Evaluation of Effectivity of Erector Spina Plane Block With Different Levels

Gaziosmanpasa Research and Education Hospital

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: control group; Procedure: T9 Level Erector Spinae Plane Block; Procedure: T7 Level Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT04316416

GaziosmanpasaTREH18

Details and patient eligibility

About

In last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. In this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.

Full description

Three groups were planned for this study.Randomization was planned with the closed envelope method. İn the first group, the ESP(erector spinae plane) block procedure will be applied from the T7 level bilaterally and in the second group it will be applied from the T9 level bilaterally. ESP block procedure will not be applied in the third group and this group will be considered as the control group. A comparison of NRS (Numeric Rating Scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.

Enrollment: 103 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA 1-2 Elective cholecystectomy surgery
• 18-65 years old patients

Exclusion criteria

• ASA 3-4 patients
• Patient refusal
• several lung and heart disease
• Contraindications to regional anesthesia
• BMİ > 35 patients
• Known allergy to local anesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Severe kidney or liver disease
• Patient with psychiatric disorders

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 3 patient groups, including a placebo group

T7 Bilateral ESP block

Active Comparator group

Description:

Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging T7 (7th thoracal vertebrae ) transverse process accompanied by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed.

Treatment:

Procedure: T7 Level Erector Spinae Plane Block

T9 bilateral ESP block

Active Comparator group

Description:

Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging transverse process T9 (9th thoracal vertebrae) by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed.

Treatment:

Procedure: T9 Level Erector Spinae Plane Block

Control group

Placebo Comparator group

Description:

Postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard pain follow-up and monitorization will be performed. No block will be performed in this group.

Treatment:

Drug: control group