The effect of lateral pectoral nerve block in combination with interscalene nerve block on opioid consumption and pain on awake shoulder arthroscopy patients

The effect of lateral pectoral nerve block in combination with interscalene nerve block on opioid consumption and pain on awake shoulder arthroscopy patients - A feasibility study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000093-25-DK

Enrollment

Registered

2022-01-31

Start date

2022-05-05

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Peri- and postoperative pain after shoulder arthroscopy MedDRA version: 20.0 Level: LLT Classification code 10077421 Term: Shoulder arthroscopy System Organ Class: 100000004848

Interventions

Trade Name: Marcain-Adrenalin Product Name: Marcain-Adrenalin Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: Bupivacaine CAS Number: 2180-92-9 Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Set for elective shoulder arthroscopy by one single orthopedic surgeon • Planned acromioclavikular decompression • Planned awake surgery anesthetized by an interscalene nerve block • ASA I-III • Patient = 18 years • Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: • Inability to cooperate • Unable to speak and/or understand danish or other types of communication problems • Other major planned operative procedures planned during this operation (Bankart, cuff-operations etc.) • Allergy to local analgesics in the study (Marcain + adrenaline) • Lack of tolerance of Fentanyl • Chronic pain with daily opioid consumption (dosed > x 1 day) • Chronic pain treated with gabapentin, pregabalin, tricyclic antidepressants, opioid antagonists or SNRI • Treatment with antipsychotics • The patient is unsuitable for awake surgery • Known abuse of alcohol, drugs or medicine • Previous shoulder surgery on the planned side for this shoulder arthroscopy • Previous participation in this study • Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this trial is to asses the effect of preoperative placed active or placebo lateral pectoral nerve block in combination with active interscalene nerve block on awake patients during shoulder arthroscopy. The primary objective of the study is to investigate perioperative opioid consumption ;Secondary Objective: The secondary objective is to investigate the quality of the anaesthesia according to the orthopedic surgeon;Primary end point(s): • Opioidconsumption perioperative during awake ambulatory awake shoulder arthroscopy on patients anesthetized with an interscalene nerve block with active or placebo lateral pectoral nerve block;Timepoint(s) of evaluation of this end point: Perioperatively	—

Measure

Time frame

Main Objective: The purpose of this trial is to asses the effect of preoperative placed active or placebo lateral pectoral nerve block in combination with active interscalene nerve block on awake patients during shoulder arthroscopy. The primary objective of the study is to investigate perioperative opioid consumption ;Secondary Objective: The secondary objective is to investigate the quality of the anaesthesia according to the orthopedic surgeon;Primary end point(s): • Opioidconsumption perioperative during awake ambulatory awake shoulder arthroscopy on patients anesthetized with an interscalene nerve block with active or placebo lateral pectoral nerve block;Timepoint(s) of evaluation of this end point: Perioperatively

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Secondary

Measure	Time frame
Secondary end point(s): • Orthopaedic surgeon evaluation of anaesthesia (good/medium/poor) • Patient-Experienced pain score perioperatively (NRS 0-10, where 0 is no pain and 10 the worst possible pain) • Total number of injections and consumption of opioid (Fentanyl) perioperatively • Need for additional local anaesthetics injected in the AC joint by the orthopaedic surgeon peroperatively • Total morphine consumption in PACU • The force of the Pectoral muscles on the planned operated upper limb is tested with a dynamometer before the lateral pectoral nerve blockade is placed and again 20-30 minutes after and before the placing of the interscalene nerve block.;Timepoint(s) of evaluation of this end point: Assessed perioperatively and postoperative in PACU	—

Measure

Time frame

Secondary end point(s): • Orthopaedic surgeon evaluation of anaesthesia (good/medium/poor) • Patient-Experienced pain score perioperatively (NRS 0-10, where 0 is no pain and 10 the worst possible pain) • Total number of injections and consumption of opioid (Fentanyl) perioperatively • Need for additional local anaesthetics injected in the AC joint by the orthopaedic surgeon peroperatively • Total morphine consumption in PACU • The force of the Pectoral muscles on the planned operated upper limb is tested with a dynamometer before the lateral pectoral nerve blockade is placed and again 20-30 minutes after and before the placing of the interscalene nerve block.;Timepoint(s) of evaluation of this end point: Assessed perioperatively and postoperative in PACU

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Countries

Denmark

Contacts

Public ContactThomas Fichtner Bendtsen

Aarhus University Hospital

tfb@dadlnet.dk+4551542997

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026