Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain.
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|ClinicalTrials.gov Identifier: NCT01597479|
Recruitment Status : Completed
First Posted : May 14, 2012
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Levobupivacaine||Phase 4|
We designed a prospective randomized controlled trial, with nursing blinded evaluation.
We enrolled 52 patients scheduled for elective ambulatory TRA. 2 patients were excluded after randomization. Patients were randomized into two groups:
A. Group A= no distal peripheral nerve blocks (no dPNBs group; n = 24 ): We performed usual anesthetic technique for surgery: an AXILLARY BRAQUIAL PLEXUS BLOCK using SHORT ACTING local anesthetic (mepivacaine 1%). Patients allocated in this group didn't received any additional intervention in the postoperative period.
B. Group B (dPNBs group; n = 26): We performed the same anesthetic technique for surgery (AXILLARY BLOCK with 1% of mepivacaine) with an additional intervention. Patients allocated in this group received postoperatively dPNBs on target nerves. Based on surgical approached and technique we evaluated that radial and median nerves were responsible for the innervation of the surgical area, and therefore responsible for the postoperative pain. We performed dPNBs ON RADIAL AND MEDIAN NERVES (TARGET NERVES) WITH LONG ACTING AND LOW CONCENTRATION LOCAL ANESTHETIC (0,125% levobupivacaine 5ml/nerve).
All blocks were performed under ultrasound guidance.
Analgesic regime prescribed at discharge was the same in both groups: dexketoprofen with tramadol for rescue analgesia.
The primary outcome was to evaluate the proportion of patients experienced moderate to severe pain during first and second day postoperatively, mesured using a numerical visual scale (NVS) of 0 to 10 (0= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3), moderate pain (NVS 7-10) and severe pain (NVS 7-10).
We considered dPNBs effective when patients experienced mild pain (NVS 0-3) for at least 6 hours after dPNBs puncture.
Secondary outcomes included:
- Maximum pain intensity during first and second day postoperatively.
- Duration of dPNBs, defined as the interval between dPNBs performance and the occurrence of first pain.
- Time to discharge, defined as the interval since patient arrived at postoperative care unit (PACU) until discharge home.
- Presence of distal hand motor block after dPNBs puncture.
- Needed for rescue analgesia and total consumption of tramadol during first and second day postoperatively
- Incidence of postoperative nausea and vomiting during 1st and 2nd day postoperatively
- Needed for rescue antiemetic therapy, total consumption of ondansetron and effectiveness of treatment during 1st and 2nd day postoperatively.
Patients were contacted by phone first and second day postoperatively from a blinded PACU nursing staff (all outcome data were collected by PACU nursing staff blinded to group allocation).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Distal Peripheral Nerve Blocks on Postoperative Pain Management After Ambulatory Thumb Resection Arthroplasty.|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
No Intervention: No dPNBs group
Patients in this group didn't receive any intervention in the postoperative period.
Experimental: dPNBs group
Patients in this group received ultrasound guided dPNBs on radial and median nerves (target nerves of TRA) in the postoperative period, before discharge.
The procedural objective of dPNBs was to place local anesthetic around the target nerves to achieve a long lasting, sensitive and selective block in the surgical area. dPNBs were performed with 5 ml/nerve of levobupivacaine 0,125%.
Ultrasound guidance allowed us to verify the correct distribution of LA around the target nerves target and optimize needle position if it was necessary, always avoiding the intraneural injection.
In dPNBs group, we performed ultrasound guided dPNBs on radial and median nerves using low concentration and low volume of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve). Using low concentrations of levobupivacaine on target nerves could achieve a prolonged sensitive block in the surgical area without motor block of the hand.
Other Name: long acting local anesthetics
- Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day [ Time Frame: Up to 48 hours ]Pain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.
- Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron [ Time Frame: Up to 48 hours ]Number of participants with Maximum pain intensity NVS > 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597479
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Principal Investigator:||Mireia Rodriguez, anesthesia||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|