A randomized prospective comparative study of incidence of post dural pucture backache(PDPB) following median and paramedian approach for administration of subarachnoid block in patients undergoing cesarian section

Background of study :

Single injection ol of subarachnoid block with local anaesthetic is the most common method for administration of Anaesthesia in patient posted for cesarean section, there are two common approaches to reach subarachnoid space

i, e midline and paramedian

Post-dural puncture backache (PDPB), which is characterized by continuous pain around the site of spinal puncture without any radicular pain, is one of the complications after spinal anesthesia3

Excessive stretching of spinal ligaments by paraspinal muscular relaxation and/or localized tissue trauma are proposed as pathophysiological factors for PDPB3

This pain can be of short duration lasting for 72 h to 1 week or can be persistent lasting beyond 3 months4

Research Question :

Is there any difference in the incidence of post-dural puncture backache (PDPB) after administration of subarachnoid block by either median or paramedian approach in cases of cesarean section?

Objective :

Primary Objective:

To determine the incidence of post-dural puncture backache (PDPB) in both groups in the first 3 months postoperatively

Secondary Objectives:

Backache on Numerical Rating Scale (NRS) in both groups after 24 hours,1 week, 1 month, 2 months and 3 months postoperatively

The number of attempts required at subarachnoid block by either approach

Total requirement of additional analgesics for low backache in first 24 and 48 hours postoperatively (Morphine equivalents)

Compare the incidence of PDPH in the two groups in first 72 hours

Methodology:

210 patients undergoing elective or emergency cesarean section shall be randomly divided to receive subarachnoid block by either median (Group M, n=105) or paramedian (Group P, n=105) approach.

Subarachnoid block shall be administered with 2.6 ml of 0.5% heavy Bupivacaine at L3-L4 interspace by a 27G Quincke needle in the sitting position in both groups for anesthesia.

Postoperatively, the patient shall be administered analgesics in the form of Inj. Paracetamol 1 gm IV 8 hourly and Inj. Diclofenac 75 mg IM 12 hourly for next 48 hours

Rescue analgesia shall be administered in the form of Inj. Tramadol 1mg/Kg intravenously

Twenty-four hours after operation, the patient shall be interviewed for low back pain

If patients had back pain, she shall be enquired about the level of low back pain, characteristics, aggravating factors, and degree of pain using a numeric rating scale (NRS).

We shall specifically evaluate back pain and not transient neurological symptoms (e.g. unilateral or bilateral pain or dysaesthesia with radiation into buttocks, thighs, calves or legs)

Severity of PDPB shall be categorized as either no backache (NRS 0), mild (NRS 1-3), moderate (NRS 4-7) or severe (NRS >7)

Patients shall be asked the same questions over the telephone after 7 days, 1 month, 2 months, and 3 months