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NCT Number: NCT07564180

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine Spinal Anesthesia

Drug

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

Other names: Marcaine

Prilocaine spinal anesthesia

Drug

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

Other names: Takipril

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.

Other names: intrathecal

Primary outcomes

  1. shivering using bedside shivering assesement score ( BSAS)

    Time frame: one year

  2. shivering using bedside shivering assesement score ( BSAS)

    Time frame: 1 year

    shivering using bedside shivering assesement score ( BSAS)

Study contacts

Contact information is provided by the study sponsor or research team.

amr mohamed, doctorate degree

CONTACT

[email protected]

020 1140202083

Sponsors and collaborators

Lead sponsor

Amr mohamed

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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