Trial Outcomes & Findings for Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain. (NCT NCT01597479)

Last Updated: 2016-03-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

Up to 48 hours

Results posted on

2016-03-21

Participant Flow

Between february 2010 and april 2014, we enrolled 52 patients scheduled for elective ambulatory TRA under rutine axillary braquial plexus block.

Participant milestones

Participant milestones
Measure	Distal Peripheral Nerve Blocks Group (dPNBs Group) In dPNBs group, we practice distal peripheral nerves blocks guided by ultrasound and neurostimulator. Levobupivacaine: In dPNBs group, we practice ultrasound guided distal peripheral nerve blocks on radial and median nerves using low volume and low concentration of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve). We performed dPNBs in the postoperative period. Deffered dPNBs under the influence of axillary block didn't cause patient disconfort. We considered the technique safety due to ultrasound guidance.	No Intervention (no dPNBs Group) In patients of no dPNBs group didn't performed any intervention after surgery.
Overall Study STARTED	26	26
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Distal Peripheral Nerve Blocks Group (dPNBs Group) In dPNBs group, we practice distal peripheral nerves blocks guided by ultrasound and neurostimulator. Levobupivacaine: In dPNBs group, we practice ultrasound guided distal peripheral nerve blocks on radial and median nerves using low volume and low concentration of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve). We performed dPNBs in the postoperative period. Deffered dPNBs under the influence of axillary block didn't cause patient disconfort. We considered the technique safety due to ultrasound guidance.	No Intervention (no dPNBs Group) In patients of no dPNBs group didn't performed any intervention after surgery.
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Ultrasound Guided Distal Peripheral Nerve Blocks and Postoperative Pain.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	dPNBs Group n=24 Participants dPNBs on radial and median nerves at the elbow in postoperative period, before discharge	Non dPNBs Group n=26 Participants Non intervention in postoperative period	Total n=50 Participants Total of all reporting groups
Age, Continuous years	67.4 years STANDARD_DEVIATION 6.5 • n=5 Participants	64.2 years STANDARD_DEVIATION 7.5 • n=7 Participants	65.7 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Spain	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 48 hours

Population: Patients undergoing ambulatory thumb resection arthroplasty (TRA)

Outcome measures

Outcome measures
Measure	Distal Peripheral Nerve Blocks Group (dPNBs Group) n=24 Participants We practiced ultrasound guided dPNBs on radial and median nerves, after surgery, before discharge. * Distal median nerve block was performed at the elbow, in the internal bicipital channel. * Distal radial nerve block was performed at approximately the junction of the middle and distal thirds of the arm. We use 5ml per nerve of levobupivacaine 0,125% for target nerve blocks.	Non Distal Peripheral Nerve Blocks (Non dPNBs Group) n=26 Participants Patients in non dPNBs didn't received any intervention in the postoperatively period.
Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day Pain intensity NVS>3 on call 24h	8.3 percentage of patients	80.8 percentage of patients
Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day Pain intensity NVS>3 on call 48h	4.2 percentage of patients	42.3 percentage of patients

SECONDARY outcome

Timeframe: Up to 48 hours

Population: Patients undergoing ambulatory thumb resection arthroplasty

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).

Outcome measures

Outcome measures
Measure	Distal Peripheral Nerve Blocks Group (dPNBs Group) n=24 Participants We practiced ultrasound guided dPNBs on radial and median nerves, after surgery, before discharge. * Distal median nerve block was performed at the elbow, in the internal bicipital channel. * Distal radial nerve block was performed at approximately the junction of the middle and distal thirds of the arm. We use 5ml per nerve of levobupivacaine 0,125% for target nerve blocks.	Non Distal Peripheral Nerve Blocks (Non dPNBs Group) n=26 Participants Patients in non dPNBs didn't received any intervention in the postoperatively period.
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Rescue analgesia 24h (n)	2 participants	17 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Maximum pain intensity 24h (NVS>3)	8 participants	24 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Maximum pain intensity 48h (NVS >3)	5 participants	21 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Rescue Analgesia 48h (n)	5 participants	17 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Nausea and vomiting 24h (n)	1 participants	10 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Nausea and vomiting 48h (n)	0 participants	5 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Use of ondansetron 24h (n)	1 participants	5 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Use of ondansetron 48h (n)	0 participants	5 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Effectiveness of ondansetron 24h	1 participants	4 participants
Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron Efectiveness of ondansetron 48h	0 participants	2 participants

Adverse Events

Distal Peripheral Nerve Block Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dra. Mireia Rodriguez Prieto

Hospital de la Santa Creu i Sant Pau

Phone: 677896054

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place