Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Clinton Township, Michigan, United States, 48038
- Henry Ford Macomb Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergoing laparoscopic sleeve gastrectomy
Exclusion Criteria:
- Conversion to open procedure
- Prior history of narcotic use (which will be defined as any narcotics used on a recreational basis or any narcotic used for pain relief without having had recent operation or injury)
- Current narcotic use at time of surgery
- Prolonged case time defined as >1 standard deviation over average time
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Early-operative TAP block
The TAP block will be administered after the placement of the camera port.
|
An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position.
Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected.
The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
|
Experimental: Late-operative TAP block
The TAP block will be administered at the completion of the case just before removing the camera port.
|
An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position.
Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected.
The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient reported pain
Time Frame: Immediately post-operatively (upon arrival to PACU). These pain scales will be done by nurses/nursing aids taking vitals.
|
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.
On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
|
Immediately post-operatively (upon arrival to PACU). These pain scales will be done by nurses/nursing aids taking vitals.
|
|
Patient reported pain
Time Frame: 4 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.
On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
|
4 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
|
Patient reported pain
Time Frame: 8 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.
On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
|
8 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
|
Patient reported pain
Time Frame: 12 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.
On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
|
12 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
|
Patient reported pain
Time Frame: 16 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.
On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
|
16 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
|
Patient reported pain
Time Frame: 20 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.
On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
|
20 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
|
Patient reported pain
Time Frame: 24 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10.
On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
|
24 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of stay
Time Frame: Day of surgery to day of discharge up to 30 days
|
Days spent in hospital including day of surgery
|
Day of surgery to day of discharge up to 30 days
|
|
Narcotic use
Time Frame: Starting with administration of opioid medication in PACU until time of discharge up to 30 days
|
We will measure the amount of opioid medication given to the patients.
|
Starting with administration of opioid medication in PACU until time of discharge up to 30 days
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Arthur Carlin, MD, Henry Ford Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 643256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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