Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

NCT ID: NCT04835116

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-11

Study Completion Date

2019-10-11

Brief Summary

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The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Detailed Description

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The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Conditions

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Pain Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Local Anesthesia

Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.

Group Type OTHER

Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.

Intervention Type DRUG

Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.

paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Intervention Type DRUG

Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required

Intravenous Analgesics

Group B patients received postoperative intravenous analgesia.

Group Type OTHER

Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.

Intervention Type DRUG

Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.

paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Intervention Type DRUG

Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required

Interventions

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Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.

Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.

Intervention Type DRUG

paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required

Intervention Type DRUG

Other Intervention Names

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Local Anesthesia Intravenous analgesic

Eligibility Criteria

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Inclusion Criteria

* all patients undergoing PCNL
* age from 12-65 years
* normal renal functions
* no history of chronic pain
* ASA I, II \& III
* Both genders

Exclusion Criteria

* history of local anaesthesia allergy
* Redo PCNL
* Multiple punctures during PCNL
* Excessive intra-operative bleeding
* Diabetes mellitus
* Coagulopathy
* Mental disorder
* ASA IV \& V
* Active urinary tract infection.
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Armed Forces Institute of Urology, Rawalpindi

OTHER

Sponsor Role lead

Responsible Party

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Musab Umair Khalid

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Musab Umair, MBBS

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Institute of Urology.

Locations

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Armed Forces Institute of Urology.

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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AFIU Rawalpindi

Identifier Type: -

Identifier Source: org_study_id

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