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Clinical Trials/NCT03189693
NCT03189693
Unknown
Not Applicable

Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy

Makassed General Hospital1 site in 1 country60 target enrollmentJune 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Reduce Pain After Appendectomy
Sponsor
Makassed General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Analgesic consumption
Last Updated
4 years ago

Overview

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.

Detailed Description

Patients undergoing appendectomy will be randomly allocated into two equal groups using the sealed envelope technique. All patients will receive general anesthesia (GA). Patients in group I will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture, while patients in Group II will receive placebo. Paravertebral Block Technique Unilateral right side nerve stimulator-guided PVB is performed while patients are in the left lateral decubitis position. The appropriate levels for the PVB are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline. After aseptic preparation of the skin, 1 mL 1% lidocaine is infiltrated at the injection sites. A 21-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to maintain muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA. 4 mL of the local anaesthetic 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%.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
April 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Makassed General Hospital

Eligibility Criteria

Inclusion Criteria

  • Older than 18 years
  • Scheduled to undergo appendectomy

Exclusion Criteria

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

Outcomes

Primary Outcomes

Analgesic consumption

Time Frame: 24 hours postoperatively

The quantity of analgesics consumed will be recorded

Secondary Outcomes

  • hemodynamic stability measured through mean arterial pressure (MAP).(Approximately 1 hour)

Study Sites (1)

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