Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.

NCT05592496

Postoperative Pain

UNKNOWN NA

Intraperitoneal Instillation of Levobupivacaine With Morphine Versus Levobupivacaine With Magnesium Sulfate for Postoperative Analgesia

NCT05281081

Post Operative Pain

COMPLETED PHASE4

Comparing Efficacy of Different Drugs Combinations for Serratus Anterior Block for Thoracotomy

NCT05565235

Post Operative Pain, Acute

UNKNOWN PHASE4

Efficacy of Rectal Sheath Analgesia After Midline Laparotomy

NCT02869841

Surgery Pain Postoperative

COMPLETED PHASE4

Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication Requirement

NCT03071991

Pain, Postoperative

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Port-sites infiltration:Bupivacaine0,25%

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.

Group Type EXPERIMENTAL

Port-sites infiltration:Bupivacaine0.25%

Intervention Type DRUG

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

Metamizole and Acetaminophen iv

Intervention Type DRUG

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

Epidural analgesia:Levobupivacaine0.125%

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.

Group Type EXPERIMENTAL

Epidural analgesia:Levobupivacaine0,125%

Intervention Type DRUG

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

Metamizole and Acetaminophen iv

Intervention Type DRUG

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

Metamizole and Acetaminophen iv

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

Group Type ACTIVE_COMPARATOR

Metamizole and Acetaminophen iv

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Port-sites infiltration:Bupivacaine0.25%

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

Intervention Type DRUG

Epidural analgesia:Levobupivacaine0,125%

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

Intervention Type DRUG

Metamizole and Acetaminophen iv

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Port-sites infiltration with bupivacaine Epidural analgesia Analgesia iv

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No