Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter

The goal of this study is to investigate whether an early intraoperative transverse abdominis plane block (TAP block) will provide superior analgesia to a late intraoperative TAP block. A fixed amount of bupivacaine will be used for the TAP block and the primary outcomes will be measured by patient reported numerical assessment scores for pain.

Study Overview

• Status: Completed
• Conditions: Obesity; Pain, Postoperative
• Intervention / Treatment: Procedure: TAP block

Detailed Description

This is a single blinded, prospective study designed to determine optimal timing of transverse abdominis plane block (TAP block) in laparoscopic gastric sleeve patients. Research has shown that administration of TAP block during these cases does show improved post-operative pain control. There are no trials specifically evaluating the timing of administration in regards to superiority of pain control. To the investigators knowledge, no prospective study has ever been done investigating whether TAP block performed at the beginning of the case versus at the end of the case makes a difference in the amount of relief experienced by the patient. the investigators hypothesize that early intra-operative block will be superior to late intra-operative block in both post-operative pain as well as decreased length of stay in hospital secondary to reduction in peripheral and central nervous system hyper excitability. Before beginning the research study, ~200 plain envelopes will be made each containing one option written on paper indicating early intra-operative or late intra-operative TAP block. There will be equal numbers of both options. It will be the responsibility of either the PI or sub-investigators to select a random envelope and bring it to the operating room at the time of surgery. All patients involved in the study will have given informed consent in the office prior to surgery. On the day of surgery after the patient is induced and intubated, the PI or sub-investigator will open the envelope revealing the timing of the TAP block. Depending on what is revealed from the envelope, the patient will either receive the early intra-operative TAP block or the late intra-operative TAP block. The TAP block will be performed using 60 ml for right sided TAP block (side of specimen extraction) and 30 ml for left sided TAP block (non extraction side). 30 ml of bupivicaine solution will also be used for intraperitoneal irrigation as is already routinely done during these cases by the primary surgeon for additional analgesia. This will be performed at the conclusion of all cases regardless of which arm the patient is in. For the early intra-operative TAP block, optiview trocar entrance will be performed in the upper abdomen followed by CO2 insufflation. After introduction of the camera into this trocar, the right lateral abdominal wall will be visualized with the laparoscope. 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. The late post-operative block will be performed in the same fashion but after completion of the surgery just prior to removing the trocars and desufflation. The intraperitoneal irrigation with 0.25% bupivicaine solution will be performed at the end of the case using 30 ml total sprayed above the stomach, under the diaphragm, and over the bed of the spleen. All other medications intra-op and post-op including anesthesia will remain standardized according to the current HF Macomb bariatrics protocols. The data collection will take place immediately post-op, 4, 8, 12, 16, 20, and 24 hours post-op using the numerical assessment score (NAS) for pain which will be performed at the time vitals are taken by the nursing aids. The investigators will also be analyzing post-operative vomiting and length of stay in hours.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Henry Ford Macomb Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early-operative TAP block; The TAP block will be administered after the placement of the camera port.	Procedure: TAP block; 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.	Procedure: TAP block; 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

Outcome Measure	Measure Description	Time Frame
Patient reported pain	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Length of stay	Days spent in hospital including day of surgery	Day of surgery to day of discharge up to 30 days
Narcotic use	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: Sarah Diaz
• Investigators: Principal Investigator: Arthur Carlin, MD, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Post-operative pain; Sleeve gastrectomy; TAP block; Bariatrics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 643256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No