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USG Guided ESP Block in Spinal Surgery

Effect of USG Guided ESP Block in Spinal Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04148729
Enrollment
40
Registered
2019-11-01
Start date
2019-05-20
Completion date
2020-12-20
Last updated
2022-06-22

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

Conditions

Postoperative Pain

Keywords

erector spinae plane block, postoperative analgesia, spinal surgery

Brief summary

American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients which underwent lumbar spinal surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the all patient under general anaesthesia. 15 ml bupivacaine %0.5 and 5 ml lidocaine %2 will use for USG guided ESP block. 0.1 microgram/kg morphine will apply intravenously and diclofenac Na 75 mg intramuscularly will apply at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain assessment will perform with visual analog scale (VAS)

Detailed description

American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients which underwent lumbar spinal surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the 20 patients under general anaesthesia in Group E and same volume saline will apply to the ESP block region at T10 level for control group (Group C). Total intravenous anaesthesia (propofol+remifentanil) will perform to the all patients. 15 ml bupivacaine %0.5 and 5 ml lidocaine %2 will use for USG guided ESP block. 0.1 microgram/kg morphine intravenously and diclofenac Na 75 mg intramuscularly will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain assessment will perform with visual analog scale (VAS). VAS, morphine consumption and complications will record. The rescue analgesic 0.4 mg/kg mepheridine will administer intravenously whenever the patient requested to the analgesic. Diclofenac sodium 75 mg will repeat to the all patients at the 12th of postoperative period, intramuscularly.

Interventions

DRUGESP block

Ultrasound guided ESP block will perform with 15 ml bupivacaine+ 5 ml lidocaine at the T10 level bilaterally. 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly will perform for postoperative analgesia.

DRUGControl Group

In this group Ultrasound guided ESP block will not perform. Postoperative analgesia will provide with 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Both participants and anaesthesia providers will not know contain of the syringe.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* accepting to participate the study * ASA I-II patients * The patients underwent spinal surgery

Exclusion criteria

* Non Volunteers * ASA III and over * Renal and hepatic failure * Emergency surgical procedures

Design outcomes

Primary

MeasureTime frameDescription
11-point numerical rating scale score (NRS score)up the postoperative 24th hours.Postoperative pain assessment will perform with 11-point numerical rating scale score and numerical scale point which described by resident will record. Higher points show that severe pain. 0 point shows no pain.10 point shows unbearable pain.

Secondary

MeasureTime frameDescription
Postoperative analgesic requirementup the postoperative 24th hours.When the higher points numerical scale point (4\<) observed, additional analgesics will apply. An than, totally consumption of rescue analgesic requirement (meperidine consumotion) will calculate.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026