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Inguinal Hernia UnilateralNCT06608056

Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair

A study testing Pain management after surgery in people with Inguinal Hernia Unilateral and Pain Management, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Inguinal Hernia Unilateral, Pain Management
What is being tested?
Pain management after surgery
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Jan 2024to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Undergoing elective primary unilateral open inguinal hernia repair under spinal anesthesia - Lichtenstein repair with prolene mesh
  • ASA I or II
  • Ages 18 - 65

Who cannot join

  • Patient on chronic pain meds
  • Patient receiving analgesics 24hrs prior to surgery
  • Incarcerated or strangulated hernia or recurrent hernia
  • BMI \>40
  • Allergic to medications being tested in this study

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Pakistan Air Force Hospital

    Islamabad, Capital Territory, 44000

Other trials in Pakistan

About this study

Official title: Comparing Opioid Vs Non Opioid Analgesics for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair

To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. We compared the use of opioids vs just non steroidal anti-inflammatory drugs on post-operative pain control following inguinal hernia surgery

Read the detailed description

Inguinal hernia repair is one of the most common surgeries performed by general surgeons worldwide. The preferred procedure for primary open inguinal hernias is open mesh repair (tension-free)-also called Lichtenstein repair. Opioids remain the mainstay for post-operative analgesia, however, they have a tendency for dependence along with other side effects. Non-steroidal anti-inflammatory drugs (NSIADs) have been used as adjuncts to decrease the use of opioids, however, usually NSAIDs are not used in isolation following surgery. We compared post-operative analgesia following primary open inguinal hernia repair, with patients receiving only opioids vs patients only receiving NSAIDs. 60 patients were randomized in to 2 groups. Group A patients received tramadol injection (opioid) every 8 hours, while patients in Group B received injection ketorolac (NSAID) every 8 hourly. Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery.

Being tested
Pain management after surgery
Keywords
Lichtenstein repair, ketorolac, tramadol, opioid, visual analogue score, non-steroidal anti-inflammatory drugs
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain management after surgeryDrug

    Patients in Group A received injection tramadol 50mg intravenously every 8 hours following surgery. Patients in Group B received injection ketorolac 30mg intravenously every 8 hours following surgery.

Study groups in NCT06608056
Study groupRoleWhat they receive
TramadolExperimentalPatients received injection tramadol 50 mg intravenously every 8 hourly following surgery
Receives: Drug: Pain management after surgery
KetorolacExperimentalPatients received injection tramadol 30 mg intravenously every 8 hourly following surgery
Receives: Drug: Pain management after surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue scale - pain score

    Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).

    Measured: 2-, 6-, 12-, 24-hours following surgery

Secondary outcomes (7)

  1. Flatus

    Time to passing flatus

    Measured: within 24 hours following surgery

  2. nausea/vomiting

    time when nausea/vomiting was not present in the patient

    Measured: within 24 hours following surgery

  3. Time to ambulation

    time after surgery when the patient started ambulating

    Measured: within 24 hours following surgery

  4. rescue analgesia

    number of times rescue analgesia was used

    Measured: within 24 hours following surgery

  5. Mean arterial pressure

    systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated

    Measured: 2-, 6-, 12-, 24-hours following surgery

  6. Heart rate

    Heart rate was measured at intervals in beats per minute

    Measured: 2-, 6-, 12-, 24 hours

  7. oxygen saturation

    oxygen saturation was noted at intervals

    Measured: 2-, 6-, 12-, 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start1 Jan 2024
  3. Primary completion28 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06608056
Sponsor's protocol ID
SGR-2021-137-2499-2
Other IDs
SGR-2021-137-2499-2
Status last verified
Sep 2024
First submitted
19 Sep 2024
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.

    PubMed 26329661

  • Zende, A.M. and R.R. Bhosale, Comparison of postoperative analgesic efficacy and safety of parecoxib and ketorolac in patients of inguinal hernia. International Journal of Basic and Clinical Pharmacology, 2013. 2(4): p. 414-20.

  • Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

    PubMed 30211382

  • De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.

    PubMed 21965355

  • Pavy TJ, Paech MJ, Evans SF. The effect of intravenous ketorolac on opioid requirement and pain after cesarean delivery. Anesth Analg. 2001 Apr;92(4):1010-4. doi: 10.1097/00000539-200104000-00038.

    PubMed 11273941

  • Chen JY, Wu GJ, Mok MS, Chou YH, Sun WZ, Chen PL, Chan WS, Yien HW, Wen YR. Effect of adding ketorolac to intravenous morphine patient-controlled analgesia on bowel function in colorectal surgery patients--a prospective, randomized, double-blind study. Acta Anaesthesiol Scand. 2005 Apr;49(4):546-51. doi: 10.1111/j.1399-6576.2005.00674.x.

    PubMed 15777304

  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington (DC): National Academies Press (US); 2017 Jul 13. Available from http://www.ncbi.nlm.nih.gov/books/NBK458660/

    PubMed 29023083

  • Goettsch WG, Sukel MP, van der Peet DL, van Riemsdijk MM, Herings RM. In-hospital use of opioids increases rate of coded postoperative paralytic ileus. Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):668-74. doi: 10.1002/pds.1338.

    PubMed 17072916

  • Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011 Jul;45(7-8):916-23. doi: 10.1345/aph.1Q041. Epub 2011 Jul 5.

    PubMed 21730280

  • Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.

    PubMed 24436674

  • Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.

    PubMed 11460814

  • Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.

    PubMed 10376632

  • Mulita F, Parchas N, Solou K, Tchabashvili L, Gatomati F, Iliopoulos F, Maroulis I. Postoperative Pain Scores After Open Inguinal Hernia Repair: Comparison of Three Postoperative Analgesic Regimens. Med Arch. 2020 Oct;74(5):355-358. doi: 10.5455/medarh.2020.74.355-358.

    PubMed 33424089

  • Burton, V. and P. A.J., Comparison of open and laparoscopic inguinal hernia repair. Mini-invasive Surgery, 2021. 5(26).

  • Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.

    PubMed 24022443

Questions about this trial

What is this clinical trial studying?

A study testing Pain management after surgery in people with Inguinal Hernia Unilateral and Pain Management, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale - pain score (time frame: 2-, 6-, 12-, 24-hours following surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06608056, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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