Clinical trial NCT04003909: Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
Official title: Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation.

Detailed description: This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study.

All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group:

Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia.

Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block .

Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes.

Eligibility criteria: Inclusion Criteria:

* Patients aged from 40 to 65 years old
* Both sexes.
* ASA I-II.
* Undergo hip replacement surgery.
* Body mass index (BMI) from 18 to 35 kg/m2.

Exclusion Criteria:

* Patient refusal.
* Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. )
* BMI \> 35.
* Known allergy to local anesthetics.
* ASA III-IV.
* Patients with difficulty in evaluating their level of pain.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Visual analogue scale
timeFrame: 30 minutes,2,4, 6, 12, and 24 hours postoperative.
measure: Duration of analgesia
timeFrame: 24 hours postoperative
measure: Incidence of complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Anesthesia Department
Study officials:
affiliation: Cairo University
name: Ashraf Rady, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Amr abdelnasser
role: STUDY_DIRECTOR
References:
citation: Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
citation: Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.
citation: Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
citation: Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.