Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries.

NCT03422354 | Completed DMC

• 1 other identifier: N -73/2017
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The paravertebral block (PVB) is a block of the mixed nerve soon after it exits the intervertebral foramen.(2) It provides intense unilateral analgesia of long duration and has become the primary anesthetic for many applications.(3) Paravertebral Block (PVB) involves injection of local anaesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anaesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.(4) The increasing demand for hip arthroplasties over the last decades has sparked the creation of new and innovative anesthetic techniques and analgesic pathways with the goal to support best possible outcomes among this frequently elderly patient population. As a result, today different perioperative treatment pathways are available to physicians and their patients. In this context, the focus has shifted to techniques based on regional anesthetic and analgesic techniques. This trajectory has been fueled by a number of advantages including effective, long-lasting and focused pain control, decreased need for systemic analgesics and earlier mobilization.

Conditions

Ultrasound Guided L1,L2 Paravertebral Block

Outcome Measures

Primary Outcomes (1)

• Dose of hypotensive drugs

  Required dose of hypotensive drugs in both groups

  One day postoperatively

Secondary Outcomes (2)

• Pain assessment

  One day postoperatively

• Total dose of opioids

  One day postoperatively

Other Outcomes (1)

• Blood transfusion recorded

  One day postoperatively

Study Arms (2)

Paravertebral block Group

ACTIVE COMPARATOR

Patients will receive single shot L1-L2 PVB before undergoing GA Full monitoring with ECG , NIBP , puls oximetry will be applied. The level between L1 and L2 will be identified using U/S as well as transverse processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A 22-gauge Tuohy needle will be advanced until it made contact with the transverse process. The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25% will be injected slowly To control intraoperative blood pressure, fentanyl will be used as well as hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.

Procedure: Ultrasound guided PVB with General Aneasthesia; Device: Ultrasound; Drug: Paravertebral block; Drug: General Aneasthesia

General anesthesia Group

ACTIVE COMPARATOR

Patients will receive only GA All patients in the study will receive GA in the form of propofol 2mg/kg , atracurium 0.5ml/kg ,fentanyl 100 microgram in induction with ETT and mechanical ventilation , full monitoring with ECG , NIBP and puls oximetry will be applied. To control intraoperative BP,fentanyl will be used as well as,hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded. To achieve post operative analgesia, intravenous paracetamol( 1gram ) and pethidine IV (50 mg ) will be added when needed

Device: Ultrasound; Drug: General Aneasthesia

Interventions

Ultrasound guided PVB with General Aneasthesia PROCEDURE

An 18G Tuohy needle was inserted perpendicularly at L1,2 to hit the transverse process via an out-of-plane approach. This then directed over the top of the bony structure. The deviation of the needle was kept at 15°. The space was identified using loss of resistance without U/S After negative aspiration, Transverse process visualisation was possible. Distances measured using U/S correlated well with needle depth. Injection of local anaesthetic was visualised as turbulence at L1,2 in all patients. The onset time for this block is 15-25 min

Paravertebral block Group

Ultrasound DEVICE

Ultrasound

General anesthesia Group; Paravertebral block Group

Paravertebral block DRUG

Patients will receive single shot L1-L2 PVB before undergoing GA

Paravertebral block Group

General Aneasthesia DRUG

General Aneasthesia

General anesthesia Group; Paravertebral block Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients from 20 to 60 years.
• Genders eligible for study: both.
• ASA I-II.
• No contraindications for application of regional anesthesia as Patient refusal, local anesthetic, allergy, local sepsis or infection at puncture site, INR \> 1.5 or \< 12 hours post LMWH.

You may not qualify if:

• Extremes of age.
• ASA III-IV.
• Hypovolemia.
• Increased intracranial pressure.
• Coagulopathy or thrombocytopenia less than 100000/ml.
• Sepsis (increased risk of meningitis).
• Infection at the puncture site.
• Pre-existing neurologic disease.
• Patient refusal.
• History of allergy to local anesthetic.

Sponsors & Collaborators

• Cairo University: lead
• Mohamed, Ahmed A., M.D.: collaborator
• Hala Mostafa Gomaa: collaborator
• Abdelhamid, Bassant Mohamed, M.D.: collaborator
• Mohamed saeid Ali: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The patients were randomized to two groups using a computer-generated list and kept in a sealed envelope into two groups:
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia&I.C.U and Pain Clinic

Model Details: after approval of the ethical committee (N-73-2017)Which approval date was 12/2/2018 74 patients scheduled for elective hip surgery were included in the study after detailed description and signing a detailed informative consent (figure1). The patients were randomized to two groups using a computer-generated list and kept in a sealed envelope into two groups: * Group P: 37 patients were received single shot L1-L2 paravertebral block before undergoing general anesthesia (GA). * Group G: 37 patients were received GA. The target of the mean blood pressure was to be more than 50mm Hg while the systolic pressure to be between 80 and 100 mm Hg and the diastolic blood pressure targeted to be 50 to 70 mmHg.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: February 5, 2018
• Study Start: February 12, 2018
• Primary Completion: May 10, 2018
• Study Completion: May 15, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)