Spinal Anesthesia With Bupivacaine Versus Prilocaine on Postoperative Shivering After Inguinal Hernia Repair

NCT07564180 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Theodore Bilharz
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effect of spinal anesthesia with bupivacaine versus prilocaine on postoperative shivering after inguinal hernia repair : a prospective randomized double blind study

Conditions

Postoperative Shivering

Keywords

Spinal, Prilocaine, Bupivacaine, Shivering, Hernia.

Outcome Measures

Primary Outcomes (2)

• shivering using bedside shivering assesement score ( BSAS)

  one year

• shivering using bedside shivering assesement score ( BSAS)

  shivering using bedside shivering assesement score ( BSAS)

  1 year

Study Arms (2)

Prilocaine group

ACTIVE COMPARATOR

Prilocaine intrathecal injection ( spinal anesthesia )

Drug: Prilocaine spinal anesthesia; Drug: Spinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine)

Buivacaine group

ACTIVE COMPARATOR

Bupivacaine intrathecal injection ( spinal anesthesia )

Drug: Bupivacaine Spinal Anesthesia; Drug: Spinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine)

Interventions

Bupivacaine Spinal Anesthesia DRUG

Group B: (n=40) patients receiving hyperbaric bupivacaine 0.5% (Marcaine, Sunny Medical, Egypt).

Also known as: Marcaine

Buivacaine group

Prilocaine spinal anesthesia DRUG

Group P; (n=40) will receive prilocaine2% (Takipril, Sunny Medical, Egypt).

Also known as: Takipril

Prilocaine group

Spinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine) DRUG

In both groups the patients will be in the sitting position after preparation and draping of the patient's back. A skin wheal will be made by 1 ml of lidocaine HCl 2% at L3-4 interspace using a 25-gauge needle. Hyperbaric bupivacaine 0.5% will be given in dose (15mg) in group B and hyperbaric prilocaine2% in dose (60mg) in Group P. Anesthesia will be prepared by personnel not involved in this study. Patients will be supplemented with oxygen 5.0 l/minute by face mask. Time to achieve T10 dermatome will be recorded also motor level by modified Bromage motor blockade score; 4=no motor block, 3=can flex leg at knee, 2=can flex leg at the ankle and 1= complete motor block. The time needed to reach the maximum block will be recorded. In both groups the hemodynamic parameters will be recorded before block, immediately after block then every 5 min till end of the operation. Need for sedation or analgesia will be recorded.

Also known as: intrathecal

Buivacaine group; Prilocaine group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with inguinal hernia under spinal anesthesia aged from 20 to 60 years

You may not qualify if:

• Patients suffering from neurological diseases, uncompensated cardiac or respiratory problems, active lumber disc herniation, and history of addiction to other substances as well as those under treatment affecting results will be excluded from the study. Also, patients with a history of previous back surgery, infection at the injection site, hypersensitivity to amide local anesthetics, mental disturbance, congenital or acquired methemoglobinemia, coagulation disorders will also be excluded from the study.

Sponsors & Collaborators

• Amr mohamed: lead

MeSH Terms

Conditions

Hernia

Interventions

Bupivacaine; Anesthesia, Spinal; Prilocaine; Injections, Spinal

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

amr mohamed, doctorate degree

CONTACT

020 1140202083; amr.mohamed.a1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patient and the observers collecting data will be blinded to the patient's study group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: After Ethics Committee approval and patients' written informed consent, 40 ASA physical status I-II male patients from 20- 60 years old scheduled for elective inguinal hernia repair under spinal anesthesia will be included in this randomized double-blind comparative study. They will be randomly allocated to one of two groups according to a computer generated list of 80 patients each. Group B: (n=40) patients receiving hyperbaric bupivacaine 0.5% (Marcaine, Sunny Medical, Egypt). Group P; (n=40) will receive prilocaine2% (Takipril, Sunny Medical, Egypt). Patients suffering from neurological diseases, uncompensated cardiac or respiratory problems, active lumber disc herniation, and history of addiction to other substances as well as those under treatment affecting results will be excluded from the study.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Feb 2026- Feb 2027