To assess the efficacy of fentanyl and tramadol in post operative pain management and role of habbe shifa in preoperative patients.

Not yet recruiting

• Conditions: Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,

• Registration Number: CTRI/2022/12/048459
• Lead Sponsor: Department of Jarahat

Brief Summary

The international association for the study of pain define Pain as’ An unpleasant

sensory and emotional experience associated with actual or potential tissue damage

or describe in term of damage. Post operative pain can be divided into acute and

chronic pain. Acute pain is experienced immediately after surgery upto 7 days.

Effective postoperative pain control is an essential need of every surgical procedure

Pain pathway has three components :A first order neurone (cell body in dorsal root

ganglion) which transmits pain from a peripheral receptor to a second order neurone.A

Second order neurone in the dorsal horn of the spinal cord, through axon and

spinothalamic tract crosses the midline to reach thalamus where third neurone through

internal capsule reaches to post central gyros.

Enhanced recovery after surgery (ERAS) protocols introduced in 1997 are the pre

operative care protocols that promote early post surgical recovery.The purpose of this

to reduce post operative complications, patient discomfort and reduces the length of

hospital stay.Persistent post surgical pain (PPP) has a incidence of up to 30-50% and

has negative outcome of quality of life and negative burdens on individuals, family and

society.



Habb (Pill) is the earliest dosage form invented by unani physicians.Habbe Shifa is

widely used in the patients who are addicted to opium. Ingredients of habbe shifa as

per NFUM are tukhme dhatura , rewandchini, zanjabeel and samaghe arabi. Aqueous

and alcoholic extract of habbe shifa produce analgesic anti convulsant and antipyretic

activity.

Tramadol is a phenylpiperione analogue of codeine. It is a nonadrenergic serotonergic

and mild agonism of the opiod receptor i.e 1/10th of morphine. It has a half life of 4-6

hours.Tramadol is a centrally acting analgesic that has minimum respiratory depressant

effect.It also prevents neural toxicity by preventing setonin and norephinephrine uptake

in spinal cord. The most common side effect of this drug are Nausea, Vomiting,

Headache, dizziness, itching and hot flushes.

Fentanyl was one of a series of opioids synthesized in 1960. It is effective as opioid

analgesia with enhanced analgesic activity and potency and lesser side effects than

morphine.Fentanyl is a short acting opioid can be used as both intraoperative and

postoperative analgesia and can be given intravenously.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-17
• Study Start: 2022-12-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Open cholecystectomy Epigastric hernial repair Umbilical hernial repair Age between 18 – 65 years Both sexes Patients willing for surgery and spinal anaesthesia.

Exclusion Criteria

Patient of ASA3 Psychiatric patient Neurological disorder H/O coagulopathy Patient refusing for spinal anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemodynamic parameters	outcome was assessed post operative for first 24hours at every 2 hours
Pain was checked through VISUAL ANALOGUE SCALE	outcome was assessed post operative for first 24hours at every 2 hours

Secondary Outcome Measures

Name	Time	Method
Need of oxygen	Need of rescue drugs

Trial Locations

Locations (1)

Ajmal Khan Tibbiya College; 🇮🇳 Aligarh, UTTAR PRADESH, India

Ajmal Khan Tibbiya College

🇮🇳Aligarh, UTTAR PRADESH, India

Afeefa Naaz

Principal investigator

8851428104

afeefanaaz19@gmail.com