The use of pectoral nerve block type II in patients undergoing trans-axillary thoracic outlet decompression.

The use of pectoral nerve block type II in patients undergoing trans-axillary thoracic outlet decompression. - BLOCKTOS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49807

Enrollment

Registered

2020-04-22

Start date

2020-08-27

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pectoral minor syndrome Thoracic inlet syndrome

Interventions

Standard treatment: Patients are admitted to the ward and given a pre-emptive dose of paracetamol as part of the perioperative pain management. Upon arrival into the operating theatre, all patients

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with NTOS - Selected for a trans-axillary thoracic outlet decompression (TATOD) by the TOS multidisciplinary workgroup. - Fit for surgery, defined as ASA (American Society of Anesthesiologists) Classification of I, II or III. - 18 years of age or older - Sufficient in speaking and writing the Dutch language - Normal liver and renal function - Informed consent

Exclusion criteria

Exclusion criteria: - Patients with a history of TOD (Redo-surgery) - Patients with ATOS or VTOS - ASA * 4 - Kidney or liver failure with contra-indication for NSAID or paracetamol - Mental retardation - Pregnancy - Patients with chronic strong opioid use (>3 administrations per week or continuous transdermal therapie, longer than the last 3 months) - Allergy to one or more medications used in the study including, ropivacaine, dexamethasone, propofol, sufentanil, succinylcholine, paracetamol, NSAID, morphine, granisetron

Design outcomes

Primary

Measure	Time frame
Primary Objective: The primary objective of this trial is to determine the effect of a PECS II block in trans-axillary thoracic outlet decompression (TATOD) on postoperative pain compared with standard treatment (paracetamol, NSAID and opioid*s) for patients diagnosed with neurogenic thoracic outlet syndrome (NTOS). Pain is measured using the Numeric Rated Scale (NRS) for pain. This is a psychometric response scale in which patients are asked to rate their pain from 0 to 10 (no pain to extreme pain). This scale is a validated and generally accepted tool to measure pain. Opioid use is measured in Morphine Equivalent Dose (MED). This is a generally accepted tool to quantify opioid use in patients. We will focus on the total opioid consumption on the PACU and on the ward during the first 6 and 24 hrs postoperatively.	—

Measure

Time frame

Primary Objective: The primary objective of this trial is to determine the effect of a PECS II block in trans-axillary thoracic outlet decompression (TATOD) on postoperative pain compared with standard treatment (paracetamol, NSAID and opioid*s) for patients diagnosed with neurogenic thoracic outlet syndrome (NTOS). Pain is measured using the Numeric Rated Scale (NRS) for pain. This is a psychometric response scale in which patients are asked to rate their pain from 0 to 10 (no pain to extreme pain). This scale is a validated and generally accepted tool to measure pain. Opioid use is measured in Morphine Equivalent Dose (MED). This is a generally accepted tool to quantify opioid use in patients. We will focus on the total opioid consumption on the PACU and on the ward during the first 6 and 24 hrs postoperatively.

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Secondary

Measure	Time frame
Secondary Objective(s): A secondary objective is to determine the effect of a PECS II block in TATOD on postoperative nausea and vomitus (PONV) and other opioid induced side-effects such as drowsiness, respiratory depression and urinary retention compared with standard treatment (paracetamol, NSAID and opioids) for patients diagnosed with NTOS. At last, we will determine the effect of a PECS II block in TATOD on the Quality of Recovery scale (QoR-15) compared with standard treatment (paracetamol, NSAID and opioids) for patients diagnosed with NTOS. The QoR-15 is a recently developed patient-reported outcome measurement (PROM) of postoperative quality of recovery. [26]	—

Measure

Time frame

Secondary Objective(s): A secondary objective is to determine the effect of a PECS II block in TATOD on postoperative nausea and vomitus (PONV) and other opioid induced side-effects such as drowsiness, respiratory depression and urinary retention compared with standard treatment (paracetamol, NSAID and opioid*s) for patients diagnosed with NTOS. At last, we will determine the effect of a PECS II block in TATOD on the Quality of Recovery scale (QoR-15) compared with standard treatment (paracetamol, NSAID and opioid*s) for patients diagnosed with NTOS. The QoR-15 is a recently developed patient-reported outcome measurement (PROM) of postoperative quality of recovery. [26]

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)