Brachial Plexus Blockade Two Days Before Surgery Can Improve Postoperative Analgesia
Study Details
Study Description
Brief Summary
Intense e recurrent nociceptive stimulation, which occurs in the postoperatively, can trigger sensitization of the peripheral and central nociceptive pathway, leading to chronic pain. Patients with rotator cuff injury often present to surgery due to referred moderate to intense long-term pain. During the immediate postoperative period, pain is rare due to the routine administration of a brachial plexus blockade as an adjuvant to improve the quality of postoperative analgesia. However, after the second postoperative day, the effect of the blockade ceases, and the pain becomes high and hard to treat, leading the patient to request administration of more frequent and more potent analgesics. The aim of this project is to assess the postoperative analgesic benefits of a brachial plexus blockcade 2 days before arthroscopic surgical correction of rotator cuff injury by reducing the sensitization of the nociceptive pathway.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Intense e recurrent nociceptive stimulation, which occurs in the postoperatively, can trigger sensitization of the peripheral and central nociceptive pathway, leading to chronic pain. Patients with rotator cuff injury often present to surgery due to referred moderate to intense long-term pain. During the immediate postoperative period, pain is rare due to the routine administration of a brachial plexus blockade as an adjuvant to improve the quality of postoperative analgesia. However, after the second postoperative day, the effect of the blockade ceases, and the pain becomes high and hard to treat, leading the patient to request administration of more frequent and more potent analgesics. The aim of this project is to assess the postoperative analgesic benefits of a brachial plexus blockcade 2 days before arthroscopic surgical correction of rotator cuff injury by reducing the sensitization of the nociceptive pathway.
A sample of 70 participants will be recruited from a population of patients scheduled for arthroscopic correction of rotator cuff injury. The participants will be electronically divided into two groups: the regular group (RG) and the preemptive group (PG). Every patient in both groups will be taught about the numeric rating scale (NRS-11). The professional conducting the electronic randomization will not participate in any other step of the trial, and will keep the result of the lottery in secret. Every patient of both groups will undergo brachial plexus blockade and sedation right before surgery. The patients from PG will undergo brachial plexus blockade 2 days before surgery, and the RG will undergo ultrasound examination of the brachial plexus in the attempt to keep the patient blind to the group. Every patient in both groups will be advised to keep the arm in sling after the procedure 2 days before surgery (brachial plexus blockade in PG, and ultrasound in RG).
Seventy eligible patients on the day of their pre-anesthetic evaluation (see inclusion and exclusion criteria) will be invited to answer the Brief Pain Inventory validated to Brazilian patients, the Brazilian-Portuguese versions of the McGill Pain Questionnaire and the brief World Health Organization Quality of Life Assessment (WHOQOL-bref) validated to Brazilian-Portuguese (WHOQOL - SRPB). The samples will be electronically randomized into two groups: the regular group (RG) and the preemptive group (PG). Two days before the surgery, patients from both groups will arrive at the hospital. The patients from RG group will undergo ultrasound of the brachial plexus, while the patients from PG group will undergo brachial plexus blockade. In order to keep them blinded to the group, all of the patients will leave the hospital with their arms in a sling. Following this procedure and after surgery, the patient will be prescribed dipyrone 1 g every 6 h, and the drug combination acetaminophen (500 mg) with codeine (30 mg), as a rescue medication for pain > 3 (0 to 10). On the day of surgery, patients from each group will be questioned about their pain score and will undergo brachial plexus blockade and sedation immediately before the surgery. The pain score will be recorded immediately before the surgery, 6 h after the surgery, and at 6 p.m. on the first three postoperative days. On the third postoperative day, the patients will again respond to the Brief Pain Inventory validated to Brazilian patients, the Brazilian-Portuguese versions of the McGill Pain Questionnaire and the brief World Health Organization Quality of Life Assessment (WHOQOL-bref) validated to Brazilian-Portuguese (WHOQOL - SRPB).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Regular group Patients from this group will undergo only ultrasound examination of the brachial plexus, two days before the surgery. On the day of surgery they will undergo ultrasound-guided brachial plexus blockade (interscale access; 15 ml 0.5% levobupivacaine with adrenaline 1:200,000 plus 5 ml 2% lidocaine with adrenaline 1:200,000) and sedation ( midazolam 3 mg, fentanyl 50 µg and dexmedetomidine 1 µg/kg (infusion lasting 10 min) followed by 0.5 µg/kg/min). |
Drug: Regular group
Ultrasound examination of the brachial plexus 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.
Other Names:
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| Experimental: Preemptive group Patients from this group will undergo ultrasound-guided brachial plexus blockade, two days before the surgery. On the day of surgery they will undergo ultrasound-guided brachial plexus blockade (interscale access; 15 ml 0.5% levobupivacaine with adrenaline 1:200,000 plus 5 ml 2% lidocaine with adrenaline 1:200,000) and sedation ( midazolam 3 mg, fentanyl 50 µg and dexmedetomidine 1 µg/kg (infusion lasting 10 min) followed by 0.5 µg/kg/min). |
Drug: Preemptive group
Ultrasound guided brachial plexus blockade 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Pain score on third postoperative day [Three days]
Pain assessment through verbal numerical scale of pain (from 0 to 10).
Secondary Outcome Measures
- Pain scores before surgery. [Just before surgery]
Postoperative pain through verbal numerical scale of pain (from 0 to 10)
- Pain cores on three postoperative days. [Three days.]
Postoperative pain through verbal numerical scale os pain (from 0 to 10)
- Opioid consumption [Two days before surgery]
Opioid consumption (mg codeine) two days before surgery
- Opioid consumption [Three days]
Opioid consumption (mg codeine) during the first three postoperative days
Eligibility Criteria
Criteria
Inclusion Criteria:
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Body mass index < 35 kg/m²
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shoulder pain lasting > 3 months
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pain score > 3 (visual analog scale and verbal response 0 to 10) on the day of pre anesthetic evaluation
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American Society of Anesthesiologists score I or II
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mentally and legally capable to understand and consent to study participation.
Exclusion Criteria:
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Allergy to any medication of the trial
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refusal to participate, contraindication to any medication or technique described in the protocol of the trial
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complications from, or failure of brachial plexus blockade.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | Brazil | 01246-903 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
- Principal Investigator: Joaquim Vieira, Professor, University of Sao Paulo School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAAE 09012419.3.0000.5501