NCT03189693

Brief Summary

Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to examine the analgesic effect of PVB on appendectomy in adult patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

4.8 years

First QC Date

June 13, 2017

Last Update Submit

January 14, 2022

Conditions

Reduce Pain After Appendectomy

Outcome Measures

Primary Outcomes (1)

  • Analgesic consumption

    The quantity of analgesics consumed will be recorded

    24 hours postoperatively

Secondary Outcomes (1)

  • hemodynamic stability measured through mean arterial pressure (MAP).

    Approximately 1 hour

Study Arms (2)

PVB group

EXPERIMENTAL

Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture

Other: PVBOther: GAOther: Anesthetic injections

Placebo

PLACEBO COMPARATOR

Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2

Other: PlaceboOther: GA

Interventions

PVBOTHER

nerve stimulator-guided PVB will be performed at two levels

PVB group
PlaceboOTHER

nerve stimulator-guided PVB containing placebo will be performed at two levels

Placebo
GAOTHER

All patients will receive general anesthesia.

PVB groupPlacebo
Anesthetic injectionsOTHER

4 mL of the local anesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.

PVB group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years
  • Scheduled to undergo appendectomy

You may not qualify if:

  • cardiac disease,
  • developmental delay,
  • neurologic deficit,
  • allergies to any of the drugs routinely used in anesthesia management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

Central Study Contacts

Zoher Naja, MD

CONTACT

+9611636000zouhnaja@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson of Anesthesia and Pain Management Department

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 16, 2017

Study Start

June 1, 2017

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

LE(1)