Transversus Abdominis Plane Block Versus Paravertebral Block for Post Operative Pain Relief in Open Renal Surgeries

• ClinicalTrials.gov Identifier: NCT04697420
• Recruitment Status: Completed
• First Posted: January 6, 2021
• Last Update Posted: August 16, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Abdelrahman Hussein Ali, Assiut University

Study Description

Brief Summary:

Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of many post operative complications .

There are a lot of regional anesthetic techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block.

TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries.It is safer technique than PVB, but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Procedure: Thoracic paravertebral block; Procedure: Transversus abdominis plane block	Not Applicable

Detailed Description:

Pain relief after renal surgeries is essential as it may lead to reduction in the incidence of post operative respiratory complications . A lot of patients presented to these operations may have comorbidities as impaired renal function and respiratory problems , conditions like these may contraindicate aministration of systemic analgesia as opioids .

There are a lot of techniques to provide analgesia postoperatively as paravertebral block (PVB) and transversus abdominis plane (TAP) block .

Paravertebral block is effective technique for post operative analgesia for upper abdominal surgeries , but it may be associated with some complications as : pneumothorax , spread of local anesthetic to the epidural space and paravertebral blood vessels , and this may lead to systemic toxicity of local anesthetic .

TAP block has been used to provide postoperative analgesia in a lot of abdominal surgeries including upper abdominal surgeries , but it is safer technique than PVB , but the effectiveness of TAP block is unknown in comparison with PVB in post operative analgesia after renal surgeries .

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Transversus Abdominis Plane Block Versus Paravertebral Block for Post Operative Pain Relief in Open Renal Surgeries: a Randomized Controlled Trial
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: October 24, 2018
• Actual Study Completion Date: January 23, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group (P); the patients were received paravertebral block to control pain postoperatively.	Procedure: Thoracic paravertebral block; Thoracic paravertebral block is a technique in which , the local anesthetic agent is injected in the paravertebral space to anesthetise the spinal nerves after emerging from the vertebral canal in order to provide analgesia in the thoracic and upper abdominal area .
Experimental: Group (T); the patients were received transversus abdomins plane (TAP) block to control pain postoperatively.	Procedure: Transversus abdominis plane block; Transversus abdominis plane block is a technique is mostly done under ultrasound guidance to identify the transversus plane between the internal oblique muscle and the transverses abdominis muscle , the space in which the neurovascular supply of the anterior abdominal wall is present , and hence the injection of local anesthetic agent in this space results in anesthesia of the anterolateral aspect of the abdominal wall.

Outcome Measures

Primary Outcome Measures :

1. comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block [ Time Frame: 24 hours ]
   comparison between the post operative analgesic effect of transversus abdominis plane block and paravertebral block by the following assessment methods: Visual Analogue Scale score (VAS) immediately postoperative and through the first 24 hours postoperativly, total analgesic consumption through the first 24 hours postoperatively, and time of first analgesic request in the postoperative period

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Aged 18 - 60 years
• ASA I-II class

Exclusion Criteria:

• Patient refusal
• Any contraindication of regional anesthesia block (Coagulopathy,infection at the needle insertion site)
• Patients with allergy to amide local anesthetics or medication included in the study.

Contacts and Locations

Locations

Egypt

Assiut University

Assiut, Egypt, 71515

Sponsors and Collaborators

Assiut University

Investigators

• Study Director: Essam Ezzat, Professor; Professor of anesthesia, intensive care and pain management , formerly head of the department

More Information

• Responsible Party: Abdelrahman Hussein Ali, Resident doctor, Assiut University
• ClinicalTrials.gov Identifier: NCT04697420
• Other Study ID Numbers: AHAAssiut
• First Posted: January 6, 2021
• Last Update Posted: August 16, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations