flatus | participants will be followed for the duration of hospital stay | Not Posted | an expected average of 5 days | ||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay | participants will be followed for the duration of hospital stay | Not Posted | an expected average of 5 days | ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Intervention-related Complication | participants will be followed for the duration of hospital stay | Not Posted | an expected average of 5 days |
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 36 | 0 | 36 | ||
| EG001 | 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 | 0 | 36 | 0 | 36 | ||
| EG002 | 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 | 0 | 36 | 0 | 36 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hsiao-Chien Tsai | Taipei medical university hospital | +886-2-27372181 | 8310 | hctsai.anes@gmail.com |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000698 | Analgesia |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | 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 |
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