NCT02662660

Brief Summary

A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for phase_3 postoperative-pain

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3 postoperative-pain

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

3.9 years

First QC Date

January 17, 2016

Last Update Submit

January 20, 2016

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain measured by Visual Analogic Scale

    Postoperative pain will be measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) 24 hours after surgery,

    24 hours after surgery

Study Arms (3)

Port-sites infiltration:Bupivacaine0,25%

EXPERIMENTAL

Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Drug: Port-sites infiltration:Bupivacaine0.25%Drug: Metamizole and Acetaminophen iv

Epidural analgesia:Levobupivacaine0.125%

EXPERIMENTAL

Epidural analgesia consists in the placement of a thoracic epidural catheter inserted at the level T6-T7 and administration of a continuous perfusion of Levobupivacaine 0.125% 6ml/h. Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Drug: Epidural analgesia:Levobupivacaine0,125%Drug: Metamizole and Acetaminophen iv

Metamizole and Acetaminophen iv

ACTIVE COMPARATOR

Associated intravenous analgesia will include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Drug: Metamizole and Acetaminophen iv

Interventions

Port-sites infiltration:Bupivacaine0.25%DRUG

Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.

Also known as: Port-sites infiltration with bupivacaine
Port-sites infiltration:Bupivacaine0,25%
Epidural analgesia:Levobupivacaine0,125%DRUG

Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.

Also known as: Epidural analgesia
Epidural analgesia:Levobupivacaine0.125%
Metamizole and Acetaminophen ivDRUG

Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.

Also known as: Analgesia iv
Epidural analgesia:Levobupivacaine0.125%Metamizole and Acetaminophen ivPort-sites infiltration:Bupivacaine0,25%

Eligibility Criteria

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

You may qualify if:

  • body mass index (BMI) \>40 Kg/m2
  • BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity

You may not qualify if:

  • patients undergoing other bariatric techniques
  • severe underlying cardiovascular diseases
  • chronic renal failure
  • hepatic dysfunction
  • previous foregut surgery
  • patients with any contraindication for bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.

    PMID: 27177956DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineAnalgesia, EpiduralDipyrone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnalgesiaAnesthesia and AnalgesiaAminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Manuel Duran, MD, PhD

    Hospital General Elche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 17, 2016

First Posted

January 25, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share