Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

Postoperative Pain Clinical Trial

Official title:

Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003909
• Other study ID #: N-147-2018
• Status: Completed
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: November 6, 2019

Study information

• Verified date: November 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 6, 2019
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• ultrasound-guided Erector spinae plane block
The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
• subarachonoid block
Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10µg of fentanyl will be injected for 30 seconds.

Locations

Country	Name	City	State
Egypt	Anesthesia Department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Bassant M. Abdelhamid

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Ueshima H, Otake H. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.	24 hours postoperative
Secondary	Visual analogue scale	Visual analogue scale at the following intervals:30 minutes,2,4, 6, 12, and 24 hours postoperative.	30 minutes,2,4, 6, 12, and 24 hours postoperative.
Secondary	Duration of analgesia	defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic in the form of iv morphine	24 hours postoperative
Secondary	Incidence of complications	Nerve injury, Hematoma formation, LA toxicity, Intravascular injection.	24 hours