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NCT Number: NCT07819682

Dexamethasone and Duration of Spinal Anesthesia

This study will evaluate whether intravenous dexamethasone affects the duration of spinal anesthesia in patients undergoing lower abdominal surgery.

Eligible adult patients classified as ASA I or II will undergo routine preoperative assessment by an anesthetist. Before surgery, patients will receive either intravenous dexamethasone (8 mg diluted in 100 mL normal saline) or 100 mL normal saline alone. The medication will be administered through a peripheral intravenous cannula.

Spinal anesthesia will then be performed using a standard technique. A 25-gauge spinal needle will be used to administer 12-15 mg of 0.75% hyperbaric bupivacaine into the lower lumbar region while the patient is in the sitting position. After confirming the flow of cerebrospinal fluid, the patient will be positioned for surgery.

The level and effectiveness of anesthesia will be assessed using standard sensory and motor assessments. Surgery will begin after an adequate level of numbness and motor block has been achieved. The recovery of sensory and motor function will subsequently be assessed at regular 15-minute intervals by an anesthesia team member who was not involved in administering the spinal anesthesia, to minimize assessment bias.

The main outcome will be the time required for the sensory block to regress from its initial level to the lower thoracic region (T10-T12). Additional outcomes will include the total duration of sensory and motor block and postoperative pain, assessed using a visual pain scale four hours after surgery.

Patient information such as age, sex, diagnosis, type of surgery, duration of sensory and motor block, and postoperative pain score will be recorded and analyzed to determine whether intravenous dexamethasone prolongs the duration of spinal anesthesia.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Holy Family Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location status: Recruiting

Location contact

Jawad Zaheer, MBBS, FCPS

CONTACT

[email protected]

+92 333 5428866

About this study

This study will evaluate the effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in patients undergoing lower abdominal surgery.

Eligible patients will be adults classified as American Society of Anesthesiologists (ASA) physical status I or II and meeting the predefined inclusion and exclusion criteria. All patients will undergo a preoperative assessment by a consultant anesthetist and will be deemed fit for anesthesia and surgery before enrollment.

After establishment of standard monitoring in the operating theatre, an 18-gauge peripheral intravenous cannula will be secured. Patients will receive either 8 mg of dexamethasone diluted in 100 mL of normal saline or 100 mL of normal saline alone, according to the study protocol. The administration will be performed in a manner intended to maintain blinding of the personnel responsible for subsequent assessment of block regression.

Following the intravenous intervention, spinal anesthesia will be performed using a 25-gauge spinal needle with the patient in the sitting position. A dose of 12-15 mg of 0.75% hyperbaric bupivacaine will be administered intrathecally at the L3-L4 or L4-L5 intervertebral space. Correct intrathecal placement will be confirmed by free flow of cerebrospinal fluid through the spinal needle. The patient will subsequently be positioned supine.

The sensory block will be assessed by testing the response to pinprick at the relevant dermatomes, while the degree of motor blockade will be assessed using the Modified Bromage Scale. Surgery will commence after an adequate sensory block extending to the T4 dermatome and a Modified Bromage score of 1 have been achieved.

Following establishment of spinal anesthesia, serial assessments of sensory and motor blockade will be performed at 15-minute intervals by a member of the anesthesia team who was not involved in administration of the spinal anesthetic, in order to minimize assessment bias. Sensory block regression will be assessed sequentially at the dermatomes from T4 toward the lower thoracic levels. The primary outcome will be the duration from establishment of the sensory block until regression to the T10-T12 dermatome level.

Following surgery, patients will be transferred to the Post-Anesthesia Care Unit (PACU), where continued assessment of the sensory and motor blockade will be performed. The total duration of sensory blockade and motor blockade will be recorded. Postoperative pain intensity will be assessed using the Visual Analogue Scale (VAS) at 4 hours after surgery.

The study will collect demographic and clinical variables, including age, sex, primary diagnosis, and type of surgical procedure. Quantitative outcome measures will include the time required for sensory block regression to the T10-T12 level, total duration of sensory blockade, total duration of motor blockade, and postoperative pain intensity at 4 hours. These outcomes will be compared to determine whether intravenous dexamethasone prolongs the duration of hyperbaric bupivacaine spinal anesthesia and influences postoperative analgesic outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing lower abdominal surgeries and orthopaedic surgeries including pelvic and lower extremity surgeries
  • Patients classified as American Society of Anesthesiologists (ASA) physical status I or II

Exclusion criteria

  • Patients with a history of spinal surgery, spinal instrumentation, or previous failed spinal anaesthesia
  • Patients with pre-existing neurological disorders, peripheral neuropathy, or sensory/motor deficits
  • Patients with known hypersensitivity or allergy to local anaesthetic agents or dexamethasone
  • Patients with congenital spinal deformities or acquired spinal conditions such as advanced spondylosis or kyphoscoliosis that may interfere with neuraxial block
  • Patients with contraindications to spinal anaesthesia, including coagulopathy, local infection at the injection site, or raised intracranial pressure
  • Patients with diabetes mellitus, chronic steroid therapy, immunosuppression, or systemic infection (due to steroid use)
  • Pregnant patients or those undergoing emergency surgeries

Treatment and study plan

Dexamethasone

Drug

Will receive 8mg of Dexamethasone in 100ml of Normal saline 10 minutes prior to induction of Anesthesia

Placebo

Drug

Will receive 100ml Normal saline 10 minutes prior to induction of spinal anesthesia

Primary outcomes

  1. Time to Spinal Anesthesia regression

    Time frame: From administration of spinal anesthesia until sensory block regresses by two dermatomes, assessed for up to 6 hours after spinal anesthesia

    Time in minutes from administration of spinal anesthesia until sensory block regresses by two dermatomes from the maximum sensory block level.

  2. Time in minutes from administration of spinal anesthesia until the patient first requests rescue analgesia.

    Time frame: From administration of spinal anesthesia until the patient's first request for rescue analgesia, assessed for up to 6 hours after spinal anesthesia.

Study contacts

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

Tayyab Principal Investigator, MBBS

CONTACT

[email protected]

+92 308 5220273

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Pakistan

Other

Registry information

Official study title

Effect of Intravenous Dexamethasone on The Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery-Quasi Experimental Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 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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