EFFECT OF SACRAL ERECTOR SPINA PLAN BLOCK ON TOTAL HIP ARTHROPLASTY

Postoperative Pain Clinical Trial

Official title:

EFFECT OF SACRAL ERECTOR SPINA PLAN BLOCK ON RECOVERY QUALITY AFTER TOTAL HIP ARTHROPLASTY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06221319
• Other study ID #: total hip arthroplasty
• Status: Completed
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Konya City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total hip arthroplasty (THA) is a surgery that relieves hip joint pain and improves its functions and is widely performed in the elderly population. New analgesic methods need to be developed to protect these patients from the pain and side effects of opioids used for treatment. Many scales are available to indicate postoperative patient recovery. One of these is the quality of recovery-15 (QoR-15) recovery test, which was first applied by Stark et al. in 2013. We think that an ESPB applied from the sacral region will spread to the lumbar region by diffusion, affect the lumbar plexus, and provide complete analgesia in the ventral and dorsal regions of the hip by affecting the sacral plexus in the sacral region. The investigator's primary aim in this study is to evaluate the effect of sacral erector spinae plane block (S-ESPB) on the quality of recovery and healing after TKA through the QoR-15 score and to evaluate its effect on postoperative pain.

Description:

Total hip arthroplasty (THA) is a surgery that relieves hip joint pain and improves its functions and is widely performed in the elderly population. New analgesic methods need to be developed to protect these patients from the pain and side effects of opioids used for treatment. Many scales are available to indicate postoperative patient recovery. One of these is the quality of recovery-15 (QoR-15) recovery test, which was first applied by Stark et al. in 2013. The investigators think that an ESPB applied from the sacral region will spread to the lumbar region by diffusion, affect the lumbar plexus, and provide complete analgesia in the ventral and dorsal regions of the hip by affecting the sacral plexus in the sacral region. The investigator's primary aim in this study is to evaluate the effect of sacral erector spinae plane block (S-ESPB) on the quality of recovery and healing after TKA, through the QoR-15 score, and to evaluate its effect on postoperative pain.

Anesthesia Technique and Analgesia Protocol a standard to measure postoperative pain severity after THA, and intravenous injection is used as a standard in patients with no contraindications within the scope of the multimodal analgesia protocol. paracetamol 1 gr. 3x1 + Dexketoprofen 50 mg 2x1 and when NRS is 3 and above, 1mg/kg tramadol is administered as a rescue analgesic. In addition, ESPB is applied to patients as a part of multimodal analgesia after THA surgery, unless there are contraindications in the hospitals where the study will be conducted. And 4 mg IV is routinely administered to patients with postoperative nausea and vomiting. Ondansetron is administered . All patients will receive routine monitoring and routine anesthesia management. 20 gauge to patients Intravenous ( IV ) cannulation is provided and 15ml/kg/ h Isotonic fluid will be started. The spinal anesthesia will be applied to the patients by administering 3cc of 0.5% bupivacaine through the L3-L4 or L4-L5 intervertebral space. Patients will then be released to the surgical team for THA surgery. After the surgical procedure is completed, patients will be transferred to the postanesthetic care unit (PACU) for observation. S-ESPB will be applied to patients in Group S

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who will undergo unilateral THA

• Spinal anesthesia

• 18-80-year-old patients

• Patients with ASA I-IV

• Patients who will stay in the hospital for at least 24 hours

Exclusion Criteria:

• Patients who do not want to give consent

• Patients under 18 years of age and over 80 years of age

• Patients for whom regional anesthesia is contraindicated

• Patients with confusion

• Patients with ASA V and above

• Patients with abnormal bleeding profile

• Patients using anticoagulants

• Patients with infection in the area to be treated

• Emergency cases

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• sacral erectör spinae plane group
sacral erectör spinae plane will be applied to patients in Group S

Locations

Country	Name	City	State
Turkey	Konya City Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery-15T	The primary evaluation criteria will be the recording of QoR -15 scores, which indicate the quality of recovery of patients before and at 24 hours after surgery .	One day