Study on the occurrence of head ache after spinal anaesthesia in pregnant women

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2022/02/040343
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary

After obtaining approval from Department research monitoring committee, Institute ethics committee and completing CTRI registration, patients will be recruited. Written informed consent explaining about the procedure, risks and any adverse events will be obtained from the patients before being enrolled into the study during pre-anesthetic checkup. All patients are expected to have adequate nil per oral before the surgery. Routine monitors (consisting of a pulse oximeter, ECG and a non-invasive blood pressure cuff) are applied. Baseline measurements are obtained while patients are at supine position. Following co-loading with Ringer’s lactate solution 500 mL, depending upon the patient’s allocation, patients will begiven 0.5% hyperbaric bupivacaine 1.8ml or with 1.3ml of 0.5% hyperbaric Bupivacaine + 0.5 ml fentanyl (according to the anesthetist’s preferences) via a 25 G Quincke-tip spinal needle in the left lateral position at the L3–4 or L4-5 vertebral level using median (GROUP M ) (n= 120) or paramedian approaches (GROUP PM) (n=120). Time of administering the block will be noted. Hemodynamic parameters will be monitored. Then, patients will be kept supine with wedge immediately after the subarachnoid block. Surgery is initiated when the sensory block level reaches the adequate levels. Patient’s demographic data (age, weight, height, BMI), duration of surgery (defined as time taken from completion of the subarachnoid block to the skin closure), number of hypotensive episodes (defined as the mean arterial pressure (MAP) decreases by 20% of baseline or systolic blood pressure goes <90 mm Hg), total amount of fluids (crystalloids and colloids) and blood ( and /or blood products) infused during surgery, total vasopressor requirements and intraoperative nausea and vomiting are noted. Post operatively all the patients are given intravenous fluids at rate of 4ml/kg/hr for first 10 kilograms of body weight, 2ml/kg /hr for next 10 kilograms of body weight and 1 ml/kg/hr for remaining kilograms of body weight . Postoperatively all the patients are given injection Paracetamol 1 gram intravenously once in 8 hours. The patients are questioned for the possible occurrence of PDPH on the first, third, fifth and seventh postoperative days evaluated over clinical assessments and/or telephonic conversations. (PDPH is defined according to the International Classification of Headache Disorders (ICHD-3) -7.2.1 which defines PDPH as headache occurring within 5 days of a lumbar puncture, caused by cerebrospinal fluid (CSF) leakage through the dural puncture. It is usually accompanied by neck stiffness and/or subjective symptoms. It remits spontaneously within 2 weeks, or after sealing of the leak with autologous epidural lumbar patch.) The severity of PDPH is evaluated and classified as follows: Mild PDPH : - Slight restriction of daily activities

-Patient not bed ridden

-No associated symptoms

-Responds well to non-opiate analgesics.

 Moderate PDPH: - Significant restriction of daily activities

-Patient is bed ridden most of the day

-associated symptoms may or may not be present

-requires the addition of opiates.

 Severe PDPH:

-Complete restriction of daily activities

- Patient is bed ridden all the day

- associated symptoms are present

-not responsive to conservative management.

 â— The conservative management of PDPH includes :

1) Adequate Bed Rest for 24-48 hours.

2) Adequate hydration

3) Analgesia

4) Caffeine

 The occurrence of neck stiffness, photophobia, nausea/vomiting and blurring of vision are recorded on day 1 of post operative period.

• Neck Stiffness is clinically assessed by Chin tuck test and rotation test. 1) Chin Tuck test is done by asking the patient to stand on feet with back and head against the wall and asked to keep the chin tucked and bring the head as forward as possible. Increased pain indicates positive test.

• 2) Rotation test is done by asking the patient to stand on feet with back and head against the wall and asked to rotate to one side as possible as they can. Increased pain indicates positive test.

 

• Photophobia is assessed clinically by PEN LIGHT TEST -A pocket flashlight (penlight) powered by two 1.5 V batteries will be shown directly into one of the eyes from a distance of 15 cm for 2 seconds. The presence of discomfort will be recorded as a positive test. The test is then repeated for the other eye.

 

• Nausea is clinically assessed by 12, Grade 0 - no nausea

Grade 1 – Loss of appetite without alteration in

eating habits

Grade 2 – Oral intake decreased without significant

weight loss, dehydration, or malnutrition

Grade 3 – Inadequate oral fluid or caloric intake ;

tube feeding ,TPN or hospitalization

Indicated.

• Vomiting is clinically assessed by12,

Grade 0 : no vomiting

Grade 1 :  1-2 episodes in 24 hours

Grade 2 :  3-5 episodes in 24 hours; IV fluids

indicated

Grade 3 :  >/= 6 episodes in 24 hours ; IV fluids

indicated; tube feeding or TPN or

hospitalization indicated

Grade 4: Life threatening consequences ; Urgent

Intervention needed.

Grade 5: Death.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-16
• Study Start: 2022-02-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

240 pregnant women between the ages of 18-45 years, ASA physical status II and III , scheduled to undergo emergency cesarean section under Subarachnoid block (spinal anesthesia).

Exclusion Criteria

• 1. contraindication to neuraxial anesthesia.
• 2. Known allergy to bupivacaine.
• 3. Previous H/O spinal puncture failure.
• 4. Preoperative presence of any other abdominal mass or ascites.
• 5. Patients with H/O previous PDPH or chronic headache (migraine).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of Post dural punctural headache in median and paramedian approach of	Incidence of headache occurring within 5 days of a lumbar puncture
Subarachnoid block in lower segment cesarean section.	Incidence of headache occurring within 5 days of a lumbar puncture

Secondary Outcome Measures

Name	Time	Method
To compare the incidence of neck stiffness, nausea & vomiting, photophobia and blurring of vision in median and paramedian approach of subarachnoid block in lower segment cesarean section.	Incidence of neck stiffness, nausea & vomiting, photophobia and blurring of vision occurring within 5 days of a lumbar puncture

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education and Research; 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal Institute of Postgraduate Medical Education and Research

🇮🇳Pondicherry, PONDICHERRY, India

Dr Hari Haran R

Principal investigator

9677729550

hariharan134645@gmail.com