Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter

NCT04787367 | Completed

• 1 other identifier: 643256
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Pain, Postoperative

Keywords

TAP block; Obesity; Sleeve gastrectomy; Bariatrics; Post-operative pain

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Length of stay

  Day of surgery to day of discharge up to 30 days

• Narcotic use

  Starting with administration of opioid medication in PACU until time of discharge up to 30 days

Study Arms (2)

Early-operative TAP block

EXPERIMENTAL

The TAP block will be administered after the placement of the camera port.

Procedure: TAP block

Late-operative TAP block

EXPERIMENTAL

The TAP block will be administered at the completion of the case just before removing the camera port.

Procedure: TAP block

Interventions

TAP block PROCEDURE

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.

Early-operative TAP block; Late-operative TAP block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing laparoscopic sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarah Diaz: lead

Study Sites (1)

Henry Ford Macomb Hospital

Clinton Township, Michigan, 48038, United States

Location

MeSH Terms

Conditions

Obesity; Pain, Postoperative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• Arthur Carlin, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be unaware of when they received the block. The nursing assistants checking the pain score will also be unaware of the timing of the block.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sub-Investigator

Model Details: This is a single blinded, prospective study designed to determine optimal timing of TAP block in laparoscopic gastric sleeve patients. Patients will randomly be assigned to the early intra-operative TAP block group or the late intra-operative TAP block group.

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: March 8, 2021
• Study Start: February 12, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)