Paravertebral Block for Pain Management After Appendectomy

Sponsor
Makassed General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03189693
Collaborator
(none)
60
1
2
58
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PVB
  • Other: Placebo
  • Other: GA
  • Other: Anesthetic injections
N/A

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%.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy
Actual Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PVB group

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

Other: PVB
nerve stimulator-guided PVB will be performed at two levels

Other: GA
All patients will receive general anesthesia.

Other: Anesthetic injections
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%.

Placebo Comparator: Placebo

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

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

Other: GA
All patients will receive general anesthesia.

Outcome Measures

Primary Outcome Measures

  1. Analgesic consumption [24 hours postoperatively]

    The quantity of analgesics consumed will be recorded

Secondary Outcome Measures

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

    Intraoperative hemodynamic stability measured through mean arterial pressure (MAP)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Makassed General Hospital Beirut Lebanon

Sponsors and Collaborators

  • Makassed General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier:
NCT03189693
Other Study ID Numbers:
  • 212006
First Posted:
Jun 16, 2017
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022