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Clinical Trials/CTRI/2024/05/067713
CTRI/2024/05/067713
Not yet recruiting
Not Applicable

Effects of Ultrasound guided Pudendal Nerve block on post operative pain and quality of recovery in patients undergoing hemorrhoidectomy under Spinal Anaesthesia :A Randomised Control Study

DR Kamalieshree M1 site in 1 country100 target enrollmentStarted: May 31, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
DR Kamalieshree M
Enrollment
100
Locations
1
Primary Endpoint
To compare the effect of pudendal nerve block with spinal anaesthesia versus only spinal anaesthesia on postoperative pain (VAS score)at 6th hour in patients undergoing haemorrhoidectomy

Overview

Brief Summary

The anesthetic procedure will be standardized. Pre anaesthetic evaluation and

relevant investigations will be advised with standard nil per oral instructions.

In the preoperative area patient will be connected to monitors and baseline

Systolic Blood Pressure (SBP), Diastolic blood pressure (DBP) , Respiratory

rate (RR) ,Heart rate(HR),Oxygen saturation (SPO2) will be monitored and

study drug will be prepared by the nurse not involved in the study.

ï‚· In the pre operative room, intravenous line of 18 G are established. Patient is

started with 500ml of Ringer lactate solution.A brief explanation of the

procedure and the type of anaesthesia to be given is explained to the patient.

ï‚· Once the patient gets shifted inside the OT, all the monitors are

connected.Patient’s basal parameters –Heart rate, saturation, blood pressure

and ECG, will be monitored using pulse-oximetry, non invasive blood pressure

and ECG monitor. Under sterile aseptic precautions parts painted and draped

patient in sitting or lateral position, under local anaesthesia,using midline

approach, Lumbar puncture is done under the L3-L4 intervertebral space using

25G Quinckes spinal needle, once the clear and free flow of CSF is noted

,Inj.Bupivacaine 0.5% (H )of 2ml without additive agents is given,

after the spinal injection patient is repositioned.

Pudendal nerve block was performed after the spinal Anaesthesia, a low-

frequency 2–5-MHz curved array ultrasound Probe allowed the visualization

of important landmarks: the Ischial spine, pudendal artery, sacrospinous

ligament, Sacrotuberous ligament, and pudendal nerve. After sterile skin And

probe preparation within a transparent plastic sheath,Scanning is performed in

transverse planes to visualize the Ischium forming the lateral border of the

sciatic notch. By Moving the ultrasound probe in a cephalad-caudal

direction,The ischium appears as a progressively lengthening Hyperechoic line

that is widest at the ischial spine level. The Ischium is initially seen as a curved

line as it forms the Posterior aspect of the acetabulum. When the probe is at

The ischial spine level, the ischium will appear as a straight Line. At this level,

a color Doppler is used to localize the Internal pudendal artery pulsations in

close proximity to the Ischial spine. The inferior gluteal artery is often seen as

another arterial pulsation lateral to the tip of the ischial spine and is

Accompanied by the sciatic nerve—mistaking this artery for The pudendal

artery could result in sciatic nerve block. The Sacrospinous ligament will

appear as a hyperechoic line in continuity with the ischial spine, with lower

echogenicity than Bone. Similarly, the sacrotuberous ligament is seen as a light

Hyperechoic line deep within the gluteus maximus muscle and appeared

parallel and superior to the sacrospinous ligament. The localization of the

pudendal nerve is targeted in the Plane between these two ligaments. Under

ultrasound guidance, a peripheral nerve–stimulating needle is inserted and

Advanced in line with the ultrasound probe, medial to the Internal pudendal

artery. Once the needle passes through the Sacrotuberous ligament, a “click” is

usually felt and a small Volume (1–2 mL) of local anesthetic is injected. The

solution appeared as a hypoechoic collection, in order to identify The plane

between the sacrotuberous and the sacrospinous ligaments and to accentuate

the pudendal nerve appearance.The needle is inserted medially toward the

pudendal artery, as the pudendal nerve is generally located medial to this

artery. Ten Milliliters of ropivacaine 0.75% was injected within this fascial

plane, after negative aspiration. The procedure was then Repeated identically

on the contralateral side.Thirty minutes later, if the sensation of the skin

around the anus and the contractility of the anus is decreased this indicates that

the pudendal nerve is successfully blocked

. After the completion of the

surgical procedure patient gets shifted into the post Anaesthesia care unit

where the vitals of the patients including the post operative pain will be

monitored using the visual analogue scale (VAS) ( Annexure 4). Post operative

pain on the visual analogue scale at 6 hours , along with opioid, NSAIDs

administration and length of hospital stay is recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients willing to give informed consent Patients posted for electiv haemorrhoidectomy patients with ASA grade 1 and ASA grade 2.

Exclusion Criteria

  • patients refusal in giving informed consent Age less than 18 years patients allergic to local anaesthetics patients with bledding diathesis,skin lesions,wound at the puncture site of proposed block pregnant and lactating women ASA grade 3 and ASA grade 4.

Outcomes

Primary Outcomes

To compare the effect of pudendal nerve block with spinal anaesthesia versus only spinal anaesthesia on postoperative pain (VAS score)at 6th hour in patients undergoing haemorrhoidectomy

Time Frame: immediate post op , 6th hour

Secondary Outcomes

  • To asses the quality of recovery in patients undergoing Haemorrhoidectomy(Immediate post op ,6th hour)

Investigators

Sponsor
DR Kamalieshree M
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DR Kamalieshree M

Bangalore Medical College and Research Institute

Study Sites (1)

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