NCT03469700

Brief Summary

The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity. We will be discussing the effect of adding paravertebral block (PVB) in addition to general anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

March 3, 2018

Last Update Submit

September 26, 2019

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    The primary aim is to compare the effect of paravertebral block with general anesthesia versus general anesthesia alone on postoperative pain after laparoscopic sleeve gastrectomy surgeries. Pain will be assessed using the Visual Analogue scale (VAS) with a score of 0 denoting no pain and 10 maximum possible pain.

    within 1 week postoperatively

Secondary Outcomes (1)

  • ambulation

    within 1 week postoperatively

Study Arms (2)

GA+PVB

EXPERIMENTAL

Patients will receive general anesthesia with paravertebral block

Other: general anesthesiaOther: Paravertebral block

GA+placebo PVB

ACTIVE COMPARATOR

Patients will receive general anesthesia with placebo block

Other: general anesthesiaOther: Placebo PVB

Interventions

general anesthesiaOTHER

Induction of general anesthesia will be performed followed by endotracheal intubation. General anesthesia is induced with 0.5-1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.6 mg/kg/h rocuronium, 60% nitrous oxide and 40% oxygen with Ultiva (Remifentanyl) 0.1-0.2 μg/kg/hr

GA+PVBGA+placebo PVB
Paravertebral blockOTHER

Bilateral paravertebral block guided by a nerve stimulator will be performed by injecting local anesthetic mixture from levels T11 to T6. Each 20 ml of the mixture will contain: 6 ml lidocaine 2%; 6 ml lidocaine 2% with adrenaline 5 μg /ml; 5 ml bupivacaine 0.5%; 50μg fentanyl (1 ml); and 2 ml saline 0.9%

GA+PVB
Placebo PVBOTHER

Placebo bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.

GA+placebo PVB

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with body mass index (BMI) greater than or equal to 30
  • American Society of Anesthesiologist (ASA) score greater than or equal to 2
  • Undergoing laparoscopic gastric sleeve surgeries

You may not qualify if:

  • Patients with ASA score less than 2 and greater than 4
  • Patients with any type of allergy to local anesthesia
  • Patients refusing to be part of the study (refusal to sign consent)
  • Any complication during surgery or anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Saleh Kanawati, MD

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh Kanawati, MD

CONTACT

+9611636000s.kanawati@hotmail.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
Anesthesiologist

Study Record Dates

First Submitted

March 3, 2018

First Posted

March 19, 2018

Study Start

March 15, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

LE(1)