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

Effect of Spinal Anesthesia With Bupivacaine Versus Prilocaine on Postoperative Shivering After Inguinal Hernia Repair : a Prospective Randomized Double Blind Study

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07564180
Enrollment
80
Registered
2026-05-04
Start date
2026-05-01
Completion date
2027-08-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Shivering

Keywords

Spinal, Prilocaine, Bupivacaine, Shivering, Hernia.

Brief summary

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

Detailed description

Inguinal hernia is the most common type of abdominal hernia, more common in men than women. Inguinal hernia repair is performed under general, spinal anesthesia or local anesthesia. Core body temperature is normally tightly regulated to within a few tenths of a degree. The major thermoregulatory defenses in humans are sweating, arteriovenous shunt vasoconstriction, and shivering. Spinal anesthesia is considered a safe anesthetic technique for the surgery, however 40 to 60 percent of patients' experience shivering due to vasodilatation, which facilitates rapid heat loss and causes a redistribution of body heat from the core to peripheral tissue. However, perioperative heat loss due to exposure of skin, evaporation from exposed sites, cold intravenous fluids, contribute to factors that predispose shivering. Postoperative shivering can be either thermos-genic with hypothermia or nonthermogenic associated with pain modulation and surgical stress. Shivering is considered undesirable, as these random spontaneous, asynchronous skeletal muscle contractions increases the basal metabolism with increase in oxygen consumption up to be 600% hypoxemia, metabolic acidosis, triggering myocardial ischemia, increased wound pain, delayed wound healing, as well as increase in blood pressure, intraocular and intracranial pressure. Bupivacaine is a long acting local anesthetic belonging to the amide group it is more stable and less likely to cause allergic reactions among other local anesthetics however; it delays hospital discharge in ambulatory surgery. Prilocaine is a local anesthetic belonging to the amide group with rapid onset, intermediate potency, and action. The old local anesthetics prilocaine was reintroduced in the market as hyperbaric prilocaine 2% which provides anesthesia for 75-90 minutes after spinal administration, thus increasingly used in the ambulatory setting. Since bupivacaine 0.5% has significantly prolonged postoperative analgesic duration versus prilocaine 2%, thus We hypothesis that bupivacaine may have a superior effect on minimizing postoperative shivering through providing better analgesia. The main aim of this study is to compare spinal anesthesia with prilocaine 2%, versus bupivacaine 0.5% on postoperative shivering during repair of inguinal hernia.

Interventions

DRUGBupivacaine Spinal Anesthesia

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

DRUGPrilocaine spinal anesthesia

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

DRUGSpinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine)

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.

Sponsors

Amr mohamed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Masking description

The patient and the observers collecting data will be blinded to the patient's study group allocation.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
shivering using bedside shivering assesement score ( BSAS)one year

Contacts

CONTACTamr mohamed, doctorate degree
amr.mohamed.a1@gmail.com020 1140202083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026