A Phase 4 interventional study of Bupivacaine Spinal Anesthesia and Prilocaine spinal anesthesia in Postoperative Shivering, sponsored by Amr mohamed. Not yet recruiting. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Amr mohamed · Phase 4, Interventional, and Supportive care
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.
257 studies on the registry are indexed under Hernia; 37 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 167 interventional studies indexed under Hernia.
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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, to amide local anesthetics, mental disturbance, congenital or acquired methemoglobinemia, coagulation disorders will also be excluded from the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prilocaine intrathecal injection ( spinal anesthesia )
Drug: Prilocaine spinal anesthesia · Drug: Spinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine)
Bupivacaine intrathecal injection ( spinal anesthesia )
Drug: Bupivacaine Spinal Anesthesia · Drug: Spinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine)
Group B: (n=40) patients receiving hyperbaric bupivacaine 0.5% (Marcaine, Sunny Medical, Egypt).
Also known as: Marcaine
Group P; (n=40) will receive prilocaine2% (Takipril, Sunny Medical, Egypt).
Also known as: Takipril
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
shivering using bedside shivering assesement score ( BSAS)
Time frame: one year
shivering using bedside shivering assesement score ( BSAS)
shivering using bedside shivering assesement score ( BSAS)
Time frame: 1 year
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Reeham. S. Ebied, Hanan. F. Khafagy, Mohamed. Z. Ali, Yasser M Samhan.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Feb 2026- Feb 2027
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bupivacaine · Prilocaine