NCT05406765

Brief Summary

Investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. Investigators hypothesize that spinal anesthesia as an adjunct to general anesthesia will reduce postoperative pain and opioid requirements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
Last Updated

December 22, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

June 1, 2022

Last Update Submit

December 21, 2022

Conditions

Rectal CancerPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Nummeric rating scale (0-10), where 10 indicate worst possible pain.

    Worst pain scores in the first 48 hrs.

    48 hours after surgery

Study Arms (2)

Spinal

ACTIVE COMPARATOR

Spinal anesthesia

Drug: Bupivacaine Injection

Placebo

PLACEBO COMPARATOR

Placebo spinal

Drug: Bupivacaine Injection

Interventions

Bupivacaine InjectionDRUG

One group will receive bupivacaine 15 mg and morphine 100 ug intrathecally

Also known as: Marcain
PlaceboSpinal

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \*All patients undergoing laparoscopic abdominoperineal rectal amputation for rectal cancer \* Age 18-100 years are eligible for enrollment in the study.

You may not qualify if:

  • ASA IV,
  • BMI\>35,
  • contraindication to spinal analgesia
  • allergy to any of the drugs used in this study protocol,
  • chronic use of opioids or steroids,
  • liver or renal impairment,
  • patients scheduled for synchronous laparoscopic liver metastatic surgery
  • inability to communicate in Norwegian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Related Publications (1)

  • Antunes M, Baumgartel A, Gjessing PF, Ytrebo LM. Spinal Anaesthesia as an Adjunct to General Anaesthesia for Laparoscopic Abdominoperineal Rectal Amputation. J Pain Res. 2023 May 31;16:1855-1865. doi: 10.2147/JPR.S410019. eCollection 2023.

    PMID: 37284327DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsPain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lars M Ytrebø, PhD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomization, allocation, and blinding: Randomization will be conducted by using sealed, opaque envelopes. An independent colleague at the Clinical Research Department will randomize these envelopes in blocks of 5. These envelopes will be stacked and stored outside the operating room. The upper envelope will be opened by the attending anesthesiologist when an included patient arrives in the operating theater. The patient, surgical team, nurses on the ward, and researcher team will be blinded. Only the attending anesthetic team will be aware of the randomization. They will be instructed not to tell the patient or any other health care worker which group the patient was allocated to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

January 1, 2022

Primary Completion

October 7, 2022

Study Completion

October 7, 2022

Last Updated

December 22, 2022

Record last verified: 2022-05

Locations

NO(1)