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Effect of spinal anesthesia with bupivacaine versus prilocaine on postoperative shivering after inguinal hernia repair : a prospective randomized double blind 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prilocaine group | Active Comparator | Prilocaine intrathecal injection ( spinal anesthesia ) |
|
| Buivacaine group | Active Comparator | Bupivacaine intrathecal injection ( spinal anesthesia ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Spinal Anesthesia | Drug | Group B: (n=40) patients receiving hyperbaric bupivacaine 0.5% (Marcaine, Sunny Medical, Egypt). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| amr mohamed, doctorate degree | Contact | 020 1140202083 | amr.mohamed.a1@gmail.com |
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Reeham. S. Ebied, Hanan. F. Khafagy, Mohamed. Z. Ali, Yasser M Samhan.
Feb 2026- Feb 2027
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2026 |
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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.
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The patient and the observers collecting data will be blinded to the patient's study group allocation.
| Prilocaine spinal anesthesia | Drug | Group P; (n=40) will receive prilocaine2% (Takipril, Sunny Medical, Egypt). |
|
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| 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. |
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| Apr 26, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000775 | Anesthesia, Spinal |
| D011318 | Prilocaine |
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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