Continuous TAP Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses

NCT02662023 | Completed Phase 4 Results

• 1 other identifier: TAP Basal vs. Bolus
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single-injection transversus abdominis plane (TAP) blocks have been used to treat postoperative pain, and are become very popular within the United States because of their high analgesic potency and relative ease of placement. Unfortunately, the longest local anesthetic available lasts only 8-12 hours. Continuous TAP blocks-also termed "perineural infusion"-involve bathing the multiple nerves of the abdominal wall in local anesthetic using a percutaneously-inserted perineural catheter inserted just anterior (ventral) and cephalad to the anterior superior iliac spine. For most catheter locations, an infusion is preferred to a single-injection nerve block because the duration of analgesia may be extended to better match the duration of surgical pain. But, unlike brachial plexus, femoral, and sciatic nerve perineural infusion, a continuous basal infusion of local anesthetic does not provide adequate analgesia for TAP catheters. This may be due to the fact that the TAP is a relatively tight space, so it might require a bolus of fluid to adequately spread the perineural local anesthetic to the multiple required nerves (as evidence of this, single-injection TAP blocks are very effective, although with a limited duration). The result is that while single-injection TAP blocks are widely used, TAP catheters have not been adopted. This scenario leaves surgical pain untreated following the resolution of the single-injection TAP block. The recent development of an infusion pump that can automatically deliver repeated bolus doses may allow the spread of local anesthetic to the multiple sensory nerves necessary to provide adequate analgesia, with a duration that better matches postoperative requirements. The investigators therefore propose a randomized, double-masked, controlled trial to determine if delivering local anesthetic as a repeated bolus dose results in improved local anesthetic spread/effects compared with a continuous basal infusion for TAP catheters.

Conditions

Postoperative Pain

Keywords

Healthy Human Volunteers

Outcome Measures

Primary Outcomes (1)

• Sensory Deficit (Cold Roller), Mid-axillary Line

  The distance of sensory deficit to cold measured in centimeters along the mid-axillary line. A cold roller is a device that looks like a paint application roller, but the roller itself is metal that can be brought to freezing. It is placed in the mid-axillary line and moved up and down until the sensory deficit to cold is revealed and subsequently measured.

  6 hours following the initiation of local anesthetic administration

Secondary Outcomes (4)

• Sensory Deficit (Cold Roller), Mid-axillary Line

  Hourly from Hours 0-5 following the initiation of local anesthetic administration

• Sensory Deficit (Cold Roller), Transverse Horizontal Line

  Hourly from Hours 0-6 following the initiation of local anesthetic administration

• Sensory Deficit (Von Frey Hairs), Transverse Horizontal Line

  Hourly from Hours 0-6 following the initiation of local anesthetic administration

• Sensory Deficit (Von Frey Hairs), Mid-axillary Line

  Hourly from Hours 0-6 following the initiation of local anesthetic administration

Study Arms (2)

RIGHT side BOLUS and left side basal

EXPERIMENTAL

Bilateral transversus abdominis catheters were inserted and ropivacaine 0.2% administered concurrently. For the right catheter, the ropivacaine was administered as two separate bolus doses of 24 mL each: one at time point zero and one 3 hours later. For the left catheter, the ropivacaine was administered as a continuous basal infusion (8 mL/h) from time point zero for the following 6 hours

Drug: Bolus; Drug: Basal

RIGHT side BASAL and left side bolus

ACTIVE COMPARATOR

Bilateral transversus abdominis catheters were inserted and ropivacaine 0.2% administered concurrently. For the right catheter, the ropivacaine was administered as a continuous basal infusion (8 mL/h) from time point zero for the following 6 hours. For the left catheter, the ropivacaine was administered as two separate bolus doses of 24 mL each: one at time point zero and one 3 hours later

Drug: Bolus; Drug: Basal

Interventions

Bolus DRUG

A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as two separate bolus doses of 24 mL each: one at time point zero and one 3 hours later.

Also known as: automatic intermittent bolus doses

RIGHT side BASAL and left side bolus; RIGHT side BOLUS and left side basal

Basal DRUG

A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for the following 6 hours.

Also known as: continuous basal infusion

RIGHT side BASAL and left side bolus; RIGHT side BOLUS and left side basal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers weighing more than 45 kg;
• must be willing to have bilateral transverses abdominis plane nerve block catheters be placed with subsequent ropivacaine administration and sensory testing for 6 hours

You may not qualify if:

• BMI greater than 40 (BMI=weight in kg/ \[height in meters\];
• regular opioid use within the previous 2 months;
• previous participation within the same study;
• allergy to study medications;
• known renal insufficiency (creatinine \> 1.5 mg/dL);
• pregnancy;
• incarceration; and
• any known neuro-muscular deficit of either abdominal wall.

Sponsors & Collaborators

• University of California, San Diego: lead
• Zyno Medical: collaborator
• Teleflex: collaborator

Study Sites (1)

Ucsd Ctri

La Jolla, California, 92097, United States

Location

Related Publications (6)

• Ilfeld BM. Continuous peripheral nerve blocks: a review of the published evidence. Anesth Analg. 2011 Oct;113(4):904-25. doi: 10.1213/ANE.0b013e3182285e01. Epub 2011 Aug 4.

  PMID: 21821511 BACKGROUND

• Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

  PMID: 20830871 BACKGROUND

• Stoving K, Rothe C, Rosenstock CV, Aasvang EK, Lundstrom LH, Lange KH. Cutaneous Sensory Block Area, Muscle-Relaxing Effect, and Block Duration of the Transversus Abdominis Plane Block: A Randomized, Blinded, and Placebo-Controlled Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):355-62. doi: 10.1097/AAP.0000000000000252.

  PMID: 25923818 BACKGROUND

• Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.

  PMID: 22476239 BACKGROUND

• Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.

  PMID: 21851346 BACKGROUND

• Khatibi B, Said ET, Sztain JF, Monahan AM, Gabriel RA, Furnish TJ, Tran JT, Donohue MC, Ilfeld BM. Continuous Transversus Abdominis Plane Nerve Blocks: Does Varying Local Anesthetic Delivery Method-Automatic Repeated Bolus Versus Continuous Basal Infusion-Influence the Extent of Sensation to Cold?: A Randomized, Triple-Masked, Crossover Study in Volunteers. Anesth Analg. 2017 Apr;124(4):1298-1303. doi: 10.1213/ANE.0000000000001939.

  PMID: 28319550 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

NOP-bolus regimen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Lack of surgical pain in the healthy volunteer subjects of this study. Since the subjects of this study were healthy pain-free volunteers, we used cutaneous cold and pressure deficits as surrogate outcome measures.

Results Point of Contact

• Title: Brian M. Ilfeld, MD, MS
• Organization: University of California, San Diego

bilfeld@ucsd.edu

Study Officials

• Brian Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only individual aware of the treatment group assignments is the investigational pharmacist who has no interaction with the study subjects. Treatment group assignments were released by the investigational pharmacy only after completion of data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: This is a split-body study in which each study subject receives both treatments: one on each side of the body. Which treatment is applied to which side of the body is randomized (and masked).

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)