Trial Outcomes & Findings for Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery (NCT NCT03792191)

Results Overview

Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

280 participants

Primary outcome timeframe

Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Results posted on

2021-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasonography Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Sliding the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Overall Study STARTED	140	140
Overall Study COMPLETED	140	140
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Sliding the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Total n=280 Participants Total of all reporting groups
Age, Continuous	30.2 years STANDARD_DEVIATION 5.9 • n=140 Participants	30.3 years STANDARD_DEVIATION 5.5 • n=140 Participants	30.3 years STANDARD_DEVIATION 5.7 • n=280 Participants
Sex: Female, Male Female	140 Participants n=140 Participants	140 Participants n=140 Participants	280 Participants n=280 Participants
Sex: Female, Male Male	0 Participants n=140 Participants	0 Participants n=140 Participants	0 Participants n=280 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	140 participants n=140 Participants	140 participants n=140 Participants	280 participants n=280 Participants
Height	159.5 cm STANDARD_DEVIATION 6.1 • n=140 Participants	160 cm STANDARD_DEVIATION 6.1 • n=140 Participants	159.7 cm STANDARD_DEVIATION 6.1 • n=280 Participants
Weight	102 kg n=140 Participants	103 kg n=140 Participants	102 kg n=280 Participants
Body mass index	40.2 kg/m^2 n=140 Participants	39.2 kg/m^2 n=140 Participants	39.8 kg/m^2 n=280 Participants
Gestational age (weeks)	38 weeks n=140 Participants	38 weeks n=140 Participants	38 weeks n=280 Participants
Nulliparous	21 Participants n=140 Participants	19 Participants n=140 Participants	40 Participants n=280 Participants
Ease of landmark palpation 1	11 Participants n=140 Participants	17 Participants n=140 Participants	28 Participants n=280 Participants
Ease of landmark palpation 2	57 Participants n=140 Participants	62 Participants n=140 Participants	119 Participants n=280 Participants
Ease of landmark palpation 3	63 Participants n=140 Participants	54 Participants n=140 Participants	117 Participants n=280 Participants
Ease of landmark palpation 4	9 Participants n=140 Participants	7 Participants n=140 Participants	16 Participants n=280 Participants

PRIMARY outcome

Timeframe: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow	3 needle passes Interval 1.0 to 34.0	3 needle passes Interval 1.0 to 23.0

SECONDARY outcome

Timeframe: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow	1 skin punctures Interval 1.0 to 6.0	1 skin punctures Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass	40 Participants	45 Participants

SECONDARY outcome

Timeframe: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture	108 Participants	111 Participants

SECONDARY outcome

Timeframe: Assessed from enrollment in the study until completion of cesarean delivery

The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Duration of the Spinal Procedure	76 seconds Interval 26.0 to 734.0	59 seconds Interval 19.0 to 700.0

SECONDARY outcome

Timeframe: Assessed at 1 minute after intrathecal injection

Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Patient Satisfaction	5 units on a scale Interval 1.0 to 5.0	4 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Number of Participants With Vascular Puncture	9 Participants	9 Participants

SECONDARY outcome

Timeframe: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Number of participants with paresthesia reported by the subjects during performing the spinal procedure

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Number of Participants With Paresthesia	16 Participants	17 Participants

SECONDARY outcome

Timeframe: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed up to 20 minutes after intrathecal injection

Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.

Outcome measures

Outcome measures
Measure	Ultrasonography n=140 Participants Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space	Palpation n=140 Participants Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Sham Ultrasound Procedure: Moving the ultrasound probe on the patient's back with the machine in the freeze position. Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces. Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space
Number of Participants With Failed Spinal Block	3 Participants	4 Participants

Adverse Events

Ultrasonography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Palpation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohamed Mohamed Tawfik

Mansoura University

Phone: 1001183400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place