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The effect of continuous infusion of bupivacaine via intra incisional catheter on reduction of pain intensity after surgery in spinal fixation surgery

Comparison the effect of continuous injection of bupivacaine via intra incisional catheter versus PCA morphine pump on reduction of postoperative pain intensity in thoracic and lumbar spine fixation surgury

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100127003213N7
Enrollment
30
Registered
2019-11-07
Start date
2019-11-21
Completion date
Unknown
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal surgery. Fusion of spine, thoracolumbar region

Interventions

Intervention 1: Intervention group:The surgeon puts a Intra incisional catheter(Infiltralong manufacturing company. Pajunk of Germany) before closing the surgical wound in the basement of the fascia.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients candidate for surgical fixation of the thoracic and lumbar spine (TLIF) The age range is 75-40 years (ASA = 1 or 2) The mental ability to collaborate in the study

Exclusion criteria

Exclusion criteria: Uncontrolled seizure Depression Localized surgical site infection Rupture and repair of dura, Severe coagulation disorder Abuse and drug dependence Drug Allergy Patients with psycho-somatic pains

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: If the patient is consciousness: every 15 minutes (15-30-45-60 minute intervals) pain will be assessed in the recovery room.During the first 6 hours, every hour, at the second 6 hours every 2 hours and at the 12 hours later every 4 hours, pain will be assessed in the ward. Method of measurement: Numeric Rating Scale (NRS).

Secondary

MeasureTime frame
First analgesic requirement based on minutes of the patient's presence in recovery room and ward. Timepoint: First analgesic requirement (based on minutes) after the patient's presence in recovery room every 15 minutes for an hour, and then in the ward every hour for 6 hours and then every 2 hours to 12 hours and then every 4 hours to 24 hours post operation. Method of measurement: Observation.;Total morphine consumption. Timepoint: Total morphine consumption during postoperative first 24 h. Method of measurement: Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Parvin

Shiraz University of Medical Sciences

v.parvin90@gmail.com+98 71 3647 4270

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026