The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy (TOPBLOC)

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Phrenic nerve block with saline; Drug: Phrenic nerve block with Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02173418

S-20120129 (Other Identifier)

2012-002844-25 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients planned for elective lobectomy or pneumonectomy
2. 18 years or more on the day of the operation
3. Danish skills appropriate for fulfilling preoperative questionnaires

Exclusion criteria

1. Known contralateral paresis of the Phrenic nerve
2. Allergy to Ropivacaine or Sodium Chloride
3. Preoperative ipsilateral shoulder pain
4. Infection or eczema on the intervention site. Clinical decision
5. Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation
6. Pregnancy
7. Acute porphyria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Ropivacaine

Experimental group

Description:

Phrenic nerve block with Ropivacaine

Treatment:

Drug: Phrenic nerve block with Ropivacaine

Placebo

Placebo Comparator group

Description:

Phrenic nerve block with Sodium chloride

Treatment:

Drug: Phrenic nerve block with saline